Welcome to Insulin Dependent Diabetes Trust

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning that a small number of counterfeit NovoFine® needles for use with Novo Nordisk disposable and durable insulin pens, are on the UK market. The needles are not made by Novo Nordisk and do not meet quality standards.

· They are sized Fine 31g x 6mm and have the batch number 08J02S, expiry 08/2013.

· Lacks a line underneath the CE number on each box containing a hundred individual needles.

· Has a transparent glue on the top where the cannula is glued to the hub of the needle (the glue on a Novo Nordisk NovoFine® needle is white/yellow)

· Needle may not fit well on the device, as the thread is of inferior quality (this may cause leakage of insulin)

If in doubt as to whether a product is counterfeit Novo Nordisk and the MHRA recommend that patients contact their pharmacy or Novo Nordisk UK customer Complaints on 0845 6005055.

The MHRA has issued an ALERT of a manufacturing failure for the following lots of Owen Mumford Autopen® Classic (1 unit 3ml) insulin pens, which have been supplied in the UK since February 2008. The affected Lots are:

The lot number for is stamped on the white collar, found on the lower part of the pen body and is printed on the device packaging.

Affected pens may fail to dispense insulin but the dose knob will still click and return to zero, so the patient may think that a dose has been delivered. This risk of underdosing of insulin could lead to hyperglycaemia. Autopen Classic (1 unit 3ml) devices are the only devices affected and are specifically for use with Eli Lilly and Wockhardt UK insulin cartridges.

In September 2004, Novo Nordisk gave 18months notice that they were discontinuing several of their GM 'Human' insulins due to 'rationalisation of their portfolio'. But they have now brought this date forward to October 2005 as they state that stocks will be exhausted by this date as a result of 'continuing high demand for these products'.

Obvious question: if these insulins are in high demand, why are they being discontinued?

In addition, Novo Nordisk have now announced that GM 'Human' Actrapid Penfill [3ml cartridge] will no longer be available after the end of October 2005. This means that people who want to continue to use 'human' Actrapid will be 'forced' to use a 10ml vial and syringe. Of course, the Novo Nordisk recommended alternative is that people change to the short-acting insulin analogue, NovoRapid.

Obvious question: if your doctor thought that NovoRapid was the insulin most suitable for you, then surely he would have already suggested changing to it?

Under these circumstances, changing your insulin is not being done clinical reasons to benefit you but because Novo Nordisk have made yet another commercial decision. It is this commercial decision, not clinical need, which is dictating your treatment - something that must be deplored!

NOTE: there has been NO announcement about the discontinuation of pork insulin.

Overleaf is a chart produced by Novo Nordisk giving the discontinuation details and possible Novo Nordisk alternative insulins. If you do not want to change to GM insulin analogues or you have already tried them and had adverse effects, then there are other alternatives to consider and discuss with your 'suitably experienced healthcare professional':

· GM 'human' insulins made by Lilly - having said this, Lilly announced some time ago that preloaded pens, HumaJect S and HumaJect M3, will not be available after June 2006 but they will still be available in alternative delivery systems. More information from Customer Care Tel 01256 315999

· Animal insulin by Wockhardt/CP Pharmaceuticals - GM 'human' insulins replaced natural animal insulins and while animal insulins differ in their speed and duration of action, GM 'human' insulins are still more similar in action to pork insulin than to GM insulin analogues. Animal insulins are available for pen use.

Novo Nordisk state that 'any change of insulin therapy should be carried out by a suitably experienced healthcare professional' . This is particularly so when changing to insulin analogues because they have a different speed of onset, peak of action and different duration of action from both 'human' and animal insulins.

Obvious question: how is this going to take place before October 2005 when many people only go to the clinic once a year? Let us hope that we do not have a similar situation to the 1980s when pharmacies supplied people with GM 'human' insulin instead of their usual animal insulin without any information or professional advice. .

Again we see commercial decisions dictating treatment options, further reducing treatment choices for both patients and doctors, not to mention increasing NHS costs. We will be raising all these issues with Minister of Health, Lord Warner in July 2005.

November 14th 2003

US researchers at Massachusetts General Hospital have been able to halt, and even reverse, Type 1 diabetes in mice. The researchers had already shown that injecting diabetic mice with spleen cells from healthy mice re-educated their immune systems so that they could accept an islet cell transplant. However, the mice unexpectedly began to produce islet cells that could secrete insulin themselves and the latest research found that this only happened if the mice had been given a specific type of spleen cell. They can be distinguished from other spleen cells because they lack a particular molecule called CD45. It is the cells withut CD45 that are the precursors for pancreatic islets and they have a distinct function that has not previously been identified for the spleen.

To double check their findings, researchers carried out the same treatment giving female diabetic mice spleen cells from healthy male cells. They found that in the diabetic mice that achieved long-term normal glucose metabolism, all the new functioning islets had significant numbers of cells with Y chromosomes which means that they must have come from the male donors. In a further experiment, donor spleen cells were marked with fluorescent green protein and again these cells were found throughout the newly developed islets.

Dr David Nathan, director of the hospital's Diabetic Centre, says: "These exciting findings in the mouse model Type 1 diabetes suggest that patients who are developing this disease could be rescued from further destruction of their insulin-producing cells. In addition, patients with fully established diabetes possibly could have their diabetes reversed."
Clearly there is still along way to go, but things are looking more promising

When IDDT first formed in 1994 an important task was to collect information from people with diabetes and their family carers about their experiences with synthetic, so-called 'human' insulin. We sent questionnaires to everyone who contacted us and analysed the first 100 we received, the questionnaires that were received subsequently were all very similar to the first 100. We received the following information from this group of people:

· 41% - loss of warnings of hypos or ‘I seem to function on automatic pilot’.

In addition to this 24% Of those contacting IDDT said that their doctor was unwilling or reluctant to change their insulin to natural animal insulin and 3% told us their doctor didn’t listen or said the problems were ‘all in the mind’.

· ‘I didn’t realise that ‘human’ insulin was not derived from humans’.

The National Institiute for Clinical Excellence [NICE] has advised that Tamiflu, an anti-flu pill, should be made available on the NHS to people 65 and over and younger people with serious health conditions, including diabetes. Tamiflu is the only treatment that can be taken orally in a capsule or syrup and is the first drug to be licensed to treat flu in children.

It is designed specifically to target the influenza virus by stopping the virus sticking on to the cells of the respiratory tract. Normally the virus then reproduces but Tamiflu also stops this happening. It works in the same way as Relenza but this has to be inhaled, making it hard for some elderly people to take.

The chief executive of NICE told the BBC that vaccination is still the most effective way to prevent flu-related illness but Tamiflu increases the options for at risk groups.

