Cold Meds for Infants Are Pulled Drug Makers Voluntarily Issue Recall of 14 Brands

Oct 12, 11:59 PM

Current Headlines: By SUSAN ABRAM

SHERMAN OAKS -- Pharmacist Michael Hall pulled a dozen boxes of infant cold medicines off the shelves of his store Thursday, a scene repeated thousands of times across the country after drug makers voluntarily recalled 14 brands because parents could misuse them.

The move came after the Food and Drug Administration warned of potential health risks to infants, a decision that didn't surprise Hall.

It's not that the medicines are bad, he said, just that the directions for how much to use can be dangerously inaccurate depending on a baby's size.

"We've all been hearing about this for the last two months," said Hall, the head pharmacist at Capitol Drugs on Van Nuys Boulevard. "The problem lies in the fact that it's so easy to cause an overdose. An infant is not a little adult."

Among the items pulled from the shelves of CVS and other drugstores were Johnson & Johnson PediaCare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings' Little Colds Decongestant Plus Cough.

The FDA met earlier this month to discuss a report released in August about the adverse effects associated with giving too much of the medications to children under 2 years old.

Research conducted by the FDA found 54 child fatalities from over- the-counter decongestant medicines over four decades, according to published reports.

The agency found 69 cases of children's deaths connected with antihistamines used to treat runny noses.

Adverse effects

An estimated 1,500 children age 2 and younger were treated in emergency rooms in 2004 and 2005 for adverse effects from cough and cold medications -- mostly overdoses -- according to the federal Centers for Disease Control and Prevention.

"An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often or if more than one cough and cold medicine containing the same active ingredient are being used," according to a statement from the FDA.

Drug companies such as McNeil Consumer Healthcare, makers of Johnson & Johnson drugs, issued a statement supporting the company's decision to pull the medicines.

The company also agreed to the FDA's recommendations to include label changes to over-the-counter cough and cold medicines advising "do not use" in children under 2.

"This voluntary action by McNeil Consumer Healthcare is based on the company's long-standing commitment to the appropriate use of medications by parents and physicians," company President Ashley McEvoy said in a prepared statement.

Dr. Christopher Tolcher, a pediatrician at Encino-Tarzana Hospital and member of the American Academy of Pediatrics, said many pediatricians have been wary of using cold medicines on infants.

Best remedy

That's because the recommended dosage doesn't always take the wide range of children's weights and ages into consideration.

"Most of us haven't been fans of them anyway," Tolcher said. "Parents who have given their children these medicines should not feel that they have harmed their child. These products are being pulled because of misuses, not because they are dangerous."

But while they might be safe if used properly, they don't work very well, he added, saying, "There is no proven effectiveness."

The best remedy is to keep infants hydrated, wipe their runny noses and use a humidifier, he said.

Lisa Smith, who owns and operates Lisa's Infant Toddler Experience in Tarzana, agreed with Tolcher.

The children she cares for are 3 and younger.

"I've been in the business for 35 years, and I've owned my own day-care center for more than 20 years, and (the medicine) doesn't make them feel better," she said. "It either wires them, or just knocks them out."

susan.abram(at)dailynews.com

(818) 713-3664

Precautions for parents

The Food and Drug Administration offers these suggestions for parents on using cough and cold products for children:

Do not use for children under 2 unless given specific directions by a health care provider.

Do not give children medicine that is packaged and made for adults. Use only products marked for babies, infants or children (sometimes called "pediatric" use).

If you are uncertain about the right product for your child, ask a health care provider.

Follow the directions in the "Drug Facts" box. Do not give a child medicine more often or in greater amounts than is stated on the package.

If you don't understand the instructions, don't use the medicine.

If a child's condition worsens or does not improve, stop using the product and take the child to a health care provider.

(c) 2007 Daily News; Los Angeles, Calif.. Provided by ProQuest Information and Learning. All rights Reserved.