Merck Says Trial Data Show No Link Between Fosamax, Cardiovascular Events

Merck has released a new analysis of 28 clinical trials that the company said shows no direct link between Fosamax and increased incidence of adverse atrial fibrillation events.

Merck submitted data from the reanalysis to the FDA as part of the agency’s ongoing review for the safety of bisphosphonates, which typically are used to treat osteoporosis. The review could take until October 2008, according to the agency.

A study in the May 3 issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Merck’s Fosamax (alendronate sodium) and Novartis’ Reclast (zoledronic acid).

However, according to Merck, the risk of atrial fibrillation in the trial was similar between Fosamax and placebo. The FDA has not recommended that healthcare professionals change their prescribing habits of bisphosphonates or that patients change their use of the drugs.

More information on the FDA’s early communication about bisphosphonates can be seen at www.fda.gov/cder/drug/early_comm/bisphosphonates.htm.