People with diabetes are an at risk group and therefore entitled to free flu vaccinations on the NHS.

The Novo Nordisk range of synthetic human insulins are to undergo a name change and there will also be packaging changes. The insulin products will remain the same and so there will be no need for a change of insulin type, dose or regime. These changes will take place over the next 6 months.

The name changes mean that the word 'Human' will be omitted so that for example, what is now 'Human Actrapid' will become simply 'Actrapid'.

The above insulins, as well as Novo Nordisk 3ml Penfill cartridges, will be subject to changes in the packaging and the patient information leaflets.

These changes have been approved by the EU Commission and will apply throughout Europe resulting in the same brand names being available in all European countries.

The names of Novo Nordisk pork insulins will NOT change but it is important to ALWAYS check that you have the correct insulin BEFORE leaving the pharmacy.

The names of Pork Actrapid and Pork Insulatard will NOT change. However, IDDT has concerns that there could be confusion when a prescription for Novo Nordisk pork insulin is dispensed. Not stating the word 'human', or some other alternative such as synthetic or GM, in the name or on the pack, could lead to GM Actrapid or GM Insulatard being dispensed by the pharmacist instead of Pork Actrapid or Pork Insulatard.

We are assured by Novo Nordisk that the new human insulin packs look very different from the pork insulin packs and that there will be a warning on the side of the packs for the first 6 months. This should help to avoid confusion but IDDT issues the following warning:

ALWAYS check that you have the correct insulin BEFORE leaving the pharmacy.

However, IDDT does have concerns that as a result of these changes it will no longer be possible to easily recognise that Novo Nordisk's range of human insulins are actually GM synthetic insulin. Again we are assured by Novo Nordisk that the Patient Information Leaflet for the 'human' insulin range clearly states in bold type in Section 1 that the insulin is human. Yet another reminder:

ALWAYS read the Patient Information Leaflet even if you have been using insulin for years, because this is where any changes will be reported.

We have discussed our concerns with Novo Nordisk and they are going to issue warnings to pharmacists through pharmacy journals and supply fridge magnets to pharmacies. It remains to be seen if this will totally prevent mistakes happening, not just for the next 6 month but indefinitely.

Glitazones are oral drugs for the treatment of Type 2 diabetes and that are insulin sensitisers to enable the body's insulin to work more effectively. The first glitazone, troglitazone [Rezulin], had to be withdrawn from the market when it was suspected of causing 400 deaths from liver failure, but after not until 2 years after the reports were first received after scandal and the threats of whistle-blowing.

Avandia and Actos, from the same family of drugs, were introduced about a year before troglitazone was withdrawn. It was claimed that these drugs did not cause the same problems, later proved not to be entirely correct when warnings of serious liver and cardiac complications appeared.

NICE, the National Institute for Clinical Excellence, first issued guidance on glitazones in March 2001. It recommended that glitazones were effective at reducing blood glucose when added to either metformin or a sulphonylurea but only in people whose blood glucose could not be adequately controlled by one of these drugs on their own [monotherapy]. Now NICE have updated reviewed and changed this guidance as a result of new research.

· The use of a glitazone [Avandia and Actos] added to either metformin or a sulphonylurea as an alternative to treatment with a combination of metformin and a sulphonylurea, is not recommended. The exceptions are for people who are unable to take these two drugs because of intolerance or a contraindication to one of them.

· If glitazone combination therapy is used, then its efffectiveness should be monitored against targets for glycaemic control and for other cardiovascular risk factors, including lipid profiles.

· The combination of metformin and a sulphonylurea should remain the first treatment choice where treatment with one of them on their own has failed to achieve adequate blood glucose control.

· A glitazone should be used in combination with metformin or a sulphonylurea ONLY in people with Type 2 diabetes for whom monotherapy hasn't worked to control blood glucose and cannot take the combination of metformin and a sulphonylurea because it is not suitable for them or they cannot tolerate its side effects.

· The licences for glitazones do not permit the use glitazones as triple therapy ie with the combination of metformin and a sulphonylurea or with insulin.

NICE recommends that if you or someone you care for has Type 2 diabetes, you should discuss this guidance with your doctor.

Further information can be obtained from the NICE website www.nice.org.uk and the full guidance can also be requested by telephoning 0870 1555 455

Avandia - the manufacturer, GlaxoSmithKline [GSK], is facing legal action in the US by 32 people, some of whom claim that they needed liver transplants within weeks of starting the drug. They claim that the company failed to adequately warn patients that Avandia could cause serious cardiac and liver complications and was slow in reacting appropriately with additional warnings once these reports were made known to them. GlaxoSmithKline deny these claims - to be expected when Avandia, used by 3 million people with sales rising last year by 19% to £809 million!

Legal actions continue with troglitazone - in April 2003, a New York jury ordered the manufacturer, Pfizer, to pay $2million damages compensation to a woman who was injured after taking troglitazone. Pfizer is appealing against similar verdicts in other States. Recently a federal appeals court reinstated a $1.4billion [£834million!!!] lawsuit against Pfizer brought by health insurers to recover the amounts they paid for drug and subsequent liver testing between Feb 1997 and April 2001.

In October 2002, we reported that trials of Novo Nordisk’s new insulin sensitiser drug were stopped because bladder tumours were found in mice and rats. In January 2003 Novartis, halted development of their new dual sensitiser drug for the same reason – tumours in mice and rats.

On July 8^th CP Pharmaceuticals announced that it had been acquired by Wockhardt Ltd, a leading Indian pharmaceutical company. This transaction makes CP a subsidiary of Wockhardt.

· With the acquisition of CP Pharmaceuticals, Wockhardt's annual sales in the UK alone touches 50million sterling pounds, making it one of the top 10 generic companies in the UK.

· Wockhardt is one of India's leading phramaceutical companies with sales of 105million sterling pounds. It has 11 manufacturing facilities, three of which are approved by the FDA in the US.

· Very soon it will become the world's fourth manufacturer of recombinant human insulin.

· CP has four key businesses consisting of hospital drugs, generics, contract manufacturing and exports.

· Some of CP products have significant market shares in the UK and these include Hypurin Bovine insulin [100%], Hypurin Porcine insulin [34%].

Naturally concerns have been expressed about the future of the range of Hypurin animal insulins and on July 14^th a press release was issued stating the following:

"CP and Wockhardt would like to confirm that the supply of Hypurin porcine and Hypurin bovine insulin continues unchanged.

CP has been dedicated to the production of natural porcine and bovine insulins for over 30 years and has further invested in the product range with the recent launch of hypurin 3ml cartridges. CP's investment has demonstrated a clear commitment to ensure continued supply of Hypurin insulin for the foreseeable future."

