FDA examines safety of cough, cold drugs for kids

A doctor examines a patient at a hospital in New York in this Dember 12, 2003 file photo. U.S. health regulators said on Friday they have been reviewing the safety of over-the-counter children's cough and cold medications, especially for those under age 2.

WASHINGTON (Reuters) - Health regulators are taking a new look at the safety of children's over-the-counter cough and cold medications, especially for those under age 2, a Food and Drug Administration official said on Friday.

The review includes products with "any of the ingredients that could be contained in cough, cold products that would affect respiratory symptoms," said Dr. Charles Ganley, head of the FDA's Office of Nonprescription Products.

Ganley said the review began in mid-2006 and encompassed the majority of nonprescription cold and cough products on the market for children, including decongestants, antihistamines, cough suppressants and expectorants.

Manufacturers that market cough and cold products for children include Pfizer Inc., Wyeth, Novartis AG, Johnson & Johnson and Procter & Gamble Co.

Of particular concern is whether the doses suggested for children are safe and effective, Ganley told reporters.

Many of the medicines were not tested on younger patients, he said. Instead, manufacturers simply suggest smaller children's doses based on those recommended for adults.

For example, children ages 6 to 12 are supposed to receive half an adult dose while children ages 2 to 6 are to receive one-quarter, he said.

UNDER 2

The agency is looking in particular at possible side effects in children under 2, he said.

"There are still issues, I think, related to the safety of those products in that age group," Ganley said.

Still, "the important thing to note here is there are millions of doses of (over-the-counter) cough, cold drug products that are used on a weekly basis by children very safely," he added.

Ganley said it would take several months to complete the review and urged parents and doctors not to make drastic changes to the way in which they give the medications to children.

"I think they should just continue following the dosing that is on the products right now" and consult a physician when that is called for, he said.

He had no particular recommendation for children under 2, leaving the decision up to doctors.

Linda Suydam, president of the Consumer Healthcare Products Association, said that over-the-counter cough and cold remedies are safe when used according to the label.

"The labels of all cough and cold medicines for children direct parents and caregivers to contact a physician before giving to a child under two," she said in a statement.

The FDA's comments come in response to a New York Times report on a citizens' petition from doctors and public health officials concerned that such cough and cold medicines were risky for children and did not work.

An excess of the drugs can cause irregular heart beats and other cardiovascular problems, according the report.

(Additional reporting by Lisa Richwine)