By GARDINER HARRIS
The New York Times
WASHINGTON (March 2) 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.
Concerns About Cold Remedies
Craig Mitchelldyer, Getty ImagesCold medicines line a pharmacy shelf. The government review began after doctors and health officials demanded that drug makers be stopped from marketing certain remedies for children under age 6.
The official, Dr. Charles 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 “were 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 hearts 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 Toddlers 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, many people use these products even though they have no effect on colds, and theres a real risk of a problem,” said an author of the petition, Dr. Joshua 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 whats a safe and effective dose in children,” Dr. Ganley said. Linda 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 Toddlers 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 childrens 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. Paul, 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 nations 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.” Childrens 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 Citizens 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. John Schwartz contributed reporting from New York.
By GARDINER HARRIS