Drug Companies Say No Cold Meds for Kids Under 4

FDA supports industry's voluntary action to change labeling as agency continues to assess whether products are safe for the youngest set

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HealthDay Reporter

TUESDAY, Oct. 7, 2008 (HealthDay News) -- Saying they were acting "out of an abundance of caution," the makers of over-the-counter cough and cold medicines said Tuesday that the medicines should not be given to children younger than 4 years old.

In addition, the companies announced that they would be using child-resistant packaging and new measuring devices for the products, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, told reporters at a Tuesday afternoon teleconference.

"This is another step in the reassessment of children's over-the-counter cough and cold medications that has been going on," Woodcock said. "We at FDA support these voluntary actions at CHPA [Consumer Healthcare Products Association]. We are continuing to assess the safety and efficacy of these products."

The FDA has also taken steps to revise the OTC monograph -- written in the 1970s -- for these medicines; FDA monographs help determine how a drug will be marketed. The new monograph will take into account new research, some of which has yet to be completed.

The FDA has had discussions with the OTC [over-the-counter] industry about changing labels, Woodcock said, and, recognizing that the rule-making process would take several years at best, supported this voluntary action.

There will be a transition period while the new labels replace existing labels on products on pharmacy shelves. So parents and caregivers should adhere to the actual labels on the products they have and should consult with their doctor or pharmacist if they have any questions, Woodcock said.

Use of the over-the-counter medicines has been controversial, with pediatricians criticizing the marketing of the remedies for children under 6, citing reports of safety problems -- even deaths -- and a lack of evidence that they work.

"The number-one cause [of problems] is accidental ingestion, so the number-one advice is keep the medication out of the reach of children," Woodcock said. "Number two is follow directions carefully and don't give multiple medications, which may have the same ingredient."

In announcing the new industry guidelines, Linda Suydam, president of the CHPA, said they "reflect industry's overall commitment to the continued safe and appropriate use of children's oral OTC cough and cold medicines," the Associated Press reported.

Companies were voluntarily making the change "out of an abundance of caution," she said. The association represents leading manufacturers and distributors of nonprescription, over-the-counter medicines and nutritional supplements.

The new instructions will appear on products distributed for the coming cold season, Suydam said. Companies will also add a warning to their product labels saying parents should not give young children allergy-relieving antihistamines to make them sleepy, the AP said.

Pediatricians welcomed Tuesday's announcement by the industry, the news service said.

"It's a huge step forward," said Dr. Joshua Sharfstein, Baltimore's health commissioner and a leader in the push to stop marketing the medicines for young children. "There is no evidence that these products work in kids, and there is definitely evidence of serious side effects."

Earlier this month, the FDA held a public hearing on the use of OTC cold medicines for children between 2 and 6 years old. But the agency put off a decision on whether they were safe, saying more data was needed.

Dr. John Jenkins, who heads the FDA's Office of New Drugs, said at the time that agency officials were also concerned that an immediate ban, supported by leading pediatricians' groups, might cause parents to give adult medicines to their children.

"We do not want to do something that we think will have a positive impact, only to have an unintended negative," Jenkins said at the hearing, the AP reported. "That could be an even worse situation."

Back in January, the FDA issued an updated health advisory that cough and cold preparations not be used to treat children under the age of 2 because of possible life-threatening complications. These products include decongestants, expectorants, antihistamines and cough suppressants.

Just prior to that advisory, the makers of cough and cold remedies marketed for infants voluntarily recalled the products.

Despite scant evidence that such remedies are actually effective in children, or adults, an estimated 10 percent of American kids take one or more cough and cold medications during a given week.

Yet the preparations can do more harm than good, research suggests.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.

And the U.S. Centers for Disease Control and Prevention reported that some 7,000 American children under the age of 11 are treated each year in hospital emergency rooms because of problems with cough and cold medications.

More information

Visit the FDA for more on its recommendation regarding over-the-counter cough and cold medications for young children.

SOURCES: Oct. 7, 2008, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Sept. 25, 2008, U.S. Food and Drug Administration notice; Associated Press

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