Zyban – Safety precautions from the Committee on Safety of Medicines

30 May 2002

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.

The CSM have issued warnings to doctors:

  • Changes in the recommended dose
  • 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.