Osteoporosis drugs 'do not lead to heart problems'

There is no overall risk of heart problems for patients taking bisphosphonates to treat osteoporosis, according to a review by the US Food and Drug Administration (FDA).

The agency launched the follow-up safety review following an article in The New England Journal of Medicine in May 2007, which raised concerns on the increased risk of serious atrial fibrillation in osteoporosis patients taking bisphosphonates.

From October 2007 onwards, the FDA began requesting data from sponsors of placebo-controlled clinical trials of alendronate, ibandronate, risedronate, and zoledronic acid in order to assess the risk of atrial fibrillation, an arrhythmia involving the two upper chambers of the heart.

Data submitted by the four sponsors, Merck, Roche, Novartis, and Proctor & Gamble, included 19,687 patients treated with bisphosphonates and 18,358 patients given placebo. In the original trials, participants received follow-ups for six months to three years.

The FDA review revealed that most studies contained two or fewer occurrences of atrial fibrillation, and "the absolute difference in event rates between each of the bisphosphonate and placebo arms varied from zero to three per 1,000".

However, the agency noted that one large clinical trial of zoledronic acid showed a significant increase in the rate of atrial fibrillation, but there was no clear association between bisphosphonate exposure and atrial fibrillation in any of the studies.

"After our review, based on the data available at this time, healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication," the FDA concluded.

A spokeswoman for the Arthritis Research Campaign welcomed the FDA's findings.

"Bisphosphonates are important in maintaining bone density in people with osteoporosis, and are generally well-tolerated and safe drugs," she added.

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