FDA vote to improve labels on osteoporosis drugs

12th September 2011 - Fine Cut

Information labels on osteoporosis drugs are set to be improved following a vote by the Food and Drug Administration (FDA).

The authority agreed that information regarding the maximum amount of time the drugs can be taken for should be made clearer in order to prevent users experiencing any nasty side-effects such as bone fractures.

Other reported side-effects linked with overuse of the drug include osteonecrosis of the jaw, jaw bone death and an increased risk of cancer.    

An overwhelming majority of the FDA panel agreed that the labels should indicate a time limit before patients require re-evaluation from medical professionals.

However, a lack of substantial research into the effects of the drug meant that the panel were unable to agree how long this time limit should be.

Pharmatimes.com report that the labels are likely to be altered to reflect this lack of clarity. They may instead raise awareness of possible side-effects from prolonged use rather than give direct instructions for use.  

Speaking to Reuters, panel member Brian Erstad claimed the situation was one of the most ambiguous he had ever dealt with.

He said: "I'm used to dealing with ambiguity in a clinical setting, but this raises it to different heights."

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