(AP) - Drug makers pulled cold medicines targeted forbabies and toddlers off the market Thursday, leaving parents tofind alternatives for hacking coughs and runny little noses just asfall sniffles get in full swing.
The move represented a pre-emptive strike by over-the-counterdrug manufacturers - a week before government advisers were todebate the medicines' fate. But it doesn't end concern about thesafety of these remedies for youngsters.
Thursday's withdrawal includes medicines aimed at children underage 2, after the Food and Drug Administration and other healthgroups reported deaths linked to the remedies in recent years,primarily from unintentional overdoses.
A remaining question is whether children under 6 should evertake these nonprescription drugs.
Baltimore city officials filed a petition with the FDA - joinedby the American Academy of Pediatrics and prominent pediatriciansaround the country - arguing that oral cough and cold medicinesdon't work in children so young, and pose health risks not just forbabies but for preschoolers, too.
"Pediatricians are taught these products don't work and may notbe safe. Yet almost every parent uses them," said Dr. JoshuaSharfstein, Baltimore's health commissioner and a pediatrician, whoblames ads that overpromise relief.
The challenge, he says, will be to convince parents to tryold-fashioned methods, like suctioning out infants' noses or usingsalt-water nose drops.
"If you can actually pull a booger out with a suction device,people can feel better," Sharfstein said.
The Consumer Healthcare Products Association announced Thursdaythat manufacturers were voluntarily ending sales ofover-the-counter oral cough and cold products aimed at infants. Thelist includes infant drops sold under the leading brand namesDimetapp, Pediacare, Robitussin, Triaminic, Little Colds, andversions of Tylenol that contain cough and cold ingredients.
CVS Caremark Corp. added that it would also end sales ofCVS-brand equivalents.
"It's important to point out that these medicines are safe andeffective when used as directed, and most parents are using themappropriately," said Linda Suydam, president of the industry tradegroup.
The American Academy of Pediatrics disagrees. It said in generalthe drugs shouldn't be used for colds in small children.
"This is not a situation in which pediatric data are lackingand we are unable to say one way or the other," Dr. JayBerkelhammer, the academy's president, wrote the FDA last month. Inmultiple studies, they have "been found not to be effective inthis population at all."
The FDA is bringing its scientific advisers together Oct. 18-19to debate the issues, but its own preliminary review concluded thatvery young children shouldn't take some of these commonly usedmedicines. And while the FDA's main focus is on children under 6,it also will ask if there's evidence that these drugs work inchildren up to age 12.
FDA praised the drugmakers' withdrawals Thursday as importantfor protecting babies.
For other youngsters, parents should understand that coldremedies treat only symptoms, they don't make viruses go away anyfaster, stressed FDA pediatrician Dr. Dianne Murphy, who urgedparents to consult their pediatricians.
"What's the risk? That's what this whole meeting is about,"she said. "You need to weigh is that symptom that important totreat."
Most coughs shouldn't be suppressed - that's how the body clearsthe lungs, she added. Low-grade fevers are how the body fightsinfection.
Health groups say that while low doses of cold medicine don'tusually endanger an individual child, the bigger risk isunintentional overdose. For example, the same decongestants, cough suppressants and antihistamines are in multiple products, so usingmore than one to address different symptoms - or having multiplecaregivers administer doses - can quickly add up. Also, children'smedicines are supposed to be measured with the dropper or measuringcap that comes with each product, not an inaccurate kitchenteaspoon.
And, since "the medicine isn't doing what the family wants,instead of giving as directed every six hours they give every fourhours or every two hours," says Dr. Basil Zitelli of theChildren's Hospital of Pittsburgh, who sees such children in theemergency room. "What they in effect are doing is poisoning theirchild."
What to try instead? Pediatric and public health groupsrecommend: -Plenty of fluids and rest. -Suction bulbs to gently clear infants' clogged noses. Salinenose drops loosen thick secretions so noses drain more easily. -A cool-mist humidifier in the child's bedroom. -Acetaminophen or ibuprofen, as recommended by your doctor, toalleviate pain or discomfort - but check that they don't containextra ingredients. -Some chest creams can ease stuffiness with menthol or otherfragrances, but check labels for age restrictions.