SILVER SPRING, Maryland (Reuters) - Over-the-counter cough and cold medicines that have been widely used for decades should not be given to children under 6 years of age, a U.S. advisory panel recommended on Friday.
The panel said manufacturers need to conduct clinical trials to show the medicines actually work for children.
Members said evidence from studies was lacking and it was inappropriate to keep relying on adult data to suggest the medicines benefit kids.
“The studies that are available do not demonstrate efficacy,” said panel member Dr. Robert Daum, a pediatric infectious diseases expert at the University of Chicago Children’s Hospital.
The U.S. Food and Drug Administration will consider the advice as it weighs complaints from pediatricians that the medicines do not work and can be dangerous for young children.
A group of pediatricians and public health officials have petitioned the FDA to restrict sales for children younger than 6 years old. They are alarmed by reports of deaths, seizures, hallucinations and other problems in some children who took the medicines.
Makers said the products are safe and effective, when given as directed, to children aged 2 and older. Last week, major manufacturers voluntarily pulled 14 cough and cold products for children up to age 2.
The FDA advisory committee, after two days of testimony and deliberations, voted 21-1 that use for kids under 2 should not be recommended for over-the-counter cough and cold products that contain antihistamines, decongestants or antitussives.
The panel voted 13-9 against using the products for children aged 2 and 6. However, in a 15-7 vote, the panel declined to recommend against the medicines for ages 6 to 12.
Although the drugs have been sold for decades, the FDA generally has not required companies to prove they work for children. Instead, data was extrapolated from adults.
The products include versions of Wyeth’s Dimetapp and Johnson & Johnson’s Tylenol and PediaCare. About 95 million packages are sold in the United States each year, according to the Consumer Healthcare Products Association (CHPA), which represents nonprescription drugmakers.
The panel felt reports of serious harm were “very rare” and in many cases related to overdose or misuse, said John Jenkins, director of the FDA’s Office of New Drugs.
The panel recommendations may not translate into any immediate changes in how the drugs are marketed. A formal process for amending current rules could take years, but companies may be able to take voluntary actions.
“We need to take back and discuss internally within the agency all the advice we’ve heard,” Jenkins said.
The agency could issue a public statement about its views on safe and effective use of the products, he said.
Current advice for parents is to follow instructions on product labels and make sure they are not giving children multiple products with the same ingredient, he said. The FDA has never approved language recommending the medicines for kids under age 2, he added.
CHPA President Linda Suydam said nonprescription drugmakers would work with the FDA to develop appropriate studies of effectiveness and she believed the products would remain on the market.
“Under the law, they are still considered safe and effective,” Suydam told reporters.
Johnson & Johnson unit McNeil Consumer Healthcare said it would work with the FDA “to obtain the information necessary to provide parents and doctors with appropriate treatment choices for children.”