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FDA Investigates Fosamax While MDL Committee Reportedly Meets

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Newark, NJReports indicate that lawsuits alleging Fosamax side effects are going ahead, with an MDL steering committee set to meet. Lawsuits filed against the maker of Fosamax allege there is an association between the use of Fosamax and femur fractures, while previous lawsuits alleged patients suffered from Fosamax osteonecrosis of the jaw, with several of those lawsuits already being heard in court. Meanwhile, the FDA is now investigating a possible link between the use of Fosamax and the development of esophageal cancer.

According to reports, the multidistrict litigation steering committee, which coordinates the plaintiffs' activities during pre-trial proceedings—such as the discovery process—was recently formed by court order. Previously, a court order set out that 36 lawsuits filed against companies linked to Fosamax in a variety of federal districts be consolidated in a district court.

The lawsuits alleged that Fosamax use was linked to low-impact femur fractures and that Merck failed to adequately test the drug and failed to warn patients about the risks associated with the medication. In October 2010, the US Food and Drug Administration (FDA) issued a warning that use of bisphosphonates, a class of drug that includes Fosamax, were linked to an increased risk of rare low-impact femur fractures.

The courts have already heard lawsuits alleging that Fosamax caused osteonecrosis of the jaw in some patients, and at least some of those lawsuits were decided in favor of the defendant. One lawsuit was found in favor of the plaintiff, but a judge found the $8 million award excessive. The Wall Street Journal (02/07/11) notes that Merck faces approximately 900 cases related to Fosamax.

Meanwhile, the FDA announced that it is conducting an ongoing safety review of bisphosphonates, including Fosamax, to determine if they are linked to an increased risk of esophageal cancer. The decision to review bisphosphonates came after the FDA received data from two studies, one of which showed no increase in the risk of esophageal cancer but the second of which found double the risk in patients who had taken the drugs for more than three years or who had 10 or more prescriptions of the drugs.

At this time, the FDA considers the benefits of bisphosphonates to outweigh the risks and notes that esophageal cancer is rare. The agency recommends that patients follow specific directs for use of the medications.

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