Government health officials said Friday they are reviewing whether popular medicines such as Tylenol Plus Cold & Cough and Infant Triaminic...
WASHINGTON — Government health officials said Friday they are reviewing whether popular medicines such as Tylenol Plus Cold & Cough and Infant Triaminic Thin Strips are safe and effective in treating children’s colds and coughs.
Disclosure of the Food and Drug Administration (FDA) review, which will take months, came as critics charged that many over-the-counter (OTC) cough and cold remedies can harm toddlers and preschoolers. Those critics, including public-health officials and pediatricians, are pushing the government for stricter warnings to prevent life-threatening overdoses.
“We have been looking at this issue internally with regard to the safety and efficacy of the use of these products in children,” Dr. Charles Ganley, director of the FDA’s office of nonprescription-drug products, said as he responded to a petition filed Thursday by Baltimore officials and others. The review covers medicines that include decongestants, antihistamines, cough suppressants and expectorants.
The petition is not the first warning about the use of such medicines with toddlers and babies. The American Academy of Pediatrics began issuing those warnings to parents in 1997. Two months ago, the Centers for Disease Control and Prevention (CDC) reported that more than 1,500 toddlers and babies wound up in emergency rooms in a two-year period because of the drugs.
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The study’s authors told parents to consult a doctor before giving the remedies to children younger than 2.
The labels of every cough and cold remedy caution parents to do that, said Linda Suydam, president of the Consumer Healthcare Products Association, which represents makers of over-the-counter medicines. “OTC cough and cold remedies have a long history of safety when used according to the label,” Suydam said.
Still, product packaging often bears images of children apparently much younger than 2, and terms such as “infant” and “baby.” The petitioners called that misleading, adding that the average drugstore stocks more than 30 such products.
The FDA has never approved dosing recommendations for the 0-2 age group for the drugs. The petition asks the FDA to require that labels say the products shouldn’t be used to treat children younger than 6.
In large doses, the drugs can increase blood pressure, cause irregular heart rhythm and lead to strokes and death, Baltimore’s commissioner of health, Dr. Joshua Sharfstein, said.
Material from Bloomberg News
is included in this report.