Drugmakers Issue Warning
Wednesday, October 8, 2008
The makers of cold and cough medications announced yesterday they are voluntarily warning parents not to give their products to children younger than 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 younger than 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 the result of accidental overdoses. The most common complications include hives, dizziness and difficulty breathing.
Industry representatives, who face the prospect of a 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 younger than 6.
"I am disappointed that the FDA has not followed the recommendations of its own advisory panel," Sen. Christopher J. Dodd (D-Conn.) said in a letter to Commissioner Andrew C. 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."
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said the agency is collecting more scientific information before making a decision.
Joshua M. Sharfstein, the Baltimore public health commissioner who has led a coalition of pediatricians advocating tighter restrictions, said that both the industry and the FDA have a responsibility to educate the public on the new recommendations.
"It's important that this not just be an announcement but that the shelves reflect this policy, as well," he said in an interview.
In the meantime, doctors are reiterating that researchers have yet to find a cure for the common cold.
"There is no treatment," said Michael Shannon, director of the clinical pharmacology program at Children's Hospital Boston. "The best thing a parent can do is comfort measures, such as fluids and rest. Cough and cold medicines do not work."