Infant cold meds pulled

The message to parents is clear: Don't give cold medicine to children under 2.

Drug makers on Thursday voluntarily pulled kids' cold medicines off the market less than two weeks after the government warned of potential health risks to infants.

Some of the products contain the same ingredients involved in accidental overdoses of two unrelated Kane County infants in 2005.

A 6-month-old Aurora girl and an Elgin boy just under 2 months old both died after they were given lethal doses of prescription cold medicine containing pseudoephedrine and dextromethorphan, according to the Kane County coroner's office.

Those ingredients are also found in over-the-counter cold medications, including some involved in Thursday's recall.

Dosing is difficult for infants and young children. The medicines come in tiny, droplet-size doses, but parents occasionally do not consult or follow directions from physicians, which can lead to accidental overdose.

These products were never that helpful anyway, pediatricians say, which makes any risk unacceptable.

"The vast majority of them just don't work," said Dr. Eddie Pont, a pediatrician with DuPage Medical Specialists in Elmhurst and president of the Illinois chapter of the American Academy of Pediatrics, based in Elk Grove Village.

"These little, innocent colds don't need a lot of intervention," he said.

CVS, Walgreens and other pharmacies said Thursday they would remove the products from store shelves.

Late last month the U.S. Food and Drug Administration tentatively recommended adding the words "do not use in children under 2 years" to product labeling. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers.

The FDA will formally consider revising labeling at a meeting scheduled for Oct. 18-19.

After reviewing reports of side effects over the last four decades, the FDA found 54 child fatalities from over-the-counter decongestant medicines. The agency found 69 reports of children's deaths connected with antihistamines, which are used to treat runny noses.

The Consumer Healthcare Products Association, which represents drug makers, said it will educate parents and physicians on safe use of cold medicines. The trade group stressed that the "medicines are, and have always been, safe at recommended doses."

But industry critics challenged this statement.

"When it comes to children under age 2 there are no recommended doses on these products, so it's not reasonable to claim they are safe and effective when used as directed," said Dr. Joshua Sharfstein, Baltimore's health commissioner.

The FDA is reviewing the safety of cold medicines at the request of Sharfstein and other Baltimore city officials, who reported 900 Maryland children under 4 overdosed on the products in 2004.

Pediatricians say they try to dissuade parents from giving unnecessary medications to young children.

Cold medicines can cause sedation or hyperactivity in some children, said Dr. Helen Minciotti, a Schaumburg pediatrician and Daily Herald columnist. Instead, parents can try saline drops and humidifiers to ease nasal congestion. Elevating one end of a crib mattress can help, she said.

Parents should be cautious about using cold medicines for any child, even those older than 2, said Dr. Timothy Geleske, chief of pediatrics at Northwest Community Hospital in Arlington Heights. Consult your doctor, and strictly follow dosing instructions.

These medicines haven't been proven to relieve symptoms, shorten illness or prevent complications, Geleske said.

"They really don't have a positive effect, and they can on rare occasions have some negative effects.

"I never tell parents they can't use them, but I have never recommended them," Geleske said. "It is nice to have the FDA backing me up."

Pulled off the market:

Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & Toddler Thin Strips, Prestige Brands Holdings' Little Colds Decongestant Plus Cough

If you have these products:

Pediatricians recommend throwing them out. Or call the store where you bought it to ask about a refund.

Safe remedies for an infant's cold

• Use a bulb syringe to clear an infant's stuffy nose. Saline drops can help loosen nasal secretions.

• Keep your infant's head elevated to help his nose drain. During the day, try a swing or a car seat. At night, prop up one end of the mattress.

• Use a vaporizer or humidifier.

• Encourage fluids. An older child with a cough can carry a water bottle to sip, which will help soothe a sore throat.

• Pediatricians recommend flu shots for kids ages 6 months to 5 years.