The U.S. Food and Drug Administration has warned doctors and patients about an increased risk of thigh fractures with a widely-used group of bone-strengthening drugs. The agency said patients taking bisphosphonate drugs such as Fosamax and Boniva appear more likely to suffer a rare type of fracture of the femur. The fractures occurred just below the hip joint and make up less than 1% of all femur fractures.
In more than half the cases reported to the FDA, patients experienced pain or aching of the groin before the fracture. The FDA is updating the drugs’ labels about the fracture risk. Drugmakers will also be required to distribute pamphlets about the risks to patients. Bisphosphonates work by slowing the loss of bone cells that lead to osteoporosis. Prescription drugs in that class include Merck & Co.’s Fosamax and Roche’s Boniva, as well as Warner Chilcott’s Actonel and Atelvia and Novartis’ Reclast. More than 5 million prescriptions for the drugs were written last year, according to the FDA. The drugs are mainly prescribed to women after menopause. The FDA says patients should continue taking the treatments unless directed to stop by their doctor. The agency said it will continue reviewing safety information on the drugs and eventually make recommendations on their use.
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