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Fen phen dangers have been known prior to the FDA approval of the diet drug. When fen phen was recalled in 1997, the FDA stated in the withdrawal announcement that the agency was acting on new evidence about significant fen phen dangers. According to key witnesses in fen phen lawsuits, the fen phen dangers were well known about before the FDA ever concluded that the fen phen dangers were too high a risk for fen phen users to take.
The fen phen lawsuits alleged the company American Home Products had the rights to market and manufacture the diet drug and used this to withhold information regarding fen phen dangers. Evidence was shown that American Home Products knew about some fen phen dangers, including primary pulmonary hypertension, but failed to include some fen phen dangers in the adverse section portion of the labeling. It was not until the Mayo Clinic released a study showing the fen phen dangers included heart valve defects did the FDA begin to investigate the safety implications of fen phen.
The makers of fen phen never supplied the FDA with evidence of studies showing either the effectiveness or safety of fen phen and allowed an estimated 6-7 million Americans to be exposed to fen phen dangers.
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More Fenphen Resources
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