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Osteoporosis Drugs: Risk to the Heart?

Fosamax, Other Bisphosphonate Drugs Studied; No Reason to Stop Use, Experts Say

Real Risk or Fluke?

WebMD asked two independent experts to review Heckbert's study.

"The evidence here is interesting, but I'm not going to put this at a high level of confidence at this point," Edward Puzas, MD, tells WebMD. Puzas is a professor of orthopaedics, director of the Osteoporosis Center, and director of orthopaedic research at the University of Rochester School of Medicine in Rochester, N.Y.

"I think you're going to see articles coming out on both sides of this right now, and my prediction is that in the end, it's going to sort itself out that there's little if any risk associated with cardiovascular issues and these bisphosphonates," Puzas says.

"I'm not ready to believe that the bisphosphonates, certainly as a class, have got any real potential serious adverse event with regard to atrial fibrillation," Puzas says. "Sometimes, where there's smoke there's fire, but many times, when you retrospectively ... look at these articles, they really do amount to statistical fluke or a statistical fluctuation, and it's not until other people demonstrate them in other trials in a more prospective, rigorous fashion that you can actually believe the evidence.

"If I were treating a new patient and about to put them on a bisphosphonate, I would evaluate their cardiac status with an extra eye toward looking at atrial fibrillation," says Puzas, adding that he wouldn't rule out bisphosphonates based only on cardiovascular risk factors.

Henrik Toft Sorensen, MD, PhD, who worked on the Danish study published by BMJ (formerly called the British Medical Journal) in April 2008, notes that Heckbert's data "might be vulnerable" to factors not weighed by the researchers. "This study does not change my recommendations for treatment. More data are needed," Sorensen tells WebMD by email.

An editorial published in the Archives of Internal Medicine praises Heckbert's study. But like Heckbert, Puzas, Sorensen, and the FDA, the editorialists don't jump to conclusions about bisphosphonates and atrial fibrillation.

Drug Companies Respond

WebMD contacted Merck, the drug company that makes Fosamax, for its response to Heckbert's study.

In a statement emailed to WebMD, Merck notes that randomized clinical trials are "the gold standard" for evaluating drug safety and efficacy, and Heckbert's study was an observational study, not a randomized clinical trial. "We strongly recommend that if patients have concerns about Fosamax that they talk to their physician," states Merck, adding that "it's worth pointing out that authors of the editorial in the Archives of Internal Medicine conclude: 'At this time, it seems that the benefits of bisphosphonate treatment in patients with osteoporosis outweigh the risks of [atrial fibrillation].'"

Reclast is made by the drug company Novartis. In May 2007, when The New England Journal of Medicine published the results of the Novartis-sponsored Reclast clinical trial, Novartis issued a news release stating that though 1.3% of the Reclast patients in the trial developed atrial fibrillation, compared to 0.5% of those taking placebo, those findings didn't appear in other studies. Novartis also noted that Reclast's active ingredient, zoledronic acid, has been used by more than 1.5 million cancer patients, with no sign of increased risk of atrial fibrillation.

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