children's cough medications

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March 2, 2007

U.S. Reviewing Safety of Children's Cough Drugs

By GARDINER HARRIS

http://www.nytimes.com/2007/03/02/health/02cough.html

WASHINGTON, March 1 - Federal drug regulators have started a broad review

of the safety of popular cough and cold remedies meant for children, a top

official said Thursday.

The official, Dr. J. Ganley, director of the office of

nonprescription drug products at the Food and Drug Administration, said in

an interview 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. "

In higher than normal doses, cold medicines can affect the heart's

electrical system, leading to arrhythmias. Some medicines affect the blood

vessels and, in high doses, have been associated with hypertension and

stroke. In rare cases, children have been injured even when given

recommended doses.

In a recent study of hospital emergency room records from 2004 and 2005,

the Centers for Disease Control and Prevention found that at least 1,519

children under age 2 had suffered serious health problems after being

treated with common cough and cold medicines. Three of the children died,

the disease control agency found.

The F.D.A. 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.

Popular medicines like Toddler's Dimetapp, Infant Triaminic and Little

Colds, which are marketed for use in children as young as 2, should not be

given to children younger than 6 under any circumstances, the petition

says.

Like hundreds of older drugs, many of the medicines in these products did

not receive thorough safety reviews by the F.D.A.

" So many people use these products even though they have no effect on

colds, and there's a real risk of a problem, " said an author of the

petition, Dr. Sharfstein, a pediatrician and the health

commissioner of Baltimore.

Dr. Ganley of the F.D.A. 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.

" We have no data on these agents of what's a safe and effective dose in

children, " Dr. Ganley said.

A. Suydam, president of the Consumer Healthcare Products

Association, a trade group of companies that market over-the-counter cold

remedies, said the remedies had been approved by the F.D.A. and had been

used for decades by millions of Americans. Consumers should take only the

recommended doses, Ms. Suydam said.

Doug Petkus, a spokesman for Wyeth, which makes Toddler's Dimetapp,

agreed, adding that " parents of children under the age of 2 are encouraged

to seek the advice of a physician before administering any

over-the-counter medicine. "

Such cautions " are clearly stated in product labeling, " Mr. Petkus said.

The agency has for decades promised to review systematically the safety of

all old drugs, but for a variety of reasons like budgetary constraints,

time and popularity of a particular drug has not done so.

The pediatricians who petitioned the drug agency acknowledged that

children's cough and cold medicines were generally safe when given in

recommended doses. But they added that overdoses were common, for a

variety of reasons. Parents sometimes give their children two different

brands, unaware that they contain the same active ingredients. Overdoses

can also result when frantic parents try to shove eyedroppers or cups of

medicine into the mouths of crying, spitting babies.

The safety problems might be worth risking, the petitioners said, if the

medicines worked to suppress coughs or clear stuffy noses. But according

to a growing number of studies in children, the drugs are no better than

placebos.

" There is widespread consensus that there is no good evidence for the

effectiveness of several of the compounds used in cold medicines, " said

Dr. Ian M. , an assistant professor of pediatrics at Penn State

College of Medicine who has studied the medicines. Last year, the American

College of Chest Physicians recommended that parents avoid using cough and

cold medicines in children, especially young ones.

Despite these growing worries, sales of the drugs are booming. Most major

pharmacies carry a dozen or more brands.

The market for the medicines is fed by parents looking for anything to

have their children sleep peacefully. Children suffer an average of six to

10 colds each year, far more than adults. A 1994 study found that during

one 30-day span, more than a third of the nation's 3-year-olds were

estimated to have been given over-the-counter cough and cold remedies.

The products' labels and advertising strongly suggest that they work, many

with flavors like grape and cherry.

Little Colds has a cartoon of a cheerful, crawling infant wearing only a

diaper. It promises that it " safely and gently relieves. " Children's Vicks

NyQuil has a cartoon that shows a small, sleeping child hugging a sleeping

puppy.

" Parents will do anything for their kids, " Dr. Sharfstein said. " They will

buy expensive syrups if they think their kid will do better. "

Most cough and cold concoctions have nasal decongestants, antihistamines,

cough suppressants or expectorants - common ingredients with names like

dextromethorphan, guaifenesin and phenylephrine. Most of these drugs have

been around for decades and were approved for sale by the F.D.A. when

standards were far lower than they are today. Medicines were often

approved with little or no testing before 1970 to ensure that they were

safe or effective. Since then, the agency has gradually tightened

standards and occasionally revisits old standards.

The agency has put all the compounds on a " monograph, " meaning that

manufacturers can use and combine them in pills and syrups without doing

any of the expensive and lengthy studies that would be needed for a new

drug. Because the drugs are so widely available, there is no incentive for

manufacturers to perform such studies. Information about their lack of

efficacy and worrisome side effects have trickled out.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group and a

longtime critic of the F.D.A., noted that cold medicines had a troubled

history. A decade ago, many such medicines contained phenylpropanolamine,

or PPA, until studies showing that it could cause hemorrhagic stroke led

the F.D.A. to ban it.

Given such problems, Dr. Wolfe said, the agency years ago should have

taken a closer look at all common cold medicines.

Dr. Sharfstein said there was now enough evidence about the dangers of the

drugs for the F.D.A. to act.

" There is this incredible disparity between how the products are regulated

and what the scientific evidence and consensus states, " Dr. Sharfstein

said.

Schwartz contributed reporting from New York.

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