FDA Sets Pediatric Drug Labeling Rules

The children’s dosage for drugs frequently used in pediatric cases would have to be spelled out on the label under regulations put into place Friday by the Food and Drug Administration.

Every year, more than half of the newly approved drugs that are likely to be used by children have insufficient information from the manufacturers about safe pediatric use, according to the FDA.

The rules, a Clinton administration initiative, are intended to make the manufacturers give doctors and other health care providers more complete information on pediatric use so they won’t be hesitant to prescribe needed drugs, the FDA said.

The FDA cites examples of seizures and cardiac arrest as well as teeth staining and withdrawal symptoms related to inappropriate dosages of drugs for children.

The classic example of the problem has been with AIDS drugs, many of which were approved without pediatric testing, FDA officials say. In some cases, companies retested to determine correct dosages for children after the drugs were approved.

Pharmaceutical industry officials have said they already provide such information for many drugs and questioned the need for a federal mandate.

Industry officials said Friday they had not seen the regulations and would not comment.

The rules also allow the FDA to require pediatric testing of products that are already being sold, for example in cases when a drug is commonly prescribed for children’s use without adequate labeling and could cause significant risk.

One of the regulations allows the agency to defer testing on children until needed testing information is gathered from adults.