Reuters, "Drugmakers recall infant cough/cold medicine"

Johnson & Johnson, Wyeth and other makers of infants' nonprescription cough and cold products are recalling certain medicines in the United States because of the danger of overdose, the Consumer Healthcare Products Association said on Thursday. Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines, as well, because data show that when the medicines are misused, it can lead to overdose, especially in children under 2 years old.

At least one U.S. pharmacy chain pulled the products from its shelves. CVS Pharmacy, the retail unit of CVS Caremark Corp, said it will immediately remove those recalled medicines and store-brand equivalents. A spokeswoman for the Consumer Healthcare Products Association, a trade group representing makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances, but stressed the medications are safe when used as directed.

U.S. Food and Drug Administration reviewers have said that from 1969 through 2006 the agency received 54 reports of deaths with decongestants and 69 with antihistamines. Most were in children younger than 2. Overdose and drug toxicity were commonly reported in those cases, they said. FDA reviewers have recommended that 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. The FDA has not made a final decision on whether to change the warnings or instructions on the widely used drugs until it gets input from outside advisers who are to meet October 18-19. Questions have been raised about the safety of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.