Cold medicine for kids pulled

WASHINGTON -- Give plenty of fluids and saltwater nose drops. These old-fashioned remedies for treating colds in small children are poised to make a comeback now that drug makers have pulled cold medicines for babies off the market.

The move Thursday represented a pre-emptive strike by over-the-counter drug manufacturers a week before government advisers were to debate the medicines' fate. But it doesn't end concern about the safety of these remedies for youngsters.

Thursday's withdrawal includes medicines aimed at children younger than 2, after the Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.

An FDA report found 54 reports of child deaths linked to decongestants and 69 to antihistamines from 1969 to 2006, many of them younger than 2.

A Centers for Disease Control and Prevention report found 1,500 children had been treated in emergency rooms in 2004-05 for "adverse effects" linked to the medications, and three babies died.

Many Modesto parents and child care providers said they had given infants the products and had no reason to fear them.

Concern that parents could misuse the medication seems ridiculous to Chantal Stendardo, 26, of Ceres. Stendardo has given some of the medications to her children and said she was not afraid of giving them too much.

"I can read directions," she said while picking up her 15-month-old son, Brian, from the infant care room at Merryhill Schools in Modesto.

Rich Nolan, 35, of Modesto agreed.

"You just have to follow directions, like anything else," he said while cradling his 5-month-old son, Matthew.

Still, some question whether children younger than 6 should ever be given these nonprescription drugs.

Baltimore officials filed a petition with the FDA, joined by the Maryland chapter of the American Academy of Pediatrics and prominent pediatricians around the country, arguing that oral cough and cold medicines don't work in children so young and pose risks not just for babies but for preschoolers.

"Pediatricians are taught these products don't work and may not be safe. Yet almost every parent uses them," said Dr. Joshua Sharfstein, Baltimore's health commis- sioner and a pediatrician, who blames ads that overpromise relief.

The challenge, he says, will be to persuade parents to try old-fashioned methods, such as suctioning out infants' noses or using salt-water nose drops.

"If you can actually pull a booger out with a suction device, people can feel better," Sharfstein said.

That argument was an easy sell for Noelle Hamlet, 33, of Modesto. The nurse and mother of two said it is safer to require prescriptions.

"Even (health care practitioners) make mistakes. So I think it would be very easy for people who have no training to give their children too much. Doses depend on weight. If you don't have the right scale, you have to take your baby to the doctor anyway," she said.

Familiar product names on list

The Consumer Healthcare Products Association announced Thursday that manufacturers were voluntarily ending sales of over-the-counter oral cough and cold products aimed at infants. The list includes infant drops sold under the leading brand names Dimetapp, Pediacare, Robitussin, Little Colds, Triaminic, and versions of Tylenol that contain cough and cold ingredients.

CVS Caremark Corp. added that it would also end sales of CVS-brand equivalents.

"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda Suydam, president of the industry trade group.

Some parents think drug manufacturers are overreacting.

"Think about how many kids have taken it and it has helped," said Marcus Mumford, 38, of Modesto who has a 3-month-old. "We ask our doctor. But now we are going to need a prescription? That's so much red tape just to give Tylenol."

The American Academy of Pediatrics says in general the drugs shouldn't be used for colds in small children.

"This is not a situation in which pediatric data are lacking, and we are unable to say one way or the other," Dr. Jay Berkelhamer, the academy's national president, wrote the FDA last month. In multiple studies, they have "been found not to be effective in this population at all."

Not having medication readily available frightens Cayce Hasley, 29, of Modesto. Her 15-month-old daughter once had such a high fever that she had a seizure, Hasley said.

"It's really hard with her. It's a little scary," she added.

The FDA is bringing its scientific advisers together next week to debate the issues, but its preliminary review concluded that very young children shouldn't take some of these commonly used medicines. And while the FDA's main focus is on children younger than 6, it also will ask if there's evidence these drugs work in children up to age 12.

Cough, fever fight infection, doctor says

The FDA praised the drug makers' withdrawals Thursday as important for protecting babies.

For other youngsters, parents should understand that cold remedies treat only symptoms, they don't make viruses go away faster, stressed FDA pediatrician Dr. Dianne Murphy, who urged parents 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 to treat."

Most coughs shouldn't be suppressed -- that's how the body clears the lungs, she said. Low-grade fevers are how the body fights infection.

Health groups say that while low doses of cold medicine don't usually endanger an individual child, the bigger risk is unintentional overdose. For example, the same decongestants, cough suppressants and antihistamines are in multiple products, so using more than one to address different symptoms, or having multiple caregivers administer doses, can add up quickly. Also, children's medicines are supposed to be measured with the dropper or measuring cap that comes with each product, not a kitchen teaspoon, which can vary in size.

And, since "the medicine isn't doing what the family wants, instead of giving as directed every six hours, they give every four hours or every two hours," said Dr. Basil Zitelli of the Children's Hospital of Pittsburgh, who sees such children in the emergency room. "What they in effect are doing is poisoning their child."

What to try instead? Pediatric and public health groups recommend:

Providing olenty of fluids and rest

Use suction bulbs to clear infants' noses. Saline nose drops loosen thick secretions so noses drain more easily.

Place a cool-mist humidifier in the child's bedroom.

Give acetaminophen or ibuprofen, as recommended by your doctor, to alleviate pain or discomfort, but check that they don't contain extra ingredients.

Some chest creams can ease stuffiness, but check labels for age restrictions.

Bee staff writer Eve Hightower and the Los Angeles Times contributed to this report.