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FDA Looks into Possible Fosamax Connection to Jaw Problems and Leg Fractures

The United States Food and Drug Administration will form an advisory committee to discuss the benefits of long-term biphosphonate use for the treatment of osteoporosis. Biphosponates include Fosamax and Fosamax D, made by Merck & Co.; Actonel, Atelvia, and Actonel with Calcium, manufactured by Warner Chilcott; Boniva, made by Roche Therapeutics; Reclast, made by Novartis Pharmaceuticals Corp.; and the generic equivalents for these products. Drug companies like Merck, the maker of Fosamax, have been receiving more lawsuits alleging that people who have taken the drug have suffered from leg fractures and osteonecrosis of the jaw. According to the National Institutes of Health, osteonecrosis occurs when blood flow to a bone is insufficient. When the bone does not get enough blood, it dies. The bone itself can actually collapse.

Further Regulatory Action by the FDA

These committees are usually set up by the FDA to obtain input from the public on drug use and safety issues. Further regulatory action by the FDA could be in the future. The meeting is scheduled for September 9, 2011, at the Marriott Inn and Conference Center in Adelphi, Maryland. The public is allowed to present information orally or in writing to the committee. Written submissions are required before August 25, 2011. Interested persons can speak to the board and submit oral presentations from 1 to 2:00 p.m. on September 9, 2011. Anyone wishing to address the board on September 9 should submit a brief statement of the arguments and evidence they expect to present, along with the names and addresses of all who will be participating on or before August 17, 2001. If there are more people who would like to speak than time available, speakers will be assigned by a lottery.

Further information about the meeting can be obtained at Kalyani Bhatt Center for Drug Evaluation and Research Food and Drug Administration, 10901 New Hampshire Avenue W031-2417, Silver Spring, MD 20993-0002; phone: 301-796-9001; fax: 301-847-8533; e-mail: [email protected]; or the FDA Advisory Committee Information Line at 800-741-8138 (301-443-0572 in Washington, D.C., area). Call the Information Line for up-to-date information on the meeting. Further information can be found at the FDA's website at fda.gov.

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