THE FIGHT TO SAFEGUARD AMERICAN DRUG SAFETY IN THE TWENTY-FIRST CENTURY

In the autumn of 2004, the United States faced a public health crisis when Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib), a nonsteroidal anti-inflammatory drug (“NSAID”) that had first been approved by the Food and Drug Administration in May 1999. Over 100 million prescriptions for Vioxx had been written for 20 million consumers, and the FDA subsequently estimated that as many as 55,000 of those consumers suffered fatal heart attacks or strokes from their ingestion of Vioxx.

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