FDA Panel to Discuss Long-Term Use of Fosamax, other Bone Drugs

A U.S. Food & Drug Administration (FDA) advisory panel is set to examine the safety of <"http://www.yourlawyer.com/topics/overview/Bisphosphonates">oral bisphosphonates later this week. The FDA advisory panel meeting, set to start of Friday, is being convened because of concerns that long-term use of oral bisphosphonates might be associated with serious side effects, including a rare and serious type of thigh fracture.

Oral bisphosphonates include the medications <"http://www.yourlawyer.com/topics/overview/fosamax">Fosamax, Actonel, and Boniva. The drugs are mostly prescribed to treat or prevent osteoporosis in post-menopausal women. According to the FDA, approximately 5 million Americans use oral bisphosphonates.

Last year, the FDA added information to the “Warnings and Precautions” section of the drugs’ labels describing the risk of atypical thigh fractures. As we reported previously, there have been at least 300 reports of atypical thigh fractures in patients taking the drugs, often for longer than five year.

According to The Wall Street Journal, the FDA advisory panel will consider whether women taking oral should go on a “drug holiday” or temporary break, or if the use of oral bisphosphonates should be limited to a few years. Most research on the drugs has covered three to five years of use, but many women take them indefinitely.

Women who’ve taken bisphosphonates for longer periods are “all guinea pigs,” Dr. Susan Ott, author of a review of the drugs, told the New York Times. “The longest anybody could have taken this drug is 15 years now,” said Ott, who uses the drugs in her own patients for shorter periods. “It’s an ongoing experiment, and there are a few million women in the country who are participating in it.”

The possible association between oral bisphosphonates and femur fractures has sparked a wave of product liability litigation against Merck & Co., the maker of Fosamax, which was the first such drug to come to market. In May, scores of Fosamax thigh fracture lawsuits were consolidated in a multidistrict litigation and transferred to the U.S. District Court for the District of New Jersey for pretrial proceedings.

Thigh fractures aren’t the only serious side effects associated with the use of oral bisphosphonates. In 2005, the FDA ordered that the labels for bisphosphonates be updated to include warnings about osteonecrosis of the jaw, a condition also known as dead jaw syndrome.

Earlier this summer, the FDA also announced that it was continuing a review to determine if oral bisphosphonates were associated with a greater risk of esophageal cancer. In a Drug Safety Communication issued in July, the agency said that so far, evidence of this risk is inconclusive and that larger studies of the drugs may be needed.

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