A U.S. advisory panel will recommend if over-the-counter cough and cold medicines should still be sold for children up to age 12 amid complaints the drugs can be dangerous and do not work.
A U.S. advisory panel will recommend if over-the-counter cough and cold medicines should still be sold for children up to age 12 amid complaints the drugs can be dangerous and do not work. The committee's views will be considered by the Food and Drug Administration, which is being pressured by pediatricians to limit marketing of the products.
According to manufacturers said the medicines used by millions of parents were safe and effective for kids when given as directed. Pediatricians, however, said there was no evidence the medicines offered any benefit to kids.
Experts are alarmed by reports of deaths, seizures, hallucinations and other problems in some children who took the medicines. Although the medicines have been widely sold for years, the FDA generally has not required companies to prove they work in children. Instead, data was extrapolated from adults. Problems were very rare and typically followed an accidental overdose, the makers said. A parent may have mistakenly measured too high a dose, or given more than one product that contained the same ingredient. "Some parents and caregivers need better information on how to use these medicines appropriately," said Linda Suydam, president of the Consumer Healthcare Products Association, which represents over-the-counter drugmakers.
Companies have widely advertised the products under names including PediaCare and Little Colds. About 95 million packages are sold in the United States each year, the healthcare products industry group said.