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FDA Panels Advise Label Clarification to Prevent Fosamax Side Effects

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Washington, DCTwo advisory panels to the US Food and Drug Administration recently recommended that in order to prevent more instances of dangerous Fosamax side effects, the label for the drug and other similar medications should become more clear.

According to The New York Times, while the FDA panels suggested improving the labels of bone-building drugs—which are taken by more than 5 million women in the US— they did not give specific details on what the labeling changes should entail.

The decision by the advisory panels to stop short of offering specific labeling recommendations follows a recent report from the federal agency itself, noting that studies "suggest no significant advantage of continuing drug therapy beyond five years," the news source reports.

The advisory panels reportedly came together after concerns arose from a number of patients who had suffered atypical thigh fractures or jaw disease after taking the bone drugs for an extended period of time. While the benefits of taking the drugs for three to five years have been demonstrated, they have not been proven for longer-term use, the FDA said.

Despite this, none of the panel members decided to recommend strict limitations on long-term use, with a black box warning also not suggested, despite the pleas of many former patients who reportedly suffered from the side effects.

The drugs include Actonel, Atelvia, Boniva and Fosamax, which is manufactured by Merck. According to Reuters, a number of lawsuits have been filed against Merck and are currently being heard.

Recently, a federal judge threw out a portion of a bellwether lawsuit against the drugmaker over claims that Fosamax can lead to the development of jaw damage, the news source said.

While District Judge John Keenan decided that plaintiff Linda Secrest can continue with her claim that the bone drug had a design defect that resulted in the death of her jaw tissue, he ruled that no reasonable jury would rule in the woman's favor over her allegation that the company did not sufficiently warn patients about the drug's health risks, according to the news provider.

According to Reuters, Merck has said that as of June 30, it had faced approximately 1,650 lawsuits related to claims about Fosamax side effects, including 910 different cases prior to the one in front of Judge Keenan.


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