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Biotech / Medical : wla(warner lambert)

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To: Ibexx who wrote (704)	4/11/1999 10:54:00 PM
From: Brian Malloy	Read Replies (1) of 942

Hmm. I know a little bit about the drug approval and testing process. Let me clarify a little by saying I hope you are not saying that the level of testing required for Rezulin is normal. The FDA doesn't mandate 11 blood tests in the first year for all new drugs. "After a handful of patients developed serious liver problems and died, the FDA ordered changes to the drug's label three times. The agency advised doctors to monitor liver enzymes regularly and discontinue Rezulin use in patients with signs of serious liver trouble. Patients taking the drug must have 11 liver tests during the first year."

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