Parents Warned Cough Medicines Imperil Infants

August 16, 2007
Parents Warned Cough Medicines Imperil Infants
By GARDINER HARRIS
New York Times

Hoping to halt the growing number of injuries to infants and toddlers, the Food and Drug Administration issued an advisory Wednesday warning parents never to give cough and cold medicines to children under the age of 2 unless instructed to do so by a doctor.

The warning is part of a broad reassessment by the agency of the safety of the popular medicines, which have been blamed for hundreds of adverse reactions and a handful of deaths in children under the age of 2.

The F.D.A. will convene a panel of independent experts on Oct. 18 to discuss whether more prohibitions or warnings are warranted. Such meetings often signal that the agency is seriously concerned about the safety of the drugs under review.

The drugs' labels currently advise parents to see a doctor before giving the medicines if their child is under the age of 2, but too many parents are failing to heed this advice, the agency said.

"We continue to see adverse effects associated with the medicines because people are not using them properly," said Susan Cruzan, an F.D.A. spokeswoman.

If, despite label warnings, parents continue to use the drugs inappropriately in young children, the agency could take more serious action, like restricting the drugs' wide availability.Most drugs that have been withdrawn in the past 15 years were taken off the market because doctors and patients failed to heed prominent warnings.

Some prominent pediatricians and public health experts said that the drug agency's advisory did not go far enough.

One group petitioned the agency to ban the marketing of the drugs for children under the age of 6, and some said that the medicines should no longer be sold over-the-counter for use in children at all.

"Unless convincing evidence shows that these medications are effective for children, their easy availability to families should be re-examined," said Dr. Ian M. Paul, a pediatrician at Penn State Children's Hospital in Hershey, Pa.

But the drugs' makers say that the F.D.A. approved the drugs because they are safe and effective. Virginia Cox, a spokeswoman for the Consumer Healthcare Products Association, said that the drugs' labels already advised against their use in children under the age of 2 unless a doctor approved. Ms. Cox said there was no need to raise this age limit to 6.

Some of the drugs have drawings or pictures of infants in diapers on their labels.

The debate results because the standards for drug approvals have changed sharply in the decades since many of the medicines in children's cough and cold products were approved. If those drugs were currently up for review, they would not be approved for use in children because the manufacturers never tested them thoroughly in children.

Instead, the drugs' makers performed studies in adults and then simply assumed that they would work in children. Such assumptions, once common, are no longer acceptable. Indeed, a growing number of studies in children suggest that cough and cold medicines work no better than placebos.

Among the ingredients that have caused concern are anticough medicines including dextromethorphan, which is the DM in many preparations. They can cause neurological problems, including abnormal movements and hallucinations, even in standard doses.

Another is pseudoephedrine, which is a decongestant that has been associated with infant deaths, increased blood pressure and arrhythmias.

Some of the injuries and deaths associated with these products have resulted when parents gave two different products to their child, not realizing that both contained identical medicines, resulting in an overdose.

In rare cases, children have been injured when given recommended doses.

Everyone agrees that more studies in children are needed, but companies have little incentive to undertake new trials because the medicines' patents long ago expired. So the F.D.A. must decide how to regulate drugs that it knows very little about ?- a position in which it frequently finds itself. In such circumstances, it often turns to advisory boards.

Despite the growing worries, sales of the drugs are booming. Most major pharmacies carry a dozen or more brands. The medicines are popular largely because children have an average of 6 to 10 colds each year, far more than adults.

Even those who petitioned the agency to raise the age limit on the drugs said that dramatic regulatory action against the drugs was unlikely.

Dr. Wayne R. Snodgrass, a petition author who is chairman of the American Academy of Pediatrics' committee on drugs, predicted that the advisory committee would recommend stronger wording on the drugs' labels, not an outright ban.

"Personally in a common cold in a young child, I wouldn't recommend these agents," Dr. Snodgrass said.

Dr. Joshua M. Sharfstein, commissioner of the Baltimore City Health Department and an author of the petition, applauded the F.D.A.'s decision to hold an advisory committee meeting and predicted it would lead to changes in the way the agency regulates the drugs.

"Having an advisory committee meeting is a good way for the F.D.A. to switch gears on this," Dr. Sharfstein said.