We have been aware for some time that an acquisition of CP was in the pipeline and we welcome the reassurances from Wockhardt and CP that supplies of natural pork and beef insulins will continue.

It is understandable that there are concerns about future availability. While IDDT has always maintained that this is a worry that people should not have to face on top of having to live with diabetes itself, these concerns are not knew to people who are reliant on natural animal insulin for our future health an wellbeing.

It is important to look on the positive side too, who knows it could be that Wockhardt look to expanding the animal insulin business so that more people are aware of the existence and advantages that animal insulins can have for some people.

As part of the acquisition Mr Charles savage will be stepping down as Chief Executive of CP, the good news is that he will remain in a consultancy capacity for two years.

IDDT would like to express our most sincere gratitude to Charles for CP's commitment to the ongoing supplies of natural insulins under his leadership. However, we would also like to thank him for his personal commitment to helping and understanding the people who need animal insulins. This commitment has often extended far beyond the call of duty and is appreciated by people in many different countries.

Wockhardt announced that they are launching a synthetic 'human' insulin in India derived from yeast and is called Wosulin. It is the first synthetic insulin to be manufactured in India as the large multi-national companies have only assembled and packaged in the country. Until now 90% of the Indian insulin market has been for pork and beef insulin prescribed for the Muslim and Hindu communities respectively.

" But medical experts believe that selling the new product to an existing patient will not be easy because switching over to the new insulin might lead to complications."

We must be thankful that the diabetic community in India is being warned by their diabetes experts that there may be complications with the changeover - something that the experts in developed countries failed to do. Perhaps the experts in India have gained from our experiences.

Wockhardt are pricing a 10ml vial of Wosulin at 129Rs [nearly $3] and will be the cheapest insulin on the market. They will also be marketing the insulin globally and this could have implications for people in developing countries who cannot afford the high costs of the insulins produced by Lilly, Novo Nordisk and Aventis.

On a slightly lighter note, the BBC News item headline describes the rDNA insulin as 'vegetarian' insulin. That's a new one!

NICE [National Institute of Clinical Excellence] has now issued guidance on the use of insulin pumps that hopefully will clarify the situation for people wanting to use pump therapy to control their diabetes. Until now there have been variations in whether or not the local NHS will pay part or all of the costs of the pump and the ongoing consumables.

Insulin pump therapy is recommended as an option for people with Type 1 diabetes provided that:

· Multiple dose insulin [MDI] therapy has failed, including the use of insulin glargine [Lantus].

· Those receiving the therapy are willing and able to use the therapy effectively.

· Insulin pump therapy should be provided by a trained specialist team [physician specialising in pump therapy, diabetes nurse and dietician].

· People beginning pump therapy should be provided with training in its use and ongoing support.

· These recommendations for Type 1 diabetes are also valid for children, adolescents, pregnant women and women who are intending to become pregnant. However, because of the risk to the fetus, pregnant women and those intending to become pregnant should only switch to insulin pump therapy under the care of a specialist team.

· Established users of pump therapy should have their insulin management reviewed as they may be suitable for a trial of insulin glargine [Lantus], along-acting insulin like medication.

· Pump therapy is not recommended for people with Type 2 diabetes who require insulin.

NICE considers that insulin therapy has failed when someone has been carefully trying to manage their diabetes but has been unable to keep their blood glucose levels within recommended levels resulting in ‘disabling hypoglycaemia’. This means that they have repeated and unpredictable hypoglycaemic episodes which mean that they require help from other people and which make then anxious about the episodes reoccurring and significantly spoiling their quality of life.

"This is people for whom it has been impossible to maintain HbA1c level no greater than 7.5% [or 6.5% in the presence of microalbinuria or adverse features of metabolic syndrome] without disabling hypoglycaemia occurring despite a high level of self-care of their diabetes."

The estimated cost of switching all potentially eligible people to insulin therapy would be around £3.5million per year. This is based on 1-2% [2000 to 4000] of people with Type 1 diabetes would move to pump therapy.

NICE is part of the NHS and is an independent organisation responsible for providing national guidance for health professionals, patients and their family carers, on treatment and care in the NHS in England and Wales. In January 2002, the government announced a statutory obligation for the NHS to provide funding for treatments and drugs recommended by NICE but only if considered appropriate by the doctor and the patient. So NHS organisations locally have to make resources available within 3 months to enable NICE recommendations to be implemented.

Once NICE guidance is published healthcare professionals are expected to take it fully into account when exercising their clinical judgement. But NICE guidance does not override the individual responsibility of health professionals to make decisions appropriate to the circumstances of the patient in consultation with the patient and/or their guardian or carer.

NICE has issued guidance on other aspects of diabetes and these can be found by visiting www.nice.org.uk

Cialis - Lilly has introduced this new drug for the treatment of impotence. Its effects last for 24 hours and so the manufacturers say that it will allow men with erectile dysfunction to choose when they want to have sex and will allow couples greater spontaneity. The publicity material says that in clinical trials Cialis worked in four out of five men. Like Viagra it will only be available on the NHS to certain patients.

Vardenafil or Levitra - this is a new drug introduced by Bayer/GlaxoSmithKline for the treatment of impotence. Clinical trials have shown that Bayer/GlaxoSmithKline is effective and reliable in a wide range of men with erectile dysfunction. Among men with diabetes 73% taking 20mg vardenfil showed a significant improvement in erections. Most adverse events were mild to moderate and transient - headache, flushing, rhinitis dyspepsia, nausea and dizziness. Vardenafil is taken orally 25 to 60 minutes before sexual activity and is effective up to nearly 5 hours later.

Viagra was the first impotence drug to be introduced and all three are available on NHS prescription to men with diabetes but this is limited to four tables per month

Lantus is a CLEAR long acting insulin

Insulin glargine, called Lantus by Aventis, is a long acting basal insulin analogue. It is being proclaimed as the first truly long acting insulin. It does seem to have been forgotten that there used to be a truly long acting beef insulin before it was discontinued and this was widely used particularly in people with Type 2 diabetes.

Lantus has been available in the US for some time and in the UK came on the market in August 2002. Initially it received approval for single injection at bedtime but the first changes to its use were made in December 2002, when Lantus received European approval for use in children over the age of 6years and for flexible injection times. [Perhaps an attempt to avoid the early morning hypos?]

The introduction of Lantus is thought to be an important milestone in managing diabetes because it has a smoother action over 24 hours than previous long acting insulins. Much of the research seems to be in people with Type 2 diabetes and it has shown that there is a reduced risk of hypoglycaemia when using glargine [Lantus] as opposed to the usual ‘human’ long acting insulin [isophane/NPH].

