Published September 29, 2007 03:50 PM

FDA staff urge warnings on kids' cold medicines

WASHINGTON (Reuters) - Over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not recommended for very young children, U.S. Food and Drug Administration reviewers have recommended.

The FDA has not made a final decision on whether to change the warnings or instructions for use on the widely used drugs, officials said in documents released late on Thursday. The agency will seek input from a panel of outside advisers next month.

Officials said in March they were reviewing use of over-the-counter cough and cold medicines in children. A group of doctors and public health officials had filed a petition voicing concerns that the drugs were risky and not effective for children.

FDA reviewers said reports submitted to the agency "suggest that the use of prescription and (over-the-counter) cough and cold medication in younger children, particularly in children less than 2 years of age, could result in fatal overdoses."

The product labels "should include prominent language to describe the risk of overdose in children," the FDA staff said in a summary posted on the agency's Web site.

They also recommended dropping the statement on many over-the-counter cough and cold remedies urging parents to "consult a physician" about use of decongestants in children under 2 years of age and antihistamines in children under 6 years of age.

"We suggest that the revised wording state that dosing is not recommended in these age groups due to the lack of evidence of efficacy and safety concerns," the FDA staff said.

The agency received 54 reports of deaths with decongestants and 69 with antihistamines from 1969 through 2006, reviewers said. Most were in children younger than 2. Overdose and "drug toxicity" were commonly reported in those cases.


More than 800 cough and cold products are sold in the United States with ingredients that include decongestants, expectorants, antihistamines, cough suppressants, analgesics and fever reducers.

Makers include Wyeth, Johnson & Johnson and Procter & Gamble Co. Officials at the three companies could not immediately be reached for comment.

The Consumer Healthcare Products Association, which represents makers of over-the-counter drugs, said its analysis "supports the safety of these important medicines when used in recommended doses. It also, however, illuminates rare cases of overdose."

The group said it supported changing the labels for all over-the-counter cough and cold medicines to read "Do Not Use" in children under age 2.

(Reporting by Lisa Richwine)


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