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The oral bisphosphonate alendronate sodium (Fosamax; Merck & Co Inc, Whitehouse Station, NJ) was first approved for osteoporosis by the Food and Drug Administration (FDA) in September 1995. From its initial marketing date and up to November 2002, the FDA received Serious Adverse Event (SAE) (defined as death, life-threatening, hospitalization [initial or prolonged], disability, congenital anomaly, required intervention to prevent permanent impairment or damage, or important medical event) reports of severe bone, joint, and/or muscle pain, that developed in 112 women, 4 men, 1 adult of unknown sex, and 1 child after starting therapy with the drug. The age range was 7 to 84 years (n = 109; median = 67 years). The child was a 7-year-old boy who mistakenly received alendronate instead of methylphenidate and developed extreme bone pain in his hips, knees, and ankles after 1 dose.

Bones, joints, and muscles throughout the body were affected. In some individuals, pain began at . . . [Full Text of this Article]

AUTHOR INFORMATION
Diane K. Wysowski, PhD; Jennie T. Chang, PharmD

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