At an Aventis sponsored symposium at the annual professional conference of Diabetes UK 2002:

Professor David Owens said that compared to existing long acting insulin [remember research has only compared it to ‘human’ and not animal]:

· it has greater molecular stability [research has only compared it to ‘human’] and this results in a flat action profile compared with an early peak in present longer acting insulin. Thus there is less risk of hypoglycaemia.

· It is well tolerated and at least as effective in as present longer acting insulin.

· It has not been shown to improve HbA1cs but is at least as effective at helping to maintain target HBa1c levels but with less risk of hypoglycaemia. [Does this mean that it has been proven that there are actually less hypos or just less of a risk in theory?]

Unlike all other long acting insulins Lantus is not milky but clear. Diabetes specialist nurse, Ms Jill Hill said at the symposium that this was an advantage because it would not have to be shaken before injections and that this was ‘just one less thing that patients will have to remember to do.’ But practical experience of using this new clear long acting insulin in daily life in the US, is a little different! A letter from physicians in Diabetes Care, Feb 2002, warns that two of their patients that they describe as having ‘excellent compliance’, injected their very rapid short acting Humalog instead of their Lantus [glargine] by mistake. This is an easy mistake to make, especially when tired before going to bed and fortunately both these people realised what they had done and remedial action was taken. Perhaps we would all rather shake the bottle than run this risk.

Aventis obviously were aware of the risk of confusion with the short acting insulins, because Lantus is marketed in a different shaped vial from all other insulin vials – it is longer and thinner and the label is in purple writing.

LANTUS – a mixed response from you!

In our January 2003 Newsletter we gave a cautionary note that this a new insulin and like all new drugs we have to see what happens when used in much larger numbers of people and over a longer time.

Lantus is being well received by the medical profession - many people are being changed to it even when they are having no problems with their existing insulin. Some people who ask for a change to animal insulin are being indirectly or directly refused but given Lantus instead. Unfortunately some are being given misinformation and told that Lantus is not synthetic or a GM insulin. Of course it is, it is made by a process that uses a transformed E.coli K12 host strain!

Lantus does sound like the answer to a prayer – one injection a day of long-acting with no peak of action and a reduction in night hypos, or so the blurb says. But we have received a lot of concerns from people using Lantus as well as some people who think Lantus is the best thing since sliced bread. In reporting this, we are very aware that people having problems are far more likely to put pen to paper than those who are happy with their new Lantus, but once again this demonstrates that people are different and what suits one person does not necessarily suit another.

It is important to note that the following reports came from both ‘human’ and animal insulin users.

Some good ones - no peak of action is much better and one report where hypo warnings are present at 3.2 but were rarely present on ‘human’ insulin.

· Similar adverse effects on Lantus to those experienced with ‘human’ - headaches, extreme tiredness, mental confusion etc but on returning to animal insulin these have disappeared.

· a very noticeable problem reported by quite a few people is painful joints and swelling of joints and hands within a short time of starting Lantus. This disappears with a return to their normal insulin.

· Hypos in the early morning ie 6.00am as opposed to the middle of the night but the Patient Information Leaflet warns of this. However, as one person said, if you are asleep, early morning hypos are not a lot different from night hypos and nor do they make you feel very good to begin a day’s work!

IDDT found these reports not only of concern but disappointing because we also hoped that Lantus would be wonderful and hoped it would be the ‘synthetic’ answer for people who can’t use ‘human’ insulin. So we looked further, to the European approval papers and to the NICE Guidance for Lantus:

Lantus was recommended for marketing authorisation subject to chemical, pharmaceutical and biological, as well as clinical follow-up measures being undertaken by the company, Aventis. The document makes it clear that “major safety issues were identified” and so the licence was granted providing the company followed these up.

The document itself is scattered with expressions such as ‘it is likely that’, ‘it is assumed that’, ‘it is not expected that’ – assumptions rather than proof which sounds familiar!

It should be noted that in trials Lantus was only compared to ‘human’ long acting insulin [isophane or NPH] either injected once or twice daily. However the Agency concluded that:

“Lantus is as effective as ‘human’ insulin with respect to glycaemic control but major safety issues were identified - hypoglycaemia, local reactions/toxicity, immunological reactions/antibody formation and ocular safety.”

Lantus is comparable to other long acting insulins in Type 1 and Type 2 diabetes and HbA1cs were about the same. So as yet, it has not been shown to be better than other insulins – just comparable.

· After injection Lantus is left under the skin [called the depot effect] for slow release. Studies in rats, mice and dogs showed that the period during which Lantus is released from the injection site increased with increasing dose. Our Question - so presumably the bigger the dose, the longer it lasts?

· Studies to look at the absorption of injected Lantus showed that after 24hours 50% of the insulin was still left at the injection site and after 48hours the amount of Lantus still left at the injection site was 20%. Some of the insulin may be metabolised at the injection site but no studies were performed to address the question of the possible accumulation of active insulin and its metabolism at the injection site and the document stated that this was a point of concern. The manufacturer agreed to carry out follow up studies to address this [once it is on the market.] Our Questions – So is Lantus a truly 24hour insulin or actually a 36hour insulin? Does the overlap of absorption from one day to the next account for the unexpected hypos?

· In rats and dogs there were changes at the injections sites including subcutaneous fibrosis, sclerosis and inflammation. Malignant Fibrous Histiocytomas were found in both rats and mice at the injection sites but this was not related to the dose but the low acidity of the Lantus solution. Apparently these tumours are commonly found in subcutaneous tissue when solutions that are not neutral are used. There was no evidence of local cancers in humans. Our Question – should this not have been investigated further BEFORE Lantus was given approval, especially as we know that one insulin analogue was scrapped before reaching the market because it caused tumours? Shouldn’t people using it be told of this risk, however small?

· In studies where hypoglycaemia was induced in healthy people and those with Type 1 diabetes, Lantus and ‘human’ insulin had similar neuroglycopenic [effects of hypoglycaemia in the brain] and counter-regulatory hormone responses. Our Question – so does this mean that people who have problems with hypos and loss of warnings with ‘human’ insulin will also have problems with Lantus?

The major safety concerns identified by the EMEA

· If people had previously used a regime of injecting their long-acting once a day, then there were less night hypos with Lantus. But if people had previously injected their long-acting insulin twice a day, morning and evening, then there was a greater increase in hypoglycaemia with Lantus even with a 20-25% reduction in dose of Lantus.

· After the initial phase, the frequency of hypos with warnings and the incidence of severe hypos were the same with Lantus and ‘human’ long-acting insulin. BUT there was a higher incidence of hypos without warnings in people using Lantus. The document says that Lantus is as safe as ‘human’ insulin. [wry smile!]

