FDA Repeats Warning on Cold Medicines in Infants

By Anna Boyd
10:13, January 17th 2008
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FDA Repeats Warning on Cold Medicines in Infants

The U.S. Food and Drug Administration scheduled a health advisory for today to warn parents not to give children under age 2 over-the-counter cough and cold medicines “because serious and potentially life-threatening side effects can occur.”

This is not the first time when the FDA has issued a warning like this about drugs for babies and toddlers. On October 18, the FDA held a public meeting of a group of outside advisers to examine the safety and effectiveness of over-the-counter cough and cold medicines for babies and young children, which are sold under a range of brands, including Wyeth’s Robitussin, Novartis AG’s Triaminic and Johnson & Johnson’s Tylenol Plus Cold.

Although the FDA had not concluded about how to deal with the drugs at the time, a number of reviews echoed alarm bells that doctors had earlier raised. Agency safety reviewers wrote that an analysis suggested that the use of some of the medication has been associated with serious side effects and some deaths in patients younger than 6 years old. They also noted that the drugs have not proven to work in children.

Also in October, the FDA said it had 54 reports of death in children linked to decongestants containing the ingredients pseudoephedrine, phenylephrine and ephedrine from 1969 to Sept. 13, 2006, and 69 reports of deaths linked to antihistamines with the ingredients diphenhydramine, brompheniramine and chlorpheniramine. The agency said the bulk of the reports were in children younger than 2. In addition, a number of the deaths occurred in children who had gotten overdoses.

Instead of using the reviewed drugs, pediatricians have released a number of rather old-fashioned methods to treat the disease, such as including humidifiers, saline drops and hydrating fluids such as the classic chicken soup. For a child with more serious symptoms, such as a consistent, wheezing cough that persists for more than a few days, parents should consider seeing a physician.

Because of the meeting in October, drug companies quit selling dozens of versions of such medications targeted specifically to babies and toddlers.

Today’s advisory will mark the government’s first ruling on the issue. The rule comes as the FDA fears that parents have not gotten the message and might still have infant-targeted drugs at home or buy drugs meant for older children, said Dr. Charles Ganley of the FDA.

“We still have a concern. It falls out of people’s consciousness. We’re still in the middle of cold season right now,” Ganley said.

The FDA still has not decided if the over the counter drugs are appropriate for older children to continue using. A decision on this is expected by this spring, the deadline necessary to notify manufacturers before they begin production for next fall’s cold season.

Last year the Centers for Disease Control and Prevention reported that more than 1,500 babies and toddlers wound up in emergency rooms over a two-year period because of the drugs.



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