US drugs giant Merck & Co (NYSE: MRK) says that a federal court jury in New York found in its favor in the Secrest v Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her use of the firm’s bisphosphonates osteoporosis drug Fosamax (alendronate).
Last month, a joint meeting of the US Food and Drug Administration’s Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee discussed the benefits and risks of long-term bisphosphonate use in light of the emergence of the safety concerns of osteonecrosis of the jaw (jawbone death) and atypical femur fractures (unusual broken thigh bone) that may be associated with the long-term treatment with these drugs (The Pharma Letter September 12). However, the panelists said there is not enough data to make recommendations about whether the use of this widely prescribed class of drugs for osteoporosis should be limited, though advised new labeling.
“We believe the company acted properly,” said Chilton Varner of King & Spalding, outside counsel for Merck, noting: “Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking Fosamax. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body’s ability to heal.”
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