· As there is still some insulin left at the injection site after 24hours, this prolonged exposure of relatively small areas of tissue may result in local toxicity. Careful post marketing surveillance is recommended to monitor the appearance of serious local reactions.

· Direct quote: “The occurrence of injection site Malignant Fibrous Histiocytomas in rats in pre-clinical studies raised concerns as to the carcinogenic potential of Lantus but following careful evaluation of the relevance of these findings, it was concluded that at present the carcinogenic potential is not a point for particular concern. However, in view of the lack of clinical experience following long-term exposure to Lantus careful post-marketing surveillance will be required in order to monitor the appearance of more serious local reactions.”

Two of the four studies investigating the incidence of retinopathy showed a significant increase in retinopathy in patients treated with Lantus although when the four studies were put together and analysed there was not a ‘meaningful difference’ between Lantus and ‘human’ isophane/NPH. This could be linked to better control with Lantus as initial improved control has been shown to increase retinopathy in previous studies. However, the document says that ‘during the clinical trials, the influence of Lantus on ocular safety is unclear’ and so the manufacturers provided experts who concluded that there is no reason to suspect that there is an increased incidence of adverse ocular reactions associated with Lantus treatment.

The NICE appraisal of Lantus, published in December 2002, looked only at blood glucose control, hypoglycaemia and cost effectiveness. It makes no references at all to the other ‘major safety issues’ of the European Medicines Evaluation Agency. Somewhat worrying!

But let us not pre-judge or be too negative! It is early days and we must wait for independent post-marketing research to give us the complete picture. No doubt Lantus will suit many people but the one thing we do know even at this stage, is that Lantus is not the answer for everyone and so there is still a need to maintain the full range of animal and synthetic insulins to suit all needs.

We also must not forget that the European document did not mention the adverse effect that has been reported to IDDT by several people – joint pains and swellings.

Remember! If you come under pressure to change to Lantus, you do not have to change. If you don’t like saying no to your doctor or DSN, you can use a non-aggressive approach by saying that as it is new insulin, you will wait for post-marketing research.

AVANDIA AND ACTOS - more warnings!

IDDT’s October Newsletter reported that drug regulatory bodies had again issued warnings about these two drugs. They are:

· Not to be used in people with heart failure, fluid retention or liver disease

· Not to be used with insulin.

Despite these warnings, IDDT continues to receive calls from people who have been prescribed Avandia or Actos in addition to their insulin. We can only repeat our previous advice that if you are taking insulin and have been prescribed Avandia or Actos, you should discuss this with your doctor straight away. On requesting a change to animal insulin, one lady was told by her diabetic clinic to ‘try Avandia with your present insulin. It’s not licensed for this use but we’re trying it’!!! Needless to say, the lady refused but still didn’t manage to persuade them to give her animal insulin!

Avandia next stage - the manufacturers of Avandia, GlaxoSmithKline, have just received the approval for Avandamet in the US and they say they are committed to making it available in the UK. This is a combination of Avandia and metformin. It is worth remembering that the Canadian Therapeutics Initiative states that “Long-term trials are required to know whether this class of drugs [Avandia and Actos] reduce morbidity and mortality.” Yet before this is done, the manufacturers produce another similar drug and the US regulatory authority happily approves it a year sooner than even the drug company expected! Avandamet is expected to help sales of Avandia to reach £1.5billion by 2006!

Avandos [rosiglitazone] and Actos [pioglitazone] are both drugs for the treatment of Type 2 diabetes. In the UK they should only to be used in combination with one of the other oral drugs for Type 2 diabetes, metformin or a sulphonylurea and only when adequate blood glucose control cannot be achieved with these drugs. However in the US Avandia and Actos can used either on their own or in combination with either of the other two drugs. Neither of them is approved for use with insulin.

They belong to a class of drugs known as the thiazolidinediones or glitazones and the first drug of this type, troglitazone [Rezulin] was withdrawn from the market following at least 92 known deaths in the US from liver failure and/or congestive heart failure. The withdrawal in the US hit headlines because the FDA delayed this withdrawal for as long as 2 years despite adverse reports from a group of its advisers. It was withdrawn in the UK within 6 weeks of arriving on the market.

Avandos and Actos are successors to troglitazone and from the outset prescribing doctors have been advised that patients using either of these drugs should have regular liver function tests. It has also been known that they can cause fluid retention [oedema] that can lead to congestive heart failure, especially in people with an existing heart condition.

New Warning from the US Food and Drug Administration [FDA] 26.4.02

On April 26^th 2002 the FDA issued a new warning advisory notice warning that the class of drugs thiazolidinediones or glitazones, which includes Avandia and Actos, may cause fluid retention that can progress to heart failure. They should not be used in people who have or have had heart failure, fluid retention or active liver disease.

· Patients who develop oedema, shortness of breath, weakness, fatigue or sudden weight gain should advise their doctor immediately

They also warn that it is important to note that people with Type 2 diabetes are at an increased risk of diabetes related complications such as heart failure whether they take any specific type of diabetes treatment or not.

Following discussions with the FDA, the manufacturers of Avandia and Actos have issued letters to health professionals reminding them of these safety concerns.

NOTE: It is has to be noted that Takeda Chemical Industries, Japan's largest drugmaker, warned Japanese doctors of potential dangerous side-effects of its diabetes drug Actos as early as October 2000. The company was urged to issue the warning by the Health and Welfare Ministry after five of the 90,000 Actos users in Japan suffered non-fatal heart failure.

Health Canada issued warnings about Avandia and Actos in November 2001, Health Canada warned Canadians of their safety concerns related to the use of Avandia and Actos. Their reasons were the same as those of the FDA although they were issued 6 months sooner. Health Canada said that neither of these drugs should be used in patients with acute heart failure or active liver disease and patients who develop oedema, shortness of breath, weakness, fatigue or sudden weight gain should advise their doctor immediately. At the time these warnings were issued four deaths had been associated with Avandia. On checking the website of the Therapeutics Initiative in Canada [a body that functions rather like the UK’s NICE] they state “Long-term trials are required to know whether this class of drugs reduces morbidity and mortality outcomes”. Worth noting!

In two 26-week trials involving 611 people with Type 2 diabetes, two different doses of Avandia plus insulin were compared to insulin treatment alone. The participants included people with long standing type 2 diabetes and a high prevalence of cardiovascular conditions. There was an increased rate of heart failure and other cardiovascular side effects in patients taking Avandia and insulin compared to those taking insulin alone or a placebo. Similar results were found in another study comparing Actos plus insulin with insulin only therapy.

