Sun, Jul 05, 2009

Washington

Review finds bone drugs don't cause heart flutters

Bloomberg News
Tucson, Arizona | Published: 11.13.2008
A government review of bone- strengthening drugs found no reason for people to stop taking the medications, among them Merck & Co.'s Fosamax, that some studies have linked to irregular heart rhythms.
The Food and Drug Administration examined the group of osteoporosis treatments known as bisphosphonates for an association with atrial fibrillation, or heart flutters, according to a notice Wednesday on the agency's Web site.
The condition can cause dizziness, fainting and fatigue, and in some cases lead to heart failure or strokes.
The group of seven types of bisphosphonates approved by the FDA includes Fosamax, Roche Holding AG's Boniva, Procter & Gamble Co.'s Actonel and Didronel, Novartis AG's Aredia and Reclast, and Sanofi-Aventis SA's Skelid. The agency announced the review just more than a year ago after a study in the New England Journal of Medicine raised the concern.
"Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed," the agency said. At the same time, the FDA said it may conduct further studies because of "discordant results from the literature."
Osteoporosis, or thinning bones, is the most common bone disease. Women older than 50 and men whose testosterone levels have declined are the most vulnerable.
Drugs for the condition had worldwide sales of $9 billion last year, according to market research firm IMS Health Inc. Fosamax was the top seller, bringing in $3 billion last year.