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FDA calls for Fosamax warnings based on study
Monday, 13 March 2006
The Food and Drug Administration has announced that the osteonecrosis drug Fosamax and other drugs in its class should carry a warning about the jaw condition osteonecrosis of the jaw, or jaw necrosis. The call for warnings about the risk of Fosamax side effects was made as a result of a recent study highlighting the link between the drug and jaw necrosis.

Over the last three years, New York surgeon Dr. Salvatore Ruggiero has observed an increasingly large number of patients develop osteonecrosis of the jaw, which can cause the death of jawbone tissue. Dr. Ruggiero says that until a few years ago, cases of jaw necrosis were extremely rare, occurring only among patients receiving radiation therapy to their jaw.

But Dr. Ruggiero says that the new outbreak of osteonecrosis of the jaw cases was occurring exclusively among patients taking a type of osteoporosis drugs call bisphosphonates. All though many of these were among patients taking the more potent injectable form of the medications, many were also occurring with patients taking oral doses of the bisphosphonate drug Fosamax.

Based on this information, Dr. Ruggiero published a study in the Journal of Oral and Maxillofacial Surgery which identified osteonecrosis of the jaw as a side effect of Fosamax. He believes that Fosamax may disrupt the balance between cells that add calcium to the bones and those which take it away, causing bone tissue to slowly rot away.

Based on Dr. Ruggiero’s study, the FDA has announced that osteonecrosis of the jaw may be a side effect of all bisphosphonate drugs, not just the IV drugs. As a result, the FDA has concluded that all bisphosphonate drugs—including Fosamax—should mention jaw necrosis as one of the potential side effects.