CVS, Walgreens, Rite-Aid and other drugstores Thursday stopped selling over-the-counter cough and cold medications for children under age 2 after manufacturers asked them to pull the products because of safety concerns.
The products are not tainted or defective, and drug makers said there was nothing wrong with the medications when used as directed. But they issued the request amid mounting pressure from physicians, public health advocates and others concerned about deaths of young children linked to overdosing.
The withdrawn drugs involve "infant" formulations of cold and cough medications sold under the Dimetapp, Little Colds, PediaCare, Robitussin, Triaminic and Tylenol labels.
The withdrawal came a week before a committee of the Food and Drug Administration was set to review the safety and effectiveness of cold and cough medicine in children. A recent FDA report found that the agency had received 54 reports of deaths associated with decongestants and 69 deaths linked to antihistamines from 1969 to 2006 in children, most younger than 2.
Bob Graul, owner of the Rancho Santa Fe Healthmart pharmacy in San Diego County, said he was alerted by a fax from Johnson & Johnson's McNeil Consumer Healthcare about 4 p.m. Thursday and wasted no time in heeding the notice.
"I'm in the process now of going through and seeing what to pull," Graul said.
The renewed scrutiny of the drugs was prompted in part by concerns raised by public health officials and pediatricians in Baltimore nearly a year ago, after the deaths of four children under age 4 linked to overdoses of the medications in that city.
"This is a good step -- not enough, but it's a good step," Joshua Sharfstein, a pediatrician and Baltimore Health Commissioner, said of the voluntary removal from store shelves.
He said the FDA must prevent the manufacturers involved in the voluntary withdrawal from changing their minds and ensure that no other drug makers attempt to market such medications. "The FDA should make a clear statement," Sharfstein said.
The FDA said it had not asked for the withdrawal but applauded it as "an important step in protecting these infants' health."
Joel Schiffenbauer, a research physician in the FDA's nonprescription drug office, said that despite the manufacturers' action the agency would go ahead with its meeting next week to assess "issues related to the efficacy, safety and labeling" of over-the-counter cold and cough medications.
