FDA Conducts Heart-Safety Review of Bone-Building Drugs

posted on:
October 1, 2007

author:
Staff

Washington-(Dow Jones)- The Food and Drug Administration said Monday it's conducting a safety review of bone-building drugs to see if there's a link to atrial fibrillation, a heart rhythm disorder.

The FDA said the review was prompted by an article in the New England Journal of Medicine's May 3 edition that suggested an increased rate of serious atrial fibrillation in older women treated with Reclast, made by Novartis AG (NVS), and Fosamax, by Merck & Co. (MRK).

The drugs fall into a class of medicines known as bisphosphonates, often used to increase bone mass in order to treat osteoporosis. The drugs are also used to treat other bone diseases as well as certain cancer patients.

The FDA said it's reviewed a database of post-marketing safety reports involving the drugs and reports of atrial fibrillation, and "did not identify a population of bisphosphonate users at increased risk of atrial fibrillation." The agency noted that the condition is common among people age 65 and older, which is the same age range as the patients in the New England of Journal article.

The FDA said it looked at the issue as part of its review for Reclast, a once- yearly injection, which was approved in August. The FDA said it found that reported cases of atrial fibrillation occurred more than a month after drug infusion, suggesting the drug likely didn't play a role. The agency also said among a subset of patients who were monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

For now, the agency said it "does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time."

The FDA said it has requested additional information in order to conduct a more in-depth safety review of the drugs and possible links to atrial fibrillation. The agency said the review could take up to 12 months.

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