Parents Warned Cough Medicines Imperil Infants

[Guest guest]

August 16, 2007

Parents Warned Cough Medicines Imperil Infants

By GARDINER HARRIS

http://www.nytimes.com/2007/08/16/health/16cough.html

WASHINGTON, Aug. 15 — 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 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been withdrawn in the past 15 years were taken off the market because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. , 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 , 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. 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. 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.

*

The material in this post is distributed without

profit to those who have expressed a prior interest

in receiving the included information for research

and educational purposes.For more information go to:

http://www4.law.cornell.edu/uscode/17/107.html

http://oregon.uoregon.edu/~csundt/documents.htm

If you wish to use copyrighted material from this

email for purposes that go beyond 'fair use', you

must obtain permission from the copyright owner.