Two new studies pointing out potential side effects of certain osteoporosis drugs may affect patient perception of these medicines. But is it really time to worry?
Specifically, bisphosphonates are designed to decrease the breakdown of bone by increasing bone density. While this staves off osteoporosis, problems can occur if the bone gets too dense. If bone gets much denser than normal, it may crowd out bone marrow, which contains the fat and tissue that make blood cells and stimulates bone healing. Higher bone density means less marrow, which in turn means the bone has less of a blood supply and is less able to heal.
But as troubling as osteonecrosis sounds, so, too, is osteoporosis. The National Institutes of Health reports that osteoporosis currently affects nearly 10 million Americans. Additionally, 34 million may be at risk for developing the disease, which is associated with brittle bones and a subsequent increased risk of often debilitating fractures.
The studies released Wednesday and Thursday are not the first that Fosamax -- which also goes by the generic name alendronate -- has weathered in its 13-year existence. Most recently, a study published in April in the Archives of Internal Medicine found that patients taking Fosamax had about an 86 percent increased risk for developing an irregular heartbeat. The study received widespread media attention, despite the fact that much larger studies largely exonerated Fosamax with regard to this side effect.
A statement issued Wednesday by Merck suggested that the latest study suggesting a higher-than-expected jaw osteonecrosis risk is likewise trumped by larger, more thorough studies that have already been performed.
"The study ... has material methodological flaws and scientific limitations, making it unreliable as a source for valid scientific conclusions regarding the prevalence of [osteonecrosis of the jaw] in patients taking alendronate," the statement reads. "In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years' data with alendronate, there have been no reports of [osteonecrosis of the jaw]."
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