FDA Confirms Infant-Meds Recall


Months after drugmakers pulled infant cold remedies from most pharmacy shelves, the FDA warns consumers of their life-threatening side effects

Three months after a group of pharmaceutical companies voluntarily recalled cough and cold medicine for children under the age of 2, the Food & Drug Administration has issued its own public health advisory stating that parents should not give infants over-the-counter products because of possible life-threatening side effects.

The FDA notice, however, will not surprise parents who have sought out the medicine at some point during the past three months. Most U.S. pharmacies started pulling the infant medicines on Oct. 12, 2007, when the pharmaceutical manufacturers, including Johnson & Johnson (JNJ) and Wyeth (WYE), issued their voluntary recall. Not all pharmacies pulled the meds from their shelves; a few continued to sell them through late November (BusinessWeek.com, 12/26/07).

Educating Parents

Despite the voluntary recall stripping almost all of the tainted medicines from pharmacy shelves, the FDA believes it was necessary to put out an official recommendation. "Even though a number of manufacturers withdrew [the infant cold and cough medicines], there's a likelihood that a number of parents still have these medications in the home, and that they might be tempted to use them despite the information that came out in October," says Dr. Daniel Cobaugh, director of research at the American Society of Health-System Pharmacists Research& Education Foundation in Bethesda, Md.

It is difficult to estimate how many parents are still using recalled infant cough meds or buying cough meds for older children, which they then give to infants. Recent surveys, however, have shown that many parents believe over-the-counter medicines for children and infants pose no threat to their kids' health.

A poll conducted by National Public Radio, the Kaiser Family Foundation, and the Harvard School of Public Health in December found that 58% of parents surveyed believed medicines available in their local pharmacies were at least "somewhat safe" for children between the ages of 2 and 6. Sixty-two percent of parents also said their doctor at some point had recommended that they use an over-the-counter cold or cough medicine for their children.

Many pediatricians, however, strongly discourage parents from using the products, as do most public health officials. Dr. Charles Ganley, the FDA's nonprescription drugs chief, says in the FDA's Jan. 17 statement that infant medicines "have not been shown to be safe or effective in children under 2."

Side Effects Can Be Fatal

Parents who have used the medicines for years without noticing problems may wonder what is unsafe about them or assume that a few parents' incorrect dosages are unfairly affecting the parents who give out the proper dosage. But pediatricians who criticize the use of cold and cough medicine say the ingredients in the medicine make children hyperactive and irritable and can even be fatal. In 2005, the Centers for Disease Control reported that, over a period of a year, more than 1,500 babies and toddlers ended up in emergency rooms after being given cough and cold medicine .

"If you look at ingredients in OTC meds," Cobaugh says—which include antihistamines, decongestants, cough suppressants, and expectorants—"each of these has the potential for some toxicity." He says that in the cases that were reported by the CDC, "there were decongestants involved in those cases, but dextromethorphan [a cough suppressant] was also involved, as well as acetaminophen."

Cobaugh also notes that many of the ingredients in infant cold meds are also in meds for children over the age of 2. The FDA, however, still has to decide whether to adopt the recommendations of its advisory committee regarding cold medicines for children over 2. For now, Cobaugh cautions, parents should be cautious and "make sure that they follow dosing instructions."

The debate over both infants' and children's cold medicines has been especially intense since August, 2007, when the FDA issued a public health advisory notice stating that a group of government advisors would meet in October to discuss the medicines. The group concluded that the meds were not safe for children under 6. In December, 2007, The New England Journal of Medicine published an editorial urging the FDA to ban the medicine.

A Spoonful of Sugar

For children over the age of two, there may be a safer and simpler alternative to the traditional cold meds. In a study in the December issue of Archives of Pediatrics and Adolescent Medicine, researchers gave 105 children with colds honey, honey-flavored cough medicine, or no treatment. All of the children got better, but parents rated honey as most effective in treating their children's colds.

Honey eventually may be one of the few options left to parents if the FDA issues another advisory on cold meds for children over 2. It is unclear when they will decide, however; Ganley would only say in the statement, "the FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold meds in children."

Galland is an editor at BusinessWeek .

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