UK Issues Tougher Warnings on Zyban
I must admit, this is the first I’ve heard of these warnings with the use of Zyban. This is tough ground to tread on. It’s always easy to beat up on pharmaceutical drugs (sometimes too easy!!), but in this case it’s difficult. When Zyban is used along with the patch for smoking cessation, the effectiveness just markedly. So, we have a potential short term therapy that effectively helps many smokers quit; lowering the risk of many diseases that smoking contributes to. Dangerous side effects do complicate the issue and patients need to be fully informed. I know there are natural alternatives to smoking cessation, but I am unfamiliar with any in my practice.
(article) Tougher warnings for physicians prescribing GlaxoSmithKline’s smoking cessation drug Zyban (bupropion) were announced on Thursday by the UK’s Committee on Safety of Medicines (CSM). Bupropion is also marketed under the tradename Wellbutrin as an anti-depressive agent. In a statement, the CSM said existing warnings for prescribers relating to risk factors for seizures should be strengthened to emphasize that Zyban should only be used in patients with these factors if there are compelling clinical reasons. The CSM added that the prescribing regime should be amended to delay the increase in dose from day 4 to day 7 of treatment to give more time for drug levels to stabilize. Over 5000 adverse reports have been received for Zyban of which 40 have been associated with a fatal outcome, the statement said. “At least 419,000 patients are estimated to have used Zyban. About 2% of adverse reports for all medicines are associated with a fatal outcome. For Zyban, the proportion of reports that is fatal is much lower — less than 1%. The CSM considers that the reports received are in line with the known safety profile of Zyban.” Last month, British coroner Alan Lawson called for improved warnings to ensure patients do not take the drug with certain other medications which can potentiate the effect of Zyban. His comments came as he recorded a verdict of death by natural causes on airline flight attendant Kerry Weston, 21, of Broxbourne, Herts who was found dead in her hotel room in Nairobi a fortnight after she was prescribed Zyban. The court heard she was also taking chloroquine and sleeping pills. Thursday’s statement from the CSM says patients who are considering taking Zyban should tell their doctor if they have ever had a convulsion or unexplained blackout. It also makes clear that there are certain medicines and medical conditions that require reducing the dose of Zyban. The statement says patients should tell their doctor or pharmacist about past head injuries, insulin-dependent diabetes, and heavy drinking. Patients should also tell prescribers if they are taking any of the following: anti-malarial medicines (such as chloroquine or proguanil); certain antihistamines, some of which may be used for sleep problems; antidepressive agents or other psychotropic drugs (such as clozapine, risperidone or thioridazine); theophylline; steroids; certain antibiotics (for example, ofloxacin, levofloxacin or norfloxacin); tramadol; slimming medicines or other stimulants.