22% of new prescription drugs undergo recommended dosage changes afterlaunch, and 80% of these changes are dosage reductions, James Cross and Carl Peck of the US Food and Drug Administration have told the annual meeting of the American Society for Clinical Pharmacology and Therapeutics, reports Reuters.
The dosage of a drug approved during 1995-99 was twice as likely to change as one approved in 1980-84, due partly to more educated, alert consumers who talk to their doctors. "Doctors are then talking to the FDA and the drug companies," said Dr Peck. The study opens a window on the drug approval process, he said; while companies and the FDA do their best to get the dose right when a drug is launched, consumers should be aware that the dosage might be too high or too low for any given person, given the need to develop drugs fast to get them out to the people who need them, he said.
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