Consumer Alert: FDA Warns Osteoporosis Drug FOSAMAX ® Linked to Rare, Atypical Femur Fractures

April 8, 2011

Thousands of Americans have been taking the prescription drug FOSAMAX® for treatment and prevention of osteopenia and osteoporosis. According to the Office of the Surgeon General, in 2004, over 10 million Americans over the age of 50 were diagnosed with osteoporosis of the hip joint alone, and the prevalence of osteoporosis is expected to rise dramatically as the population continues to age.[1]

FOSAMAX® belongs to a class of drugs known as bisphosphonates, and has been prescribed to patients diagnosed with osteoporosis and osteopenia since 1995.[2] FOSAMAX® is manufactured by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc..[3] On October 13, 2010, the FDA issued a warning to physicians caring for patients taking FOSAMAX®.[4] The FDA noted that all bisphosphonates (FOSAMAX®, Actonel, Boniva and Reclast) have been associated with atypical fractures to the femur.[5] A report published in the Journal of the American Medical Association suggests that women who have been on bisphosphonates for more than five years are at nearly three times higher risk of suffering these unusual femur fractures than other women.[6] The FDA recommended "Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue [FOSAMAX® and other bisphosphonates] in patients who have evidence of a femoral shaft fracture."[7]

Patients who suffer from these atypical femur fractures typically require immediate surgery including placement of orthopedic hardware such as plates and screws. Given the severity of the fracture, these patients typically experience a very slow recovery process.

Robins, Kaplan, Miller & Ciresi L.L.P. is currently litigating claims on behalf of patients who suffered injury as a result of the prescription drug FOSAMAX®. If you wish to speak with us about a potential claims or an injury caused by use of FOSAMAX®, please call Kathy Neuman, R.N., B.S.N., at 1.800.553.9910, or contact here.

[1] U.S. Department of Health & Human Services, Office of the Surgeon General, Bone Health and Osteoporosis: A Report of the Surgeon General (October 14, 2004), available at

http://www.surgeongeneral.gov/library/reports/bonehealth/index.html.

[2] U.S. Department of Health & Human Services, Food and Drug Administration, Letter Regarding Safety Labeling Change and REMS Notification, available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM229239.pdf.
[3] http://www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf
[4] U.S. Food and Drug Administration, Possible Increased Risk of Thigh Bone Fracture with Bisphosphonates (October 14, 2010)
[5] Id.
[6] Laura Y. Park-Wyllie, PharmD, MSc, et. al., Bisphosphonate Use and the Risk of Subtrochanteric or Femoral Shaft Fractures in Older Women, JAMA, Vol. 305, No. 6 (Feb. 23, 2011).
[7] Supra, note 4.

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