Decision Delayed for Pediatric Cough and Cold Meds

October 9, 2008
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2 to discuss over-the-counter (OTC) cough and cold medications for pediatric use.

Beltsville, MD (Oct. 9)-The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2, 2008, to discuss over-the-counter (OTC) cough and cold medications for pediatric use. The agency has been reviewing these particular drugs since the American Academy of Pediatricians and other groups began calling for a ban on cough and cold medications for children under age 6, based on studies that show no health benefit to this age group.

Despite reiterated calls during the meeting for an immediate ban on such medications for young children, Dr. John Jenkins, head of FDA’s Office of New Drugs, rejected the idea, according to Associated Press. He said such a ban might lead to an even worse situation in which parents offer their children adult medications. But the agency did not dismiss the concerns regarding these drugs.

FDA officials said that they were still not comfortable with the lack of solid scientific data to support the continued use of OTC cough and cold remedies for children between the ages of 2 and 6, reports AP. When the agency set standards for cough and cold medicines nearly 30 years ago, they were based on adult-only studies. Studies show that these drugs are not effective in young children.

“When a treatment is ineffective, its risks-unless zero-always exceed its benefits,” said Dr. Michael Shannon of Boston’s Children’s Hospital, according to AP.

FDA advised last spring that the medications not be used for children under 2, but has not made a similar recommendation for children between age 2 and 6. The agency now plans to decide by spring 2009 what to do about these drugs for children younger than age 11.

Meanwhile, parents are left wondering what to do as another winter season approaches. Most doctors, says AP, suggest rest and plenty of fluids help to clear up a cold.