EMA wants Actos warning, weighs in on Chantix
Regulators on both sides of the Atlantic issued a slew of decrees about drug safety, weighing in on everything from flu vaccine to bone drugs to Pfizer's smoking cessation med Chantix. The biggest decision came from the Europeans, which decided to leave the Takeda diabetes drug Actos on the market, but added strong warnings about possible links to bladder cancer.
France and Germany have both halted sales of Actos, which belongs to the same class of diabetes remedies as the GlaxoSmithKline drug Avandia. While the European Medicines Agency decided to withdraw Avandia on its cardiovascular risks, it won't restrict use of Actos, which has been tagged with increasing the risk of bladder cancer. The risk could be minimized by proper patient selection, the EMA said. FDA recently added new cautionary language to the drug's label about the possible cancer link.
FDA, for its part, reported on an ongoing review of bone drugs known as bisphosphonates; the agency has been looking at some conflicting studies of the drugs' potential links to esophageal cancer. For now, the agency said, the benefits appear to outweigh the risks, but an FDA advisory panel will be discussing their safety at a meeting in September. The class includes such popular meds as Merck's Fosamax and Roche's Boniva.
Meanwhile, an EMA committee said it had determined that Chantix's benefits outweigh its risks. New questions about the drug were raised by a meta-analysis that found an increase in cardiovascular problems, such as heart attack and stroke, in patients using the drug. The EMA's Committee for Medicinal Products for Human Use found some weaknesses in that analysis, including the exclusion of studies in which no patient experienced a cardiovascular event, Pharmalot reports.
Finally, the EMA wants GlaxoSmithKline to update its label on the pandemic flu shot Pandemrix, after finding a link between its use in young people and the rare sleeping disorder narcolepsy. The agency said the CHMP has recommended that people under 20 should avoid Pandemrix unless they have no access to seasonal flu vaccines and they're at high risk of complications from H1N1.
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