Can an anti-smoking drug be injurious to health? Pharma giant GlaxoSmithKline (GSK), under fire regarding its smoking cessation drug, Zyban, has risen in defence of its non-nicotine oral drug - in the wake of unproven reports in the UK, linking the drug to adverse reactions and deaths.
Touted to be the world's most successful smoking cessation drug, Zyban received a high decibel launch in India in June 2001. The cause for concern, however, was a safety update on the site of British regulatory body, Medicines Control Agency (MCA). The update, suggesting an unproven association between the tobacco-cessation drug and 57 deaths in the UK, spurred media-reports abroad casting a cloud over Zyban and subsequently causing a ripple effect in domestic circles.
Mr Kal Sundaram, GSK's Director-Pharmaceuticals, told that regulatory bodies such as MCA of the UK and the FDA of the US have celared the drug and have said that "there were no reports directly linking the deaths to Zyban". Zyban is a prescription drug and GSK would continue to sell it across world markets, he said. Endorsing the safety profile of Zyban, GSK said: "Death (the 57 reported deaths) was most commonly due to cardiovascular causes and where information on medical history was provided, most patients had a history of cardiovascular disease or risk factors for cardiovascular disease in addition to smoking."
According to GSK reports in the UK, sales had slumped 34 per cent to 22 million pounds ($31 million) in the three months between October to September last year following media coverage of the reported deaths. Zyban, when launched, had come with its cautions saying: "For majority of smokers, side effects of Zyban are not a concern. Zyban is generally well tolerated. Side effects are mild and include dry mouth and insomnia.....should be used cautiously, if at all, in patients with seizure disorder and in those taking alcohol during treatment."