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A red flag was raised last year on a class of drugs known as bisphosphonates, used to treat thinning bones from osteoporosis.
The FDA now says that clinical follow-up trials show no overall risk of heart problems associated with the drugs.
In an article in the May 2007, New England Journal of Medicine (NEJM), two different studies of women ages 65 to 89 with osteoporosis were treated with Reclast and Fosamax.
Data available to the FDA showed an increased risk of serious atrial fibrillation (AF). The Reclast label was changed to reflect the risk.
As a result of these findings, in October 2007, the FDA began collecting safety data on 40,000 patients. Half had been given a bisphosphonates and half a placebo. The patients were followed for six month to three years.
The occurrence of AF was rare with two or fewer events reported.
“Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Increasing dose or duration of bisphosphonate therapy was also not associated with an increased rate of atrial fibrillation,” according to the FDA in a release Wednesday.
The FDA now says that healthcare professionals should not alter their prescribing patterns for bisphosphonates.
The popular bisphosphonates are:
- Fosamax (alendronate) Merck & Co
- Didronel (etidronate) Procter and Gamble
- Boniva (ibandronate) Roche Holding AG
- Aredia (palidronate) Novartis
- Actonel (risedronate) Procter and Gamble
- Skelid (tiludronate) Sanofi Aventis
- Reclast, Zometa (zoledronic acid) Novartis
One large study of zoledronic acid showed a statistically significant increase in AF events, but it was not associated to the drug exposure or the duration of time on the drug. Reclast is the once yearly injectable bisphosphonate.
Still some questions linger about how this class of drugs affects the heart beat. The FDA has not ruled out additional epidemiologic studies on the issue.
Possible severe pain is already a recognized side effect among some taking the drugs.
Bisphosphonates work by slowing the bone turnover which normally occurs. The drug class is also used to treat patients with Paget’s disease of the bone and to treat bone metastases.
AF is not uncommon in individuals over the age of 65, the same age as many in the study last year.
During AF, the heart’s upper chambers quiver instead of beat. The heart stops pumping blood effectively and the risk raises for blood clots. 15 percent of strokes occur in people with AF.
Anyone who has had adverse side effects from this class of drugs is asked to report the use of bisphosphonates to the FDA MedWatch Adverse Event Reporting Program. #