WASHINGTON - Drugstores began clearing their shelves of over-the-counter cough and cold medicines designed for infants yesterday after leading manufacturers announced they were withdrawing the products amid rising concerns about the safety of the popular formulations.
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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 nonprescription 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 and mounting evidence 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 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 under age 2.
"These medicines are - and always have been - safe at the recommended doses," said Linda Suydam, 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,
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 usual doses.
"Today's action is an important step in the right direction, but FDA must do more to protect children," said Joshua Sharfstein, Baltimore's health commissioner, who led a petition to the FDA after four children died in Baltimore county after taking the medications.
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. He suggested that the FDA strengthen warning labels on the dozens of products still on the market that advise against their use in children under age 6, and bar packaging that includes terms like toddler that might encourage parents to use the medications in children that young.
Some of the agency's reviewers recommended that step in documents prepared for next week's meeting of outside experts. FDA officials said the agency would await the recommendations of the panel.
"All potential actions are on the table," said Joel Schiffenbauer, FDA's deputy director of the division of nonprescription clinical evaluation.
Although many leading medical groups, including the American Academy of Pediatrics, have long questioned the effectiveness of over-the-counter cough and cold medications and recommended against their use, they remain popular.
No one knows how many children have had adverse reactions to to over-the-counter cough and cold medicines, but the Centers for Disease Control and Prevention reported earlier this year that an investigation it launched found that at least 1,500 children under the age of 2 suffered complications in 2004 and 2005.
An FDA review prepared for next week's meeting describes dozens of cases of convulsions, heart problems, trouble breathing, neurologic complications, and other reactions, including at least 54 deaths involving decongestants and 69 involving antihistamines.