BRIEF: FDA Issues Warning on Cold Remedies: Over-the-Counter Medicines Declared Too Risky for Childr

Jan 17, 05:10 PM

Jan. 17--WASHINGTON -- Parents shouldn't give over-the-counter cough and cold medicines to their infants two years and younger, the government announced today after concluding that the popular drugs may cause life-threatening side effects.

The move by the Food and Drug Administration upends a common reflex of parents, who for decades have turned to Dimetapp, Robitussin and Tylenol to treat their ill infants.

As it turns out, use of the medicines has led, in rare instances, to death, convulsions and other serious side effects. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2," said Dr. Charles Ganley, who leads the FDA's Office of Nonprescription Products.

Dr. Joshua M. Sharfstein, the Baltimore City Health commissioner, led a group of pediatricians who asked the FDA to stop the lucrative sales of cough and cold medicines.

The FDA still must decide whether to extend the restrictions to children ages 2 to 11. Experts advising the agency found that the remedies aren't effective in those children either. Regulators say they are still reviewing the data and plan on making a decision soon.

jonathan.rockoff@baltsun.com

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