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Thursday, October 14, 2010

FDA Issues Bone Drug Warning

The Food and Drug Administration issued a warning on Wednesday, Oct. 13, linking use of a popular osteoporosis drug with fracture of the thigh bone. The drugs, known as biophosphonates, are used around the world and have been heavily marketed drawing in as much as $8 billion.

Biophosphonates reportedly slow the loss of bone mass, and reduce the risk of hip or spine fractures in older women. Oral biophosphonates include Actonel, Atelvia, Boniva, and Fosamax, and injectible drugs include Boniva and Reclast.

The FDA has previously looked at the link between biophosphonates and jaw osteonecrosis, esophageal cancer, and arrhythmias. The bone breaks in the thigh are rare breaks known as a subtrochanteric femur fracture, which occurs just below the hip joint, and diaphyseal femur fractures occurring in the long part of the thigh.

The FDA says it has not proven that biophosphonates cause the fractures, but they show up in disproportionate levels among patients taking the drugs, especially in those who have been taking the drugs long term.

Genentech, which markets Boniva, is working closely with the FDA to add a statement about the bone fractures to the label. Merck, the drug maker of popular Fosamax, says they have not found an increase in fractures, but complied with the FDA in June 2009 to add the risk of thigh fractures to their label.

If you or a loved one has been injured from taking a biophosphonate, please contact the experienced defective product attorneys at the Cochran Firm. We serve clients nationwide.

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posted by Benjamin A. Irwin at 9:17 AM

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