FDA seeking to have children's dosage information put on medicine labels

October 14, 1992|By Los Angeles Times

WASHINGTON -- The Food and Drug Administration was expected to propose new regulations today to encourage drug manufacturers to provide dosing and other information on medicine labels on how best to use the drugs in children, the Los Angeles Times has learned.

Currently, pediatricians are "in the dark" on how to use many medicines in children because labels fail to provide this information, said FDA Commissioner David A. Kessler. As a result, they must rely on experience or whatever is available in general medical literature, which is "an untenable situation," he said.

"There's a real problem out there and it puts pediatricians in a terrible bind," Dr. Kessler said.

Dr. Kessler, a pediatrician and an attorney, was to announce the new policy in a speech today in San Francisco before the annual meeting of the American Academy of Pediatrics.

Drugs for diseases that afflict only children are studied in children, but children are rarely included in studies for drugs that are used to treat diseases suffered by both children and adults.

Nevertheless, such drugs routinely have been used by pediatricians over the years to treat children, even in the absence of dosing.

"In some cases, pediatric labeling may be based on adequate and well-controlled studies in adults, provided that additional information exists to show that the course of the disease -- and the drugs' effects -- are sufficiently similar in children and adults to permit extrapolation from the adult data to children," Dr. Kessler said in his prepared speech, a copy of which was obtained by the Times.

"There are instances where . . . separate controlled clinical trials in children are not necessary," he said.

Jeffrey C. Warren, a spokesman for the Pharmaceutical Manufacturers Association, said the group would not comment until its members had a chance to study the policy. But he said that the PMA is working with the American Academy of Pediatrics "to identify existing medicines that need to be studied and approved for use in children." And they also will be required to conduct some research in children to determine whether the drugs show any adverse effects or toxicities.

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