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."
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."
"At this point, they're worried about their exposure to liability," he said. "There's a level of concern that can't be ignored anymore." The industry, he said, might have calculated that this action would blunt some of the criticism and deflect the FDA from a ban that would extend to children as old as 6.
Many pediatricians say there's no evidence that the medications work for older children either.
"There is no real evidence that anything we currently use is effective," said Dr. Ian Paul, a member of an American Academy of Pediatrics committee that studies the safety of children's drugs.
Peter Lurie, deputy director of the health research group at Public Citizen, a consumer watchdog group, said he believes the move was designed to head off a wider ban on marketing the drugs to children under 6 - one possible result of the FDA hearings scheduled for next week.
"One can only assume that it is fear of additional action that's causing them to take these steps," he said. "It's only the most obvious infant products they are recalling. They probably see the writing on the wall for the younger children and are trying to save the rest of the pediatric market. They are trying to rescue the market for a series of products that do no good, and sometimes cause harm."
Drug manufacturers said the safety of their products is not the issue.
"These medications are, and always have been, safe at recommended doses," Linda A. Suydam, president of the CHPA, said in a statement. "These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children's symptoms.
"But as with all medicines, it's important that parents read over-the-counter medicine labels carefully, use these medicines only as directed and store them safely out of the reach of children."
stephanie.desmon@baltsun.com chris.emery@baltsun.com
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Here's a list of over-the-counter cough and cold remedies for children under age 2 that the pharmaceutical industry is removing from store shelves:
Dimetapp Decongestant Plus Cough Infant Drops
Dimetapp Decongestant Infant Drops
Little Colds Decongestant Plus Cough
Little Colds Multi-Symptom Cold Formula
PediaCare Infant Drops Decongestant
PediaCare Infant Drops Decongestant & Cough
PediaCare Infant Dropper Decongestant
PediaCare Infant Dropper Long-Acting Cough
PediaCare Infant Dropper Decongestant & Cough
Robitussin Infant Cough DM Drops
Triaminic Infant & Toddler Thin Strips Decongestant
Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
Tylenol Concentrated Infants' Drops Plus Cold
Tylenol Concentrated Infants' Drops Plus Cold & Cough
[Source: Consumer Healthcare Products Association]
Safe cold therapies for babies
With the drug industry removing many medicines for children under age 2 from store shelves, the Baltimore Health Department offers this advice for treating young children with colds:
Avoid dehydration. Make sure your child drinks plenty of liquids. Electrolyte-containing products, such as Pedialyte, are good fluids to use if the child is not eating much solid food.
Gently suction the nose. If your infant has difficulty nursing or breathing through the nose because of congestion, you can clear the nose gently with a rubber suction bulb before feedings. You can buy suction bulbs at your pharmacy.
If your infant has very thick mucus, you can use saline nose drops up to five times a day. Mix a quarter-teaspoon of table salt with 1 cup (8 oz.) of warm water. Use a clean eyedropper to place two drops in each nostril, then gently suction the drops out. Wait a few minutes between nostrils.
Consider giving medication for fever. A fever is a temperature of over 99.5 degrees measured under the arm and over 100.5 degrees measured rectally. If your child has a fever:
Discuss when to give acetaminophen or ibuprofen with your child's doctor or nurse.
Watch for warning signs. Contact your doctor or nurse if your child:
Is breathing harder or faster than normal or wheezing.
Has fewer wet diapers.
Is extremely fussy or unusually sleepy.
Has an earache, rash or persistent fever.
Is less than 3 months old or is not better after 10 days.
Exhibits any other symptom that is causing you significant concern.
Consider a cool mist humidifier if the air in your house is dry. Make sure to clean and dry the humidifier regularly to prevent growth of mold and bacteria.
Reduce the spread of the cold. The best way to avoid having others in your home get sick is to wash your hands regularly with soap and water.
Source: Baltimore City Health Department