Pork insulin is still available from Lilly in the USA – despite the misinformation from pharmacies and healthcare professionals

Updated April 2003

Eli Lilly do not supply pork insulin in the UK but they are the only supplier in countries such as the US and Canada. All beef insulins in these countries have already been withdrawn leaving pork insulin as the only available animal insulin for people who have adverse reactions to ‘human’ insulin. Unfortunately some people find that pork insulin has similar effects as ‘human’ insulin, but for others pork insulin is a better option than ‘human’ and certainly worth a try before going to the lengths and expense of importing beef insulin from the UK.

Naturally people are concerned about the future supplies of pork insulin, so IDDT wrote to Lilly to inquire about future availability. On August 15^th 2001 we received a letter from John H Holcombe, MD, the Medical Adviser in Lilly’s Diabetes Care division that says:

"I am pleased to reiterate that Lilly has no plans to discontinue the sale of purified pork insulin, even though its use is small and continues to decline. We will, however, continue educational efforts directed towards physicians and patients about the physiological advantages of human insulin and its analogs."

So the good news is that at this moment in time Lilly says that they have no plans to discontinue pork insulin but we have to be aware that this actually means that the plans could materialise at any time.

The FDA have also confirmed to IDDT that Lilly pork insulin is available in the US. If you have difficulty obtaining it, visit IDDT-US by clicking on the US flag

Eli Lilly supply pork insulins in the US and Canada and a Canadian recently it was rumoured yet again that Lilly are withdrawing pork insulins from these countries. IDDT has checked this and as far as we are aware this is UNTRUE only pork lente is being discontinued. Pork regular [short-acting] and pork NPH [intermediate-acting] insulins, will continue to be available.

Exemption from prescription charges

December 2002

People with diabetes treated insulin and tablets are entitled to free prescriptions, providing they have a medical exemption certificate. These have been obtained from your local health authority but from October 2002, the Prescription Pricing Authority [PPA] has taken responsibility for issuing Medical Exemption Certificates, Pre-payments Certificates and Maternity Exemption Certificates. There are new arrangements for applications that are an improvement on the old system.

Redesign of the application forms [FP92A] – the patient completes parts 1 and 2 and the GP fills in the rest. As part of this arrangement the GP can authorise someone in the practice to sign the forms. The PPA has supplied GPs with pre-addressed envelopes and asked them to return these on a daily basis.

Redesign of the exemption certificate – this will now be a plastic credit card style to fit easily into a wallet.

Start dates and reminders – the start date of the exemption certificate will be the first day of the month in which the application is received. The certificate is valid for 5 years and 21 days before the end of this period a renewal reminder will be sent out. In the past reminders have not been issued, so this improvement will ensure that the exemption does not lapse.

Note: IDDT welcomes this new reminder system, although we have to wonder about the administrative costs involved for a condition such as diabetes which is not going to go away and therefore exemption will continue indefinitely.

Device Alert – Lilly HumaPen Ergo insulin pens

Medical Devices Agency [MDA]

10 June 2002

The MDA and Eli Lilly have received reports of the breakage of both engagements tabs on the blue insulin cartridge holders for the HumaPen Ergo injection pen. Some of these breakages have meant that people have given themselves insufficient insulin resulting in loss of blood glucose control. The breakage can usually be identified by the user when the pen is primed prior to injection.

Lilly has made design changes to the cartridge holder as a result of these reports. The original blue cartridge holder has been replaced with a clear one since when there have been no reported breakages.

This Device Alert has been issued to remind healthcare professionals of the insulin cartridge holder replacement programme being run by Eli Lilly because there is still a significant number of users that have not yet had there cartridge holder replaced.

· If the cartridge holder is clear, then no further action is needed. Pens with blue cartridge holders were not distributed after October 2000.

· If the cartridge holder is blue, it should be replaced and a new clear holder fitted.

· New clear cartridge holders can be obtained from Lilly on freephone 0800-085-3847 or from community pharmacists, diabetes clinics and dispensing GPs

Zyban is a drug licensed to help people to stop smoking. Since it was first on the market it is estimated that 419,000 people have used Zyban. But the Committee on Safety of Medicines [CSM] have received over 5,000 Yellow card reports of adverse reactions. 126 of these reports were of people having seizures.

· they have warned that the use of Zyban is contraindicated in people with certain conditions where there is already a risk of seizures.

· they have stated that there are certain conditions where Zyban must NOT be prescribed and these include people treated with oral hypoglycaemic and those treated with insulin. Clearly this means that people with Type 1 and Type 2 diabetes should NOT be prescribed Zyban. They state that the exception to this is where there is compelling clinical justification that the potential benefit of stopping smoking outweighs the increased risk of seizure.for prescribing Zyban.

ACCU-CHEK ADVANTAGE II – new information from Roche Diagnostics

April 2002

Glucose test strips. When you open a new container of test strips, don’t just throw away the Patient Information Leaflet because you have read it before! If the manufacturers make changes or issue new warnings, the information will be in the Patient Information Leaflet, so it is important to read it. Here is an example of why.

Roche Diagnostics have issued new information that although the result displayed on the Accu-Chek Advantage ll meter is correct, it is possible that not more than once every

· If the time and date on your meter is set correctly then this will only apply if you do a blood glucose test between 12.00 midnight and 12.10am

· If the time and date is not set on the meter then one blood glucose test every 7 days cpuld be incorrectly stored in your meter memory.

This warning is particularly important if you or your doctor use the blood glucose results stored in your meter’s memory to make adjustments to your insulin regime.

Anti – cholesterol drug withdrawn from the market

August 8 2001

Bayer, the well known German pharmaceutical company have withdrawn their lipid lowering drug, cerivastin [Baycol] from the market in every country except Japan. Baycol has been linked to 31 deaths in the US and at least 9 in other countries caused by the destruction of muscle cells that are then released into the bloodstream. This condition is known as rhabdomyolysis and can be life threatening. The people most at risk from Baycol are elderly people on high doses and especially when used in combination with another cholestrol drug, gemfibrozil. 12 of the US deaths were in people also taking gemfibrozil.

Baycol is one of the range of drugs called statins that reduce cholesterol. All statins have been linked to the side effect of muscle destruction but Baycol has been linked to significantly more cases than its competitors. One of the other well-known statins is Lipitor and this is now likely to replace Baycol as the biggest seller. The FDA , the US drug regulatory body, say that there are no plans to strengthen the warnings on the other statins but people taking them who suffer muscle pain should visit their doctor to review their medication.

The other symptoms of rhabdomyolysis are weakness, tenderness, fever, dark urine, nausea and vomiting. If people become aware that they are developing this muscle disease they can stop the drug and recover.

