Washington, Oct. 12: US drugstores began clearing their shelves of over-the-counter cough and cold medicine designed for infants after leading manufacturers announced they were withdrawing the products amid rising concerns about the safety of the popular remedies.
The decision to pull 14 products, including well-known brands such as Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants’ Drops Plus Cold and Robitussin Infant Cough DM Drops, came one week before the Food and Drug Administration plans to hold a hearing on non-prescription cough and cold medications for children.
The hearing is part of a broad evaluation of the products the agency launched in light of doubts about their effectiveness. It comes amid mounting evidence that the medications can cause serious complications, including severe hallucinations and agitation, seizures, high blood pressure and heart and breathing problems that can be fatal in rare cases.
The companies maintain that the products are safe and effective when used properly but said they acted because of the risk of complications when misused. Most complications apparently occurred in children younger than 2.
“These medicines are — and always have been — safe at the recommended doses,” said Linda A. Suydam, the president of the Consumer Healthcare Products Association, the industry group that announced the withdrawal. “These voluntary actions are being taken out of an abundance of caution.”
The companies withdrawing the products — McNeil Consumer Healthcare, Novartis Consumer Health and Wyeth — represent at least 95 per cent of the market.
Critics of the products welcomed the move but called for the FDA to take further action, saying the products pose a hazard even when used at the proper doses.
“Today’s action is an important step in the right direction, but FDA must do more to protect children,” said Joshua M. Sharfstein, Baltimore’s health commissioner, who led a petition after four children died after taking the medications. “Clearly, the products don’t work and are unsafe.”
Sharfstein said the FDA should institute a formal ban on the products for children age 2 and younger to make sure no other companies begin offering them.
In addition, Sharfstein said the agency should strengthen warning labels on the dozens of products still on the market that advise against their use in children younger than 6.
Calcutta brands
Doctors said most of these medicines were available in Calcutta, though some of them were sold in different brand names, adds a staff reporter.
“Tylenol is a commonly purchased medicine by parents. The other medicines are also available over the counter, making them even more unsafe,” said Apurba Ghosh, the director of the Institute of Child Health in Calcutta. He said decongestants and cough mixtures should be avoided as much as possible.
