FDA Plans to Revise Standards for Children's Cold Medicines-September 2008


OTC cough and cold medicines for children will be the focus of an upcoming FDA special hearing.

The FDA will hold a special public meeting October 2 to get input regarding OTC cough and cold products marketed for pediatric use. The purpose of the meeting is for the agency to gather information on these medicines including scientific, regulatory, and product use issues.

In response to growing concern that the products are ineffective and could be unsafe for this patient population, the FDA said that, for the first time in decades, it will revamp the criteria that have allowed the products to remain on the shelves.

The announcement follows a January 17, 2008, FDA public health advisory instructing parents not to use oral pediatric cough and cold medicines in children under the age of 2 “because serious and potentially life-threatening side effects can occur from such use.” Last October OTC cold medicines came under scrutiny after drug manufacturers voluntarily withdrew these medicines for children under age 2. During the same month, the FDA’s own Nonprescription Drugs and Advisory Committees voted that the drugs are not effective in small children and should not be given to anyone under the age of 6.

In an effort to educate parents, other caregivers, and health care professionals, the Consumer Healthcare Product Association (CHPA) has launched a multiyear educational program to build awareness about how to safely use OTC cough and cold medicines in children and when not to use them.

The National Association of Chain Drug Stores (NACDS) is also taking action. The association has been in close communication with the FDA and with CHPA on this issue. “We are communicating with NACDS members to determine next steps. Currently, NACDS plans to participate in the October 2 hearing, whether by testimony or by submitting a statement,” said Chrissy Kopple, vice president of media relations for NACDS. “We are focused on the safety of patients, as well as minimizing any public confusion related to this matter. It is important that there is awareness that FDA has taken initial steps to review this matter, and speculations about its outcomes are premature.”

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