Public Citizen, the consumer advocacy group in the US, is preparing to petition the FDA to strengthen warnings on all statins by requiring that all patients receive warnings of the risk of rhabdomyolysis.

People with diabetes are at greater risk of heart disease and therefore if there cholesterol levels are higher than normal, they are likely to receive treatment with statins.

GlucoWatch Launched in the UK

Not a replacement for conventional finger prick blood glucose tests!

12 June, 2001

Recently Cygnus announced the launch of the GlucoWatch Biographer in the UK, the new monitoring system to check blood glucose levels. It measures blood glucose levels every 20minutes and an alarm sounds if the blood glucose levels are too low. However, many of the articles in the press are misleading and could cause harm to people with diabetes who may purchase such a device. It was not made clear that this development is yet far from a safe replacement for conventional finger pricking blood glucose testing.

In clinical studies conducted by the manufacturer, 25% of the time the GlucoWatch results differed from finger prick testing by more than 30%. In addition, it sometimes gave erroneous readings and was less effective at detecting very low blood glucose levels, the very reason that people need such a device with a reliable alarm system! It would not measure at all if the arm was too sweaty and caused mild to moderate skin irritation in at least 50% of patients.

The approval granted by the FDA in the US is rightly strictly limited. In the US it will be only be available on prescription to people 18 and over and because of the potential for error the FDA advises that the GlucoWatch should be used in conjunction with conventional finger prick tests.

When I contacted the company on the advertised phone line, they could not confirm that the GlucoWatch had been approved by the Medical Devices Agency [MDA] in the UK or that the MDA had issued similar advice to that of the FDA. Indeed, I could have purchased a GlucoWatch on the telephone without a doctor’s prescription.

This development is a very welcome step forward for people with diabetes, especially to people who have lost their warnings symptoms of low blood glucose levels so putting them at risk of coma. However, it is important that an overzealous approach to the advantages does not obscure the necessary warnings and precautions associated with this device.

Information about the GlucoWatch Biographer can be found by visiting their website: www.glucowatch.com

Cygnus have now closed their UK office and previous 0800 support lines will be directed to the US office.

The ALERT is because a random generation of a ‘Y’ shaped non-numerical character can appear in the test results display and may lead to inappropriate treatment.

RECOMMENDED IMMEDIATE ACTION

· All users of PocketScan meters should contact the LifeScan customer careline immediately to arrange for a replacement meter. Even if the ‘Y’ character has not been displayed, users must register for a replacement meter. The telephone number is freephone 0800 121 200

· Do not make diabetes treatment decisions on the basis of a result that includes a ‘Y’ shaped character.

· If there is any concern about treatment, the user must contact their healthcare provider.MEDIATE ACTION

1. The Medical Devices Agency has been informed that a software error has led to the random generation of a ‘Y’ shaped character in the display of PocketScan Meters.

2. The ‘Y’ shaped character is only displayed when the meter is in the mmol/l mode – the unit used in the UK.

3. LifeScan has begun a communication campaign in order to alert users of this problems and test strip packs now have a yellow notice sticker on them to alert users to the new information leaflet inside.

4. LifeScan have been unable to contact the majority of users since only a very small percentage of users have registered with the manufacturer.

5. The PocketScan meter is also marketed in other countries under the following names: FastTake, EuroFlash and SmartScan.

Safety warnings for users of Disetronic pumps

14 March 2001

Important safety information regarding use of the H-TRON or H-TRONplus insulin pump in contact with water

The safe use and reliability of Disetronic's products is our highest priority. Therefore, we ask that you read this letter and supplement carefully. A few pump wearers have reported experiencing hypoglycemic episodes (low blood sugar) after swimming or bathing, and some sought medical care. They also reported in such cases that their pump had apparently delivered more insulin than was programmed. Analysis of the insulin pumps returned to us revealed that water had entered the pumps. The source of the water entry was determined to be cracks in the pump housing or other leaks where water was able to get into the electronic compartment.

In response to these reports, Disetronic has researched the issues and performed tests on similar pumps. Disetronic damaged pumps to a comparable degree and put them in water to observe their behavior. The security system of each of the pumps tested signaled an alarm (ERROR 7) as expected and immediately placed the pump in the "STOP" mode, as designed. At this point, testing has not been able to duplicate the reported events.

However, for now, we ask that you follow these new instructions to help assure safe use of the pump with regard to contact with water:

· When changing a battery, check that the black "O" rings are correctly installed and seat properly

· Read and follow the enclosed supplement to the Reference Manual and place it with your Reference Manual

Disetronic is continuing to investigate, and will update you when new information becomes available on this topic. With the exception of these instructions with regard to the use of your pump in water, you can continue to experience the benefits of insulin pump therapy provided by your H-TRON or H-TRONplus insulin pump.

We apologize for any inconvenience these new guidelines may cause you, and we thank you for your support and the confidence you have shown in our products. We would be happy to answer any questions you may have. You can request a call from your local Disetronic representative and view the answers to frequently asked questions about this topic on our web site at www.disetronic-usa.com. You may also call us toll free at 1-877-852-8661 from 8:00 a.m. to 5:00 p.m. Central Standard Time.

Warnings about Human insulin from manufacturers, Novo Nordisk and Aventis

Jenny Hirst, Co-Chairman

July 7 2000

In September 1999 Novo Nordisk, one of the three major suppliers of insulin in the world, issued a press statement that included the following:

"Historically, improving glycaemic control with soluble human insulin has been associated with an increased risk of hypoglycaemia."

But of even greater concern is a statement from Aventis, another large insulin manufacturer, dated April 24^th 2000 that includes the following:

"Human insulin therapy may be associated with hypoglycaemia, worsening of diabetic retinopathy, lipodystrophy, skin reactions (such as injection-site reaction, pruritus, and rash), allergic reactions, sodium retention and oedema."

The statements were put in the public domain by the insulin manufacturers and not by IDDT. They cause us concern because the adverse reactions that may occur with ‘human’ insulin therapy, as listed by Aventis and Novo Nordisk, are very much in line with the evidence from a large number of patients in various countries. These reactions largely regress with a change to animal insulins.

IDDT contacted Health Ministers and the Regulatory Bodies within the Department of Health - May 5^th 2000

As a result of the above statements, we once again contacted the Department of Health [DoH]. We requested that the position in relation to ‘human’ and animal insulin is investigated by the Department so that people with diabetes may now given the full facts and evidence on which to base the choice of insulin species. In addition we asked that they consider the implications of these statements for Health Care Professionals. Our concerns appeared to be well justified by the publication of an article in Pulse, May 20th, quoting a helpful statement by the Medical Defence Union:

"The data sheets for human insulin specify the potential for lowered hypoglycaemia awareness but doctors should take care to discuss this with their patients." They further explain that provided they do this (and the patient is happy with this) any litigation would not be directed at them.

