Off the shelves

Drug companies are pulling cough and cold medicines for infants, but the motive might be to protect other products

October 12, 2007|By Stephanie Desmon and Chris Emery | Stephanie Desmon and Chris Emery,SUN REPORTER

Makers of 14 infant cough and cold medicines began pulling their products from store shelves yesterday, just a week before Food and Drug Administration hearings on the safety and efficacy of these over-the-counter drugs.

The manufacturers say they removed the widely used remedies for children under age 2 because they fear potential misuse. But critics say the industry merely wanted to head off a possible FDA ban on decongestants and cough suppressants for older children.

Cough and cold medicines for kids over 2 will still be sold.

"These medicines are safe," said Elizabeth Funderburk, a spokeswoman for the Consumer Healthcare Products Association, which represents the drug manufacturers. "These are the rare cases of misuse we are trying to prevent."

FOR THE RECORD - A photograph accompanying an article yesterday on drug companies taking infant cough and cold medicines off the market incorrectly included Concentrated Tylenol Infants' Drops. That product has not been pulled off the market.
The Sun regrets the error.

The action came after a pediatricians group led by Baltimore's health commissioner, Dr. Joshua M. Sharfstein, petitioned the FDA to stop the sale of cough and cold remedies for children younger than 6. The doctors said there are no data showing that the drugs actually work and there is growing evidence that they pose a risk of serious harm.

The deaths of four Baltimore children under the age of 4 in the past six years have been linked to the medications. An FDA review released two weeks ago found that from 1969 through fall 2006, there were 54 reported deaths in the United States involving decongestants and 69 involving antihistamines. Most were in children younger than 2.

Decongestants relieve stuffy noses and sinuses; antihistamines dry up runny noses and help stop coughs. Antihistamines are also used to treat allergic reactions and itching.

In 2005, the U.S. Toxic Exposure Surveillance System, a national database of poisoning cases, recorded up to 88,000 calls about juvenile overdoses or adverse reactions to cough and cold medicines and antihistamines.

"I think it's a good step," Sharfstein said of the industry's action. "Once the question was framed as, `What's the evidence here?' they really didn't have much of an alternative. It was a serious stretch to market products without any evidence for safety or efficacy."

Two FDA advisory committees will hold two days of joint hearings on the issue Thursday and Friday in Silver Spring. Experts say it is difficult to predict what effect, if any, yesterday's actions will have on the outcome of the meetings.

Two weeks ago, the Consumer Healthcare Products Association said members would remove "Consult a Physician" advice on infant cough and cold products, replacing it with a warning against use in children under 2.

Current pediatric dosage guidelines were approved more than 30 years ago. They were based on doses approved for adults because studies were not conducted on children. That was a common practice for decades because of ethical concerns about testing drugs on youngsters.

The few studies conducted on children since then have shown that the drugs do not work at the recommended doses, several pediatricians said.

Dr. Steven J. Czinn, chief of pediatrics at the University of Maryland Medical Center and a signatory to Sharfstein's petition, said some parents wrongly assume that these medications are safe when they have not been scientifically tested in children.

"It's on the shelf. It's promoted. It's advertised, and all the small print says `not to be used without consulting your ... physician,'" he said. "Too many times, parents are lulled into feeling confident."

The infant cold medicines withdrawn yesterday are sold under the brand-name labels of Dimetapp, Little Colds, PediaCare, Robitussin, Triaminic and Tylenol. Some large chains moved quickly to take the items off the shelf. At some smaller pharmacies, the products were still being sold as managers awaited official word of the withdrawal.

Funderburk said her organization is working to get the word out and intends to make the product withdrawal permanent.

Sharfstein, meanwhile, said he would like the FDA to ensure that it is not temporary and that other companies do not start selling the infant medications. He also recommended that parents throw out any infant cough and cold remedies in their medicine cabinets.

Sales figures for oral, over-the-counter pediatric cough and cold products were not available yesterday but CHPA officials said infant preparations represent about 10 percent of the entire cough-and-cold market. Parents buy the medications because they want to ease what they see as the suffering of their sick children, but doctors say nonpharmaceutical techniques such as drinking liquids and using a humidifier can help.

Arthur Levin, director of the nonprofit Center for Medical Consumers and a past member of FDA advisory panels on prescription drug safety, said the industry's move yesterday might have been described as voluntary, but "it's often not so voluntary."

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