OTC cough and cold products harmful to infants: US FDA

Despite heavy concerns over the potentially dangerous and ineffective over-the-counter (OTC) cough and cold products, parents still resort to these brands for their babies. With a cold and flu season afoot, the US Food and Drug Administration issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age.

OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of cold, the FDA said.

There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.

Big Pharmas, like Wyeth and Johnson & Johnson had taken their OTC cough and cold products off store shelves last year.

Wyeth expressed its support to FDA's decision in a separate release.

"This decision is consistent with our voluntary removal in October 2007 of over-the-counter infant cough and cold products from the global market to help reduce dosing errors and overdoses in children who are most vulnerable to misuse of these medicines," says Cavan Redmond, President, Wyeth Consumer Healthcare.

Wyeth had recalled and replaced its Robitussin products and Children's Dimetapp Cold and Chest Congestion in late November.

The announcement does not include the FDA's final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing. The FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. The agency plans to issue its recommendations on use of the products in children ages 2 to 11 years to the public as soon as the review is complete.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director, Office of Nonprescription Products, FDA. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

The statement is based on the FDA's review of data and discussion at a joint meeting of the Nonprescription Drugs and Paediatric Advisory Committees on Oct. 18 and 19, 2007.

Pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:

"These drugs will not cure or shorten the duration of the common cold. Follow the dosing directions on the label of any OTC medication before buying it and also check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients," he said. "Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs. The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold."