WASHINGTON – Drugstores began clearing their shelves of over-the- counter cough and cold medicines for infants Thursday after leading manufacturers announced they were withdrawing the products amid rising concerns about the safety of the popular formulations.
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 a 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 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 the products are safe and effective when used properly but said they acted because of the risk of complications when misused. Most complications apparently occur in children younger than 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, Novartis Consumer Health and Wyeth – represent at least 95 percent of the market, the association said.
Stronger warning labels
Critics of the products welcomed the move but called for the FDA to take further action.
“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. “Clearly, the products don’t work and are unsafe.”
Sharfstein said the FDA should institute a formal ban on the products for children 2 and younger to ensure 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 and bar packaging that includes terms such as “toddler,” which might encourage parents to use the medications in children that young.
“There is no evidence that the products are effective for young children, and there is evidence they can be unsafe, even at the usual doses. This is not just about misuse,” he said, noting that the dosages typically used are untested estimates based on studies in adults.
Some of the agency’s reviewers recommended labeling the products against use by children younger than 6 in documents prepared for next week’s meeting of outside experts. FDA officials said the agency would await the recommendations of the panel.
At least 123 deaths
Industry representatives defended plans to continue marketing products designed for children older than 2, saying they offer parents useful medications. The industry group did, however, favor adding new label warnings advising parents against using antihistamines to help their children sleep, which can be dangerous.
No one knows how many children have had adverse reactions to those medicines, but the federal Centers for Disease Control and Prevention reported 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.
Many doctors say they advise their patients against using the products and instead suggest trying Tylenol to alleviate pain, humidifiers and salt- water solutions to alleviate congestion and plenty of fluids to keep the child hydrated.
