Sunday, August 26, 2007

FDA Warns Against Giving Cough Medicine to Toddlers

FDA Warns Against Giving Cough Medicine to Toddlers

The Washington Post
By Rob Stein, Washington Post Staff Writer
Thursday, August 16, 2007; A02

The Food and Drug Administration, concerned about the number of children being accidentally overdosed on over-the-counter cough and cold medicines, yesterday warned parents never to give children younger than age 2 such products without a doctor's approval.

The warning came as the agency announced plans to convene a panel of experts Oct. 18 to review the use of popular cold medicines in children because of mounting concerns about whether the remedies are being used safely.

The FDA began investigating the issue after public health authorities raised questions about the products, citing reports of hundreds of overdoses that resulted in a handful of deaths. Doctors petitioned the FDA in March to review the situation.

"Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age," the agency said in an advisory.

The FDA's decision was welcomed by those concerned about the medications.

"The fact that they are doing this is illustrative that this is a real problem that is on their radar screen," said Baltimore Health Commissioner Joshua M. Sharfstein, who was among those petitioning the agency.

Sharfstein noted that over-the-counter cold and cough medications have never been proven to be effective in children, and parents can easily inadvertently administer the medications in doses that can cause heart problems and other dangerous side effects.

"There's no good evidence of the efficacy of these products, and there are significant safety concerns about their misuse," he said.

Current labels already warn parents not to use the medications on children younger than age 2, indicating that stronger action is needed, such are possibly barring direct marketing of the products for use in young children, Sharfstein said.

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These Drugs Are for Colds, Not Fidgets

These Drugs Are for Colds, Not Fidgets

By Leslie Berger, The New York Times, August 14, 2007

In a society that savors convenience, parents are sometimes tempted (or pressured) to use over-the-counter cold and allergy drugs to get their children to sleep. In a widely reported incident last month, a Georgia woman and her talkative 19-month-old son were removed from a flight to Oklahoma after the toddler kept repeating, “Bye-bye, plane!” during the safety demonstration, the annoyed flight attendant suggested a dose of Benadryl, and the mother took offense.

Whatever the merits of that confrontation, doctors say there is one lesson to take away: drugs like Benadryl should never be given to sedate a child. For one thing, they can have side effects, including constipation and respiratory problems. And for another, in some children they produce the exact opposite of the desired effect.

“Instead of becoming sleepy they can become very animated and less controllable,” said Dr. Charles J. Coté, a pediatric anesthesiologist at Harvard Medical School.

That paradoxical reaction to the antihistamines contained in many common cold medicines and allergy remedies occurs in as many as 5 percent to 10 percent of children, some experts say. It is not medically dangerous, but it can take a couple of hours to wear off. Indeed, the fine print on these drugs’ labels warns of possible “excitability.”

Nevertheless, the use of such medicines to make children drowsy is widespread. “Inappropriate use clearly is a very common practice,” said Dr. Philip Walson, a professor of pediatrics and pharmacology at Cincinnati Children’s Hospital Medical Center.

Dr. Philippe Similon, a pediatrician in Manhattan, says the question of how to travel with young children, and whether it is safe to give them nonprescription sedatives, has become one of the most common in his practice.

He advises against it, instead suggesting behavioral techniques. “Make sure they are well rested before they get on the plane,” he said, “that they’ve eaten well and that they have something to distract them like a small toy or a book.”

Dr. Coté and other experts say that while children under 2 tend to have the hardest time staying put in a confined space, they are also the most vulnerable to overdoses and respiratory problems. If a sleeping child’s airways become blocked — by a nose pressed against a seat, for example — the sedation can blunt the natural reflex to shift position.

“There are no real safe sedatives to give children just sort of over-the-counter,” Dr. Walson said. “Sedation is a big deal.”

Dr. Walson was an expert witness in the 2005 trial of a Montana day care operator who was convicted of negligent homicide in the death of a 1-year-old in her care. The jury found she had given children an over-the-counter allergy medicine to get them to nap. “It turned out she’d been buying quarts of it, literally, and giving it to all the babies,” Dr. Walson said.

Most popular allergy and cold medicines were not developed as sedatives; the recommended doses on their labels are meant for their intended use.

Moreover, the Food and Drug Administration has begun a long-sought review of popular nonprescription cough and cold medicines marketed for children as young as 2, in response to concerns that they have caused several serious health problems. The drugs, which include Toddler’s Dimetapp, Triaminic Infant and Little Colds, were approved for sale years before the F.D.A. began requiring rigorous premarket testing, and they were never adequately tested in children.

Diphenhydramine, the main compound in Benadryl, also predates current drug agency standards and was never tested in children, but it is lower on the review’s list of priorities, said Dr. Wayne Snodgrass, a professor of pediatrics, pharmacology and toxicology at the University of Texas Medical Branch at Galveston and chairman of the committee on drugs for the American Academy of Pediatrics.

McNeil Consumer Healthcare, which makes Benadryl, said in a statement that the drug was intended to relieve the symptoms of allergies and colds, and added, “We do not recommend nor condone the use of any of our products for purposes other than those indicated on the label.”

Dr. Kenneth R. Cohen, a psychiatrist in New York who specializes in psychopharmacology, suggested another way of looking at the problem: not the restless children, but the adults who have a hard time dealing with them.

For those adults, he said, there are anti-anxiety medications, which should be taken under a doctor’s direction and should be tried out at home first.

“Children absolutely should not be sedated on airplanes for the convenience of other passengers,” Dr. Cohen said.

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