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September 13, 2011

Vote on Fosamax: FDA panel recommends increasing warning

On Friday, Sept. 9, 2011, two advisory panels for the Food and Drug Administration (FDA) recommended augmenting the cautionary language used on the product labels for Fosamax, a medication prescribed to help osteoporosis patients develop and maintain bone strength and density. Fosamax is currently taken by more than five million women in the United States.

Concerns arose following increasing patient reports of low-trauma femur fractures, osteomyelitis and osteonecrosis of the jaw (ONJ). Reports came most often from patients who had taken Fosamax for more than five years but, in some cases, as few as three years.

Although the panel advised to increase the warnings on Fosamax labels, it did not specify what the new safety warning should say. Furthermore, none of the panel members recommended firmer restrictions on long-term Fosamax use.

Based on the panel decision, the FDA is anticipated to release a revised Fosamax label in November.

Read the full article on the Fosamax panel decision in The New York Times.

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