FDA Bisphosphonate Safety Update
November 14, 2008
An FDA update released yesterday says clinical trial data from four drug makers shows little overall risk of heart problems in patients taking bisphosphonates, a class of drugs prescribed to prevent and treat osteoporosis. The agency reviewed studies on the following bisphosphonates:
- Merck & Co.’s Fosamax
- Roche Holding AG’s Boniva
- Novartis AG’s Reclast
- Procter & Gamble Co.’s Actonel
On the other hand, the FDA also said it was aware of other studies with conflicting findings and was considering whether to conduct further studies to investigate the risk of heart problems associated with bisphosphonates.
Concern over the safety of bisphosphonates surfaced in October 2007 when a study published in the New England Journal of Medicine reported incidents of serious atrial fibrillation, a type of abnormal heartbeat, in some women taking bisphosphonates. In response to the study, the FDA began looking into reports of abnormal heartbeats in women taking the drug.
Over the past two years, the FDA has collected data on nearly 40,000 patients, of whom 19,687 given a bisphosphonate and 18,358 given a placebo. In clinical trials, these patients were studied for between six months and three years. Within each study, the occurrence of atrial fibrillation was rare, with most studies containing 2 or fewer events.
In its update yesterday, the FDA wrote, “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.”
Although the FDA plans to continue to monitor possible heart problems in patients taking bisphosphonates, it concluded that, “… healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication” at this time.
Bisphosphonates Side Effects Lawyer
If taking a bisphosphonate, such as Fosamax, Actonel or Boniva, caused you to develop atrial fibrillation or other serious health problems, you have the legal right to file a lawsuit to seek compensation for your injuries. With a bisphosphonate lawsuit, patients injured by bisphosphonates may be able to recover compensation for medical expense, lost income, pain and suffering, and possibly more.
Contact us today to learn more about bisphosphonate lawsuits and your legal rights.