Glaxo faces more problems

Already beset with many problems form drug regulators, one more problem was added to Glaxo Wellcome cup of woes, when a drug watchdog, the Medicines Control Agency, which monitors the safety of drugs sold in the UK, reported that seven users of its smoking cessation drug Zyban had suffered a stroke. While it has yet to be established that the drug caused the stroke since all the patients were in the high-risk smokers category, the news is bound to be a dampner to Glaxo’s sales.

Glaxo, whose merger with SmithKline Beecham has been delayed, stated that an estimated 15 million people have consumed the drug worldwide till date, and the company has no evidence of an increased risk of stroke associated with the use of this medicine. The company also said that there was no evidence of another anti-depressant drugh, Wellburtin, whose chemical composition was identical to that of Zyban, causing any stroke.

The MCA said that smokers concerned about the risk of strokes and side-effects of Zyban and other treatments should consult their doctors.

The MCA report comes at a time when the company is already beset with problems that have resulted in product and regulatory setbacks. The company’s merger with SmithKline Beecham, which was to have been completed by August, has already delayed twice by US regulators. The companies now hope to complete the transaction by end of this year.

Despite receiving some respite when US regulators cleared its treatment against Aids, Trizivir, Glaxo is set to face restrictions in the US on the number of people that can use Lotronex, its drug against irritable bowel syndrome. Relenza, its flu treatment, is also likely to be limited to some special groups by the UK authorities.