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Limits on children's cold tonics not seen as a cure

As a safety precaution, the FDA may restrict the use of treatments many parents rely on.

October 22, 2007|Alana Semuels | Times Staff Writer

What's a mother to do?

For decades, parents have been turning to the nation's pharmacies for help when their children come down with coughs, runny noses, sneezes and your standard cold. Kid-size doses of pills, sprays and cough syrups fill Americans' medicine cabinets.

Now, the federal government is questioning whether some of these children's medicines should be pulled from drugstore shelves for safety, and some parents are wondering whether officials are going too far.

On Friday, an advisory panel of the U.S. Food and Drug Administration recommended that the agency limit the availability of cold and cough medicines for children under 6 in a move they say is in children's best interest.

Cristina de la Rosa of Glendale, at Griffith Park on Sunday with her 2-year-old daughter, was skeptical. De la Rosa has given her daughter the medicine Robitussin before and said she would do it again if her little one got sick. "It's my kid," she said. "I know what to do."

Talk of new restrictions followed reports that some parents may have given wrong dosages to their children. From 1969 to 2006, the FDA received 54 reports of child deaths associated with decongestants and 69 linked to antihistamines. Most of the kids were younger than 2.

On Oct. 11, CVS, Rite-Aid and other drugstores pulled 14 brands of over-the-counter cough and cold medicines for children under 2 at the manufacturers' request. The brands included Dimetapp, Robitussin, PediaCare and Tylenol.

Then on Friday, the panel of outside experts told the FDA that the medicines should not be used by children younger than 6. The recommendations applied to medicines containing decongestants, antihistamines and cough suppressants.

The federal agency usually follows its advisory panels' recommendations but is not required to. Any final FDA action to restrict kids' use of these medicines could take a year or longer, although drug manufacturers could take action -- as they did this month -- more quickly.

The news left some parents wondering, as flu season approaches, what they will give their children. "It's scary, because if he gets sick, there's nothing he can have," said La Verne resident Tammy Valvo of her 6-month-old son.

She can still medicate her 3-year-old daughter, she said, but hopes drugs for older kids won't be pulled next. Officials "are overreacting," she said. "Just because a few parents didn't know what they're doing."

The FDA also said that over the last 50 years, only 11 clinical studies had been published studying these medicines' effects on children. This led the panel to question whether the medicines were even doing the job for sick kids.

But many parents insist the medicines work.

"When they're sick and in pain, medicines help them feel better," said Thereza Han, who has given her 3-year-old daughter cold medicine and pain relievers. "I only give it to her when she really needs it."

Han said she'd go to her pediatrician for medicines if they were barred from stores. But neither she nor friend Jennifer Park, also the mother of a 3-year-old, were happy about the idea.

"They're overstepping their bounds," Park said of officials' discussions of restricting access to the treatments.

Following the panel's recommendation "would unduly limit parents' access to medicines that work," Linda A. Suydam, president of the Consumer Healthcare Products Assn., said in a statement. "The data clearly show that these medicines are very safe when used as directed and that harm to this age group, while very rare, is attributable in most cases to accidental ingestion."

Other parents are already trying to avoid over-the-counter medicines.

Jim Ciment and Irene Chow gave their year-old daughter a decongestant when she had a bad cold but since then have been trying herbal remedies.

"I'm against giving medicine to kids," Ciment said. "It's too much for their little bodies."

Sylmar resident John Thornton, whose wife is an herbalist, said his daughter, who takes preventive herbal remedies, gets sick less often than her classmates who take over-the-counter medicine.

For those parents who want to avoid medicine altogether, Shlomo Laniado has a piece of advice. Laniado, who was taking his grandson to a pony ride at Griffith Park, said that when he was raising his kids, over-the-counter medicines weren't used as frequently, so he found his own cure.

"I gave them pickles," he said. "It always seemed to work."

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