Drug stores remove cold medicines for infants

Drugstores began clearing their shelves of over-the-counter cough and cold medicines intended for infants after leading manufacturers said they were withdrawing the products amid rising concerns about how safe the medicines are for infants.

The decision to pull 14 products, 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 nonprescription cough and cold medications for children.

The hearing is part of a broad evaluation of the products the FDA started in light of doubts about their effectiveness and 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 say that the products are safe and effective when used properly but said they acted because of the risk of complications when misused, with most complications apparently occurring in children younger than 2.

The companies withdrawing the products are McNeil Consumer Healthcare, Novartis Consumer Health Inc. and Wyeth Inc., which represent at least 95 percent of the market.

Critics of the products welcomed the move but called for the FDA to take further action, saying that the products pose a hazard even when used at the usual doses.

Industry representatives defended plans to continue marketing products intended for children older than 2, saying that they offer parents useful medications.

The organization did, however, favor adding new labels advising parents against using antihistamines to help their children sleep, which can be dangerous.

Over-the-counter cough and cold medications has long been a mainstay for parents trying to comfort children fighting common colds, coughs and other upper-respiratory infections. Although many leading medical groups, including the American Academy of Pediatrics, have long questioned their effectiveness and recommended against their use, they remain popular, especially for distraught parents who are desperate to help a sick child.

Drug stores remove cold medicines for infants

Several leading manufacturers are recalling cold remedies.