Executive: FDA knew of drugs, diseases
Published 12:00 am Wednesday, December 15, 1999
FAYETTE – A former drug company executive testified Wednesday that the Food and Drug Administration knew about reported cases of a rare lung disease associated with the company’s diet drugs.
Five Mississippi plaintiffs in a civil trial against No. 5 drug maker American Home Products have said the drug company knew about more cases of the disease pulmonary hypertension than it put on the warning label for Pondimin and Redux, part of the fen-phen diet drug combination.
But Dr. Marc Dietch, retired director of medical affairs for Wyeth-Ayerst, the pharmaceutical division of AHP, testified Wednesday that the company told the FDA as early as 1994 about more than 50 cases of pulmonary hypertension that could have been associated with Pondimin.
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At the time, the warning label on the drug showed only four cases of pulmonary hypertension associated with the drug. Deitch said the FDA&160;never requested a label change for the drug.
&uot;What was in the label was sufficient information,&uot; Deitch said. &uot;Whether it was four cases or 10 cases or 15 cases. &uot;It made no sense to put a number in&uot; because not enough research had been done as to the association of the drug to the disease, he said. The label was eventually changed, Deitch said, because &uot;we changed it on our own.&uot;
Plaintiffs say they suffer from either pulmonary hypertension or leaky heart valves as a result of using the drugs. Defense attorneys say the plaintiffs are not ill, and that they did not take the drugs long enough to have put themselves at greater risk for the diseases.