We made the Department aware of IDDT’s commitment to provide information about risks, benefits and alternatives to enable people with diabetes to make informed choices about their treatment. We pointed out that:

· IDDT has tried never to cause alarm or panic about the problems we know exist for a so far unidentifiable sub-group of people using ‘human’ insulin, but that we have a duty and commitment to people with diabetes.

· Our approach to this latest information has to be the same. We have to make this information available to people with diabetes through our Newsletter to be published July1st, our web site and other methods, otherwise we are guilty of withholding information that could affect the health and welfare of our client group.

· We are aware that it may, not unjustifiably, cause alarm as visual impairment and blindness are major fears for people with diabetes. We are equally aware that there may well be a desire on the part of some people to change to natural animal insulins.

We had hoped that the Department of Health would be able to make some response or guidance prior to publication of our Newsletter so that doctors and healthcare professionals would be prepared for any patients wishing to discuss or reconsider their insulin treatment options. However, some two months later the DoH has still made no response at all and therefore IDDT issued notices to consultants, GPs with a special interest in diabetes, diabetes specialist nurses and pharmacists.

It is 18 years since ‘human’ insulin was introduced there is still no evidence of any clinical benefit for patients and considerable evidence of adverse reactions. With the reservation that the decisions to prescribe ‘human’ insulin and to change people from the animal insulin that suited them were not, and still are not evidence based, IDDT has always fully acknowledged that the vast majority of people with diabetes appear to be satisfactorily treated with ‘human’ insulin. However, these public statements now made by two manufacturers of ‘human’ insulin have very serious implications for everyone treated with ‘human’ insulin and for prescribing doctors.

No such statements have had to be issued about either bovine or porcine insulins. It may be that these adverse reactions are as a result of increased hypoglycaemia and reduction in hypoglycaemia awareness, the most frequently reported adverse reactions by people using ‘human’ insulin, but this remains unknown. Our attempts to obtain information from Aventis have received no response. However, it now appears that the risk/benefit ratio for first line treatment may have shifted from ‘human’ insulin in favour of animal insulin and that the present prescribing habits may be putting some people with diabetes at risk of unnecessary and avoidable complications to which they are already susceptible.

Hypoglycaemia is an acute daily problem for those living with diabetes especially when accompanied by loss of warnings and any increased risks of this not only make ‘human’ insulin therapy less safe but reduce the quality of life of those with diabetes and that of their families. Hypoglycaemia may also cause all the adverse reactions quoted in the Aventis statements. Recent statistics show that between 4 and 13% of deaths in people with diabetes are now caused by hypoglycaemia.

The ‘worsening of retinopathy’ is an example of how serious these problems are. The implication of the wording is that for patients who already have retinopathy, ‘human’ insulin therapy could make it worse so leading to earlier visual impairment or blindness. While there are screening programmes for retinopathy, these and other services for people with diabetes, are very variable. Many patients have early retinopathy of which they are unaware because there are no signs or symptoms and many have early retinopathy at diagnosis. As there is no way of knowing which patients have retinopathy in its various forms, all patients may be at risk of worsening of retinopathy if ‘human’ insulin is prescribed. However small this increased risk may be, the risk of visual impairment and blindness is one that most people would consider unacceptable especially when there are alternative insulins that have never been said to carry such risks.

Oedema is an equally serious adverse reaction and now explains the large weight increase that happens to some people when they use ‘human’ insulin with the subsequent weight loss on changing to animal insulin.

IDDT remains committed to ensuring that the adverse reactions that some people experience with ‘human’ insulin are fully recognised and that their health and well being is not put at risk by the discontinuation of the animal insulins they need. We remain committed to the view that there is a need for research so that insulin treatment is based on evidence of benefit rather than assumption of benefit. No large-scale, long-term trials comparing ‘human’ and animal insulins, have ever been carried out and to assume that absence of evidence of adverse reactions is the same as evidence of absence of them is unacceptable to people with diabetes.

The Medicines Control Agency has issued a warning to doctors and pharmacists to be vigilant to the possibility of mis-prescribing or incorrect dispensing of products marketed under the Humalog name. Currently 6 such products are marketed in the UK.

Since April 1999, 7 patients have been prescribed or have received either Humalog

or Humalog Mix 25 in error. In the majority of instances the mistake resulted in

hospital admission. In July 1999, pharmacists in the UK were alerted to the problem in a letter sent by the manufacturer, Eli Lilly.

Lilly is currently modifying the packaging of these products throughout their world markets, labelling being differentiated by the redesign of the carton layout and additional use of symbols. Although it is anticipated that the new packaging should prevent further errors from occurring, awareness of this issue is important.

Note –This warning was only issued to pharmacists and doctors, not to patients, but remember that you should always check that you have been given the correct insulin before preferably before leaving the pharmacy.

Withdrawal of Pork Velosulin

Caution notice issued by IDDT

· The two insulins are NOT the same - the pork insulin is the same but the formulation is different. Velosulin contains a phosphate buffer and this is not present in Actrapid.

· Novo Nordisk have still not given any guarantees of their intention to continue production of animal insulins and this change is further rationalisation of their range of animal insulin products

· Patients using a pump will not be able to use Actrapid because of the absence of the phosphate buffer.

The only Actrapid available in the UK has been 'human' and this change is likely to lead to confusion for patients, doctors and pharmacists. An inadvertent switch to 'human' insulin could be potentially dangerous.

Novo Nordisk have offered no guarantees of future supplies of Pork Actrapid, withdrawal of this insulin could mean that people using it could be forced to have two changes a short period.

· People who are now using animal insulins are doing so because they have made a positive decision to do so and there is certainly no advantage in trying to convert them to 'human' insulin.

· Hypurin Porcine Neutral [short acting] made by CP Pharmaceuticals Ltd, does contain the phosphate buffer and hence appears to be the nearest match to Pork Velosulin and seems the logical insulin choice. Hypurin Isophane [intermediate acting] is also produced by CP.

· Changing brand of insulin will avoid any confusion which could arise over the similarity in the names of the Novo Nordisk 'human' and porcine insulins.

· Hypurin Porcine insulin is also produced in cartridges for use with pen injection devices unlike the Novo Nordisk pork insulins.

IDDT has numbers of patients who have happily changed from the Novo Nordisk insulins to CP Pharmaceutical insulins.

Note – this notice was sent to all IDDT members, 400 diabetes specialist nurses, all pharmacies and GPs in the UK.