Beware Doses of Newly Approved Drugs

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August 20, 2002

Beware Doses of Newly Approved Drugs

New drugs in the United States are approved at dosage levels later

discovered to be too high about 20 percent of the time, town

University researchers have found.

In most cases, the dosages were lowered later, but not until many patients

are subjected to side effects and higher prescription costs. Researchers

made the findings based on label changes made for all new drugs approved by

the Food and Drug Administration between 1980 and 1999.

" This pattern may represent a systematic flaw in pre-marketing dosage

evaluation, " researchers said. In a separate study, Dutch researchers found

similar dosage changes for drugs introduced in other countries -- with the

exception of antibiotics, which tended to need dosage increases.

Possible reasons for the situation, researchers said, include subsequent

research finding lower doses can be as effective but safer, changes in

regulatory practices, and misjudgments made in the early phases of new drug

development