PEDIATRICS Vol. 88 No. 3 September 1991, pp. A94
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RULES WAIVED TO PERMIT USE OF AIDS DRUG BY CHILDREN

J. F. L. MD

Waiving its usual rules for drug testing for the first time, the Food and Drug Administration yesterday approved AZT as a treatment for AIDS virus infections in children.

While azidothymidine, or AZT, has already been distributed to some 1,000 children, the agency's approval to market the drug is expected to open the door to more widespread use by babies and children infected with the virus.

Estimates by Government experts of the number of additional children who could immediately benefit from the wider availability of the drug ranged from many hundreds to several thousand. Over all, Government officials estimate that 6,000 to 20,000 American children are infected with the AIDS virus, but many do not know they are infected...

In giving approval, the drug agency decided not to require that AZT be tested separately for effectiveness in children, as its regulations stipulate. Instead the agency inferred that it is effective in children because it is effective in adults...

As of March, 2,192 cases of AIDS in children under the age of 13 had been reported, according to the Federal Centers for Disease Control in Atlanta, and more than half of the children have died.


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