The US Food and Drug Administration has published its quarterly report on treatments where the agency has identified a potential safety risk.
Among the high-profile drugs that the FDA has identified through its adverse event reporting system (covering October to December 2008), are Pfizer’s overactive bladder treatment Detrol (tolterodine) and smoking cessation drug Chantix (varenicline), Roche’s weight loss drug Xenical (orlistat) and GlaxoSmithKline’s over-the-counter version of the drug Alli. Also included on the list are Merck & Co’s HIV drug Isentress (raltegravir) and Cephalon’s sleep disorder treatments Nuvigil (armodafinil) and Provigil (modafinil).
The FDA stresses that the appearance of a drug on this list, which contains some 20 treatments, does not mean that the agency has concluded that the therapy has the listed risk. The agency also emphasises that it is not suggesting that doctors should stop prescribing the drug or that patients should quit taking the medication.
Chantix is under review due to reports of serious skin reactions, visual impairment, angioedema and accidental injury in patients taking the drug, while Detrol is being investigated for a possible link to the skin condition Stevens-Johnson syndrome. Provigil and Nuvigil are also under review for serious skin reactions. As for orlistat, the FDA is investigating a potential hepatotoxicity link.
