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Harold J. DeMonaco, MS

Arch Intern Med. 2009;169(12):1164-1166.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Postmarketing surveillance and the determination of the real-world safety profile of prescription drugs is arguably flawed. Recent identification of significant adverse effects associated with newly approved prescription drugs support the sometimes-held view that a new system needs to be introduced. The present voluntary system has not provided a sufficient early warning system, and some have called for active systems that probe for potential adverse effects of approved prescription drugs.¹ Patient-oriented Web sites may provide an opportunity to identify potential adverse effects early in a drug's postmarket history.

In 2005, Wysowski and Chang² published a letter regarding a series of case reports submitted to the Food and Drug Administration (FDA) on severe bone, joint, and muscle pain associated with the use of alendronate sodium and risedronate sodium for 1995 to 2002. In all, 116 case reports of serious adverse events were voluntarily submitted. A subsequent FDA Alert . . . [Full Text of this Article]

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RELATED LETTER

Alendronate and Risedronate: Reports of Severe Bone, Joint, and Muscle Pain
Diane K. Wysowski and Jennie T. Chang
Arch Intern Med. 2005;165(3):346-347.
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