FDA: No heart rhythm problem with bone building drugs

Washington, November 13: The U.S. Food and Drug Administration (FDA) said on Wednesday that the clinical trials from four leading drug manufactures - Merck’s Fosamax, Roche’s Boniva, Novartis’ Reclast and Zometa, and Procter & Gamble’s Actonel - shows no clear link between taking bone drugs called bisphosphonates and a heart-rhythm disorder called atrial fibrillationdefine (AF).

Atrial fibrillationdefine (AF) is an abnormal rhythm of the heart and the condition cause palpitations, shortness of breath, dizziness, fatigue and stroke. AF is increasingly common with advancing age.

In 2007, the FDA asked the drug companies to submit additional data to the agency after twin studies published in The New England Journal of Medicine, in the same year raised a concern. The studies warned of an increase in the rates of irregular heart beats in older women treated with Reclast, made by Novartis AG, and Fosamax, made by Merck & Co.

Since Oct. 2007, the FDA has collected data on 19,687 bisphosphonate treated patients and 18,358 placebo treated patients who were followed for periods ranging from six months to 3 years. The occurrence of heart-rhythm disorder was rare within each study, with most studies containing two or fewer events.

After reviewing the "multiple studies", the FDA stated that there is "no clear association between overall bisphosphonate exposure and the rate of serious or nonserious atrial fibrillation."

The drugs, part of a class of products known as bisphosphonates, are effective treatments for the prevention and treatment of osteoporosis. They are commonly used to increase the bone mass in order to treat osteoporosis and also treat other bone diseases as well as certain cancers.

The FDA said in a statement on its Web site, "After our review, based on the data available at this time, health-care professionals should not alter their prescribing patterns for bisphosphonates, and patients should not stop taking their bisphosphonate medication."

The seven other FDA approved bisphosphonates are, ibandronate (Boniva), risedronate (Actonel, Actonel W/Calcium), alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), zoledronic acid (Reclast, Zometa), pamidronate (Aredia), and tiludronate (Skelid).

Osteoporosis is a disease of the bones that leads to an increased risk of fracture and is one of the most common bone diseases. It is often called a silent disease because it does not cause any symptoms until a bone is broken. Women above 50s and men whose testosterone levels have declined are the most vulnerable.