WASHINGTON – The makers of cold and cough medicines announced Tuesday they are voluntarily warning parents not to give their products to children under the age of 4, a move negotiated in private with federal drug regulators over the past six months.
Medications with the new warning labels will appear in stores and pharmacies immediately, though experts continue to debate at what age the over-the-counter remedies may be safe and effective. The new labels also advise against using antihistamines to sedate youngsters.
Last winter, the companies agreed to discourage the use of the products in children under age 2.
Each year, drug companies sell 95 million packs of pediatric cold medicine, generating about $300 million in revenue.
More than 7,000 children are rushed to hospitals annually because of adverse reactions, primarily due to accidental overdoses.
Industry representatives, who face the prospect of an outright ban on marketing cold remedies for young children by the Food and Drug Administration, said they took action because the majority of problems occur in 2- and 3-year-olds.
“We did this because we think it’s the right thing to do for parents,” said Linda Suydam, president of the Consumer Healthcare Products Association. She could not provide estimates on the financial impact of the decision.
Doctors who petitioned the FDA for broader restrictions applauded the new warnings but said they do not go far enough. The products “should not be available over-the-counter at least up to age 12,” said Wayne Snodgrass, a pediatrician and clinical pharmacologist at the University of Texas Medical Branch at Galveston.
A year ago, an FDA advisory panel voted to remove from the market all pediatric cold products for children under 6.
“I am disappointed that the FDA has not followed the recommendations of its own advisory panel,” Sen. Christopher Dodd, D-Conn., said in a letter to Commissioner Andrew von Eschenbach. “Another cold and flu season is right around the corner, yet commonly available medical products continue to be marketed and sold to the parents of young children even though they have not been shown to be effective and experts have raised serious questions about their safety.”