Fosamax Duration of Use Questioned by FDA

Posted by Sarah Showard | Nov 21, 2011 | 0 Comments

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In September, The FDA's Reproductive Health Drugs Advisory Committee and the Drug safety and Risk Management Advisory Committee held a joint meeting to discuss the appropriate duration of use for Fosamax and other bisphosphonates.

Earlier this year the FDA required manufacturers to include language in their labels stating that the optimal duration for patient use has not been determined and that patients should consult with their physicians on a regular basis to re-evaluate their use of these medications.

The Open Public Hearing of the meeting lasted for approximately one hour during which 18 people told their stories. Most asked that a black box warning about the risk for atypical fracture be added to the labels of the drugs and also that the drugs be used only for people with osteoporosis and not osteopenia.

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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