Fosamax (alendronate sodium) is an oral bisphosphonate drug manufactured by Merck & Co. that is used for the treatment of osteoporosis. This drug is an oral bisphosphonate used to inhibit bone loss that is caused by osteoporosis. Fosamax has been on the market since it was approved for sale by the FDA on September 9, 1995.
On October 13, 2010, the FDA issued a “Safety Labeling and REMS Notification” to Merck in response to growing concerns regarding potential complications arising from taking this drug. Specifically, the FDA cited the increased risk of developing “atypical fractures and diaphyseal femoral fractures” from prolonged use of Fosamax. The FDA notified Merck & Co. that it should change the drug label on the Fosamax bottle to inform patients of the potential risk of femur (thigh bone) fracture that could occur after prolonged use of the drug (longer than five years).
On August 25, 2004, the FDA issued a Postmarketing Safety Review regarding the link between bisphosphonate use and osteonecrosis of the jaw. After reviewing a large amount of adverse event reports, the FDA recommended changes be made to all bisphosphonate product labels to “include language about osteonecrosis.” The agency recommended these changes be made especially on the product labels for Fosamax (alendronate), Actonel/Atelvia (risedronate) and pamidronate.
If you or a loved one have taken a bisphosphonate drug such as Fosamax, please contact our firm at 1-800-247-1623 or firstname.lastname@example.org for a free consultation to discuss your legal rights.
Actonel® is a registered trademark of Procter & Gamble Pharmaceuticals, Inc. and is used for informational and product identification purposes only. Atelvia® is a registered trademark of Warner Chilcott Company and is used for informational and product identification purposes only. Fosamax® is a registered trademark of Merck & Co., Inc. and is used for informational and product identification purposes only.