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FDA Panel Calls for New Warnings on Bisphosphonates, But Not Specific Time Limits on Usage

Sep 12, 2011 | Parker Waichman LLP

A panel of outside medical experts was unable to recommend how long women can safely take oral bisphosphonates for osteoporosis, but did vote 17-6 that the U.S. Food & Drug Administration (FDA) update the drug's labels to “further clarify the duration of use."  The FDA is expected to update the labels for Fosamax, Actonel, Boniva and Reclast in November, and usually does abide by advisory panel recommendations, though it is not obligated to do so.

It's long been assumed that oral bisphosphonates could be safely taken indefinitely by post-menopausal women for the prevention and treatment of osteoporosis.  However, few studies have been conducted to assess the drugs' long-term risks.   On Friday, the FDA conducted a joint meeting of its Drug Safety and Risk Management Committee and the Advisory Committee for Reproductive Health Drugs to discuss the long-term risks of oral bisphosphonates.  In recent years, concerns have grown over their long-term risks, including their possible association with dead jaw syndrome, atypical femur fractures and esophageal cancer.

“The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting,” an FDA report released just two days before the study stated.   The same report also raised questions about the drugs' long-term effectiveness, finding that women who stop taking the drugs after five years experienced similar benefits to those who continued taking them.  While no benefit was seen in women who took the drugs for less than three years,  fewer broken bones from osteoporosis were seen in women who used them between three and five  years.

While the FDA panel agreed on the need for stronger warnings (though not the strongest Black Box warning), it left the wording of those warnings up to the agency.  None of the panel members recommended firm time limits for the drugs, citing a lack of data to "pinpoint an ideal therapeutic time limit."  The advisors also discussed the idea of patients being prescribed a “drug holiday", or a temporary break, from taking bisphosphonates to minimize their risks, but agreed there was not sufficient evidence to recommend that route.




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