Consumer Alert Fosamax Femur Fracture Update

August 17, 2012

In addition to litigation alleging osteonecrosis of the jaw ("ONJ") and musculoskeletal pain arising from FOSAMAX® use ^¹, recent studies, reports, and news stories have indicated that long term use of the drug may be linked to atypical femur fractures.^² These fractures can occur during low impact activities and may be preceded by thigh pain for weeks or months prior to the fracture.^³ FOSAMAX® is manufactured by Merck, and is prescribed for the treatment and prevention of osteoporosis, and the treatment of Paget’s disease

In March 2010, the FDA issued a Drug Safety Communication about bisphosphonates, a class of drugs that includes FOSAMAX®, in which it recommended that health care providers “[b]e aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.^{^⁴}” Seven months later, the FDA issued a safety update, announcing that the “risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis” would “be added to the Warnings and Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis.^⁵”

Litigation claiming FOSAMAX® caused atypical femur fractures has started across the nation, and on May 23, 2011, these cases were consolidated into a Multi-District Litigation (MDL). This means that all cases in federal court alleging that FOSAMAX®, or FOSAMAX® and an additional bisphosphonate, caused an atypical femur fracture are now consolidated and centralized in the U.S. District Court for the District of New Jersey^⁶. Currently there are over 500 cases pending in the MDL.

Robins, Kaplan, Miller & Ciresi L.L.P. is actively involved in litigating these cases. Please feel free to contact our offices at 1-800-553-9910.

[1] Click here for more information on ONJ Fosamax claims.

[2] May 2011: NEJM. 2011 May 5;364(18):1728-37. Bisphosphonate Use and Atypical Fractures of the Femoral Shaft. J Schilcher, K Michaelsson, P Aspenberg; November 2010: J Bone Miner Res. 2010 Nov;25(11):2267-94. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force for the American Society for Bone and Mineral Research. E Shane, D Burr, et al, http://abcnews.go.com/GMA/OnCall/fosamax-long-term-bone-strengthening-drug-linked-fractures/story?id=10045179.

[3] Id. See also http://www.fda.gov/Drugs/DrugSafety/ucm229009.htm

[4] http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

[5] Id.

[6] http://www.jpml.uscourts.gov/pending-mdls-0

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