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FDA Reviewing Safety of Children’s OTC Cough and Cold Medicines

March 2, 2007 – The FDA has announced it has started reviewing the safety of children’s cough and cold medicines.

Charles J. Ganley, MD, director of the Office of Nonprescription Drug Products at the FDA, said in an interview on Thursday that the agency was "revisiting the risks and benefits of the use of these drugs in children" and that "we’re particularly concerned about the use of these drugs in children less than 2 years of age."

The announcement follows a recent CDC report documenting the deaths of three infants aged less than 12 months. All three deaths were associated with cough and cold medications.

The FDA’s drug review began last year and will take several more months to complete, said Dr. Ganley.

The FDA said it was too early to predict whether the review would lead to new regulations. Its comments came in response to a petition filed on Thursday by a group of prominent pediatricians and public health officials demanding that the agency stop drug makers from marketing cold and cough medicines for children under age 6. The petition says that the medicines do not work and that in rare cases they can cause serious injury.

Dr. Ganley of the FDA said most over-the-counter cold and cough medicines had not been adequately tested in children. The doses recommended on many of the products’ labels were no better than educated guesses, he said.

The FDA issued a warning on January 12, 2007 alerting clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years.

Posted: March 2007