Bextra And Pravachol Recall And Lawsuit
| Bextra is also known as Valdecoxib. The U.S. Food and Drug Administration (FDA) approved it on November 16, 2001. |
The drug was designed to relive the symptoms of rheumatoid and osteoarthritis to reduce pain from menstrual cycles. On April 7 2005, Pfier was asked by the Food and Drug Administration ( FDA ) to voluntarily withdrawn the drug off the U.S. market. Pfizer agreed to the request and withdrawn the product from the market.
FDA announced that it "has concluded that the overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs."
The drug manufacture has legal responsibility to make the drug as safe as possible. If they fail to provide adequate warnings about the nature of the drugs, , they will be responsible for pharmaceutical liability case.
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