FDA Adds New Information to Fosamax Label: Consumers May be at Risk of Atypical Bone Fractures

On October, 2010, the Food and Drug Administration (FDA) announced new information would be added to the Warnings and Precautions section of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis, including Fosamax.

The warning came after new studies suggested the drug, manufactured by Merck & Co. and commonly used for the treatment of osteoporosis in postmenopausal women, may be linked to unusual fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures.

But the concerns surrounding Fosamax do not end here. Reports indicate the drug also causes Osteonecrosis , a disfiguring condition caused by the rotting of the jaw. Indeed, for the last five years, Merck & Co. has had to defend a flood of lawsuits filed by osteonecrosis victims.

Severe digestive reactions, including nausea, heartburn, stomach pain, diarrhea, and muscle cramps, blood clotting disorders, numbness and seizures are among Fosamax’s other side effects.

The FDA approved Fosamax in 1995, after medical trials demonstrated the drug’s efficacy substantially outweighed its then reportedly mild side effects. Today, however, the risks associated with Fosamax are many, and to keep patients informed, the FDA is requiring that all physicians hand their patients a medication guide explaining recent findings about Fosamax’s side effects.

For more information about Fosamax and any preventive measures visit Drugs.com

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