Vioxx (We are no longer accepting cases on this product)

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VIOXX CAUSES 4-5 FOLD INCREASED RISK OF HEART ATTACK

Vioxx’s manufacturer, Merck’s response has been inadequate. Almost four years ago (November 2000), the VIGOR study found Vioxx caused a four- to five-fold increase in heart attacks. More than three years ago, Merck received (Sept. 17, 2001), a warning letter from the U.S. Food and Drug Administration (FDA) because the company’s ads for the drug failed to mention this increased risk of heart attacks. In the eight-page warning letter addressed to Merck President and CEO Raymond V. Gilmartin, the FDA stated:

“You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).”

In Merck’s VIGOR study, comparing rofecoxib to naproxen, there was a highly statistically significant five-fold increase in heart attacks in the overall rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). This translated to 20 heart attacks with rofecoxib (out of 4,047 patients) compared with 4 with naproxen (out of 4,029 patients). In addition to the increased number of heart attacks, there was also an increase in other thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs as well as problems with hypertension in the rofecoxib group compared with the naproxen group.

Three and a half years ago Public Citizen’s “Worst Pills, Best Pills News” (now online at WorstPills.org), warned readers that both Vioxx and Celebrex were DO NOT USE drugs – their designation for drugs that are not safe and effective enough to use. Although Merck’s withdrawal of Vioxx “solves” the serious safety problems with future use of VIOXX, the most-prescribed alternatives, Celebrex and Bextra, also have some concerns about their cardiac toxicity. Please watch this website or visit WorstPills.org for futher developments on the safety of these drugs.

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