Cold medicines for infants pulled
OVERDOSE WORRIES FOR POPULAR BRANDS
By Barbara Feder Ostrov
Mercury News
Article Launched: 10/12/2007
01:34:04 AM PDT


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The decision by drugmakers to pull popular infant cold medicines has parents cleaning out their bathroom cabinets and scrambling for old-fashioned remedies as cold and flu season approaches.

Because of fears that the products may be misused and possibly lead to fatal overdoses, leading drugmakers Thursday to voluntarily remove 14 over-the-counter medications from the market. The medicines include top-selling products sold under the brand names Tylenol, Triaminic, Robitussin, Little Colds, Pediacare and Dimetapp.

The decision does not affect cold and cough medicines intended for children 2 years and older, or single-ingredient fever reducers or pain medications for infants.

Parents are advised not to use pulled medicines they may have at home for children younger than 2 years old. Whether refunds will be granted differs by manufacturer and drugstore.

Drugmakers say infant cold medications are safe when taken as directed, but concerns are mounting about overdoses and accidental ingestion of the drugs.

The withdrawal comes a week before a Food and Drug Administration meeting to review the safety and effectiveness of pediatric cold medications. At the meeting, the federal agency may strengthen warnings about the medications' risks for children and require new package labeling, as some health advocates have urged.

At least 1,500 children under age 2 required emergency-room care in 2004 and 2005 after taking non-prescription cough and



cold medicines, health officials reported. Another review conducted for the FDA documented 54 deaths involving decongestants and 69 involving antihistamines from 1969 to 2006.

"These medicines are - and always have been - safe at the recommended doses," said Linda Suydam, president of the Consumer Healthcare Products Association, which announced the withdrawal on behalf of drug manufacturers. "These voluntary actions are being taken out of an abundance of caution."

Many pediatricians already urge parents not to give cough and cold medications to their young children, saying they simply don't work that well.

"This should not be viewed as some tragic day for parents with sick kids, because these medications didn't do much to begin with," Dr. Peter Contini, a San Jose pediatrician, said Thursday.

In August, the federal government advised parents not to give any cold and cough medications to children under 2 unless specifically directed to do so by a doctor.

Yet the drugs remain popular, Contini said, because parents want to ease their children's misery.

Laura Ino is one San Jose parent who plans to keep using cold medications for her son, who turns 2 next week. As a manager of pharmaceutical clinical trials, Ino is confident the medicines are safe when used as directed, but she acknowledged that parents could overdose their children if they are not careful. She said she keeps close tabs on her child's weight to ensure the proper dose and calls the doctor with any questions.

"I totally believe in them," Ino said of the medications. "I don't believe your kids should suffer."

In contrast, Sarah Granger of Menlo Park spent Thursday clearing her 21-month-old daughter's cold medications out of the medicine cabinet. This week, she has been giving her daughter two of the withdrawn medications for a cold.

"Accidents happen, so I think it's smart they're recalling these medications until they can figure out how to dispense them more safely," said Granger, who writes for the Silicon Valley Moms Blog. Her daughter was feeling better Thursday, "but I'll be anxiously awaiting replacement options."

Those options, pediatricians say, include old-school remedies: infant or children's Tylenol or Motrin to reduce body aches and fever, a humidifier, rest and plenty of fluids, Contini said.

Using a nasal saline spray and a suction device for little noses also can relieve congestion, said Dr. Chris Halaburka, another San Jose pediatrician. Getting a flu shot, which is recommended for children from six months to 5 years old, also can reduce the severity of flu and other respiratory infections, she said.

Her challenge, she said, is helping parents understand what to do to make their children more comfortable - and how to cope with the fact that they might be miserable for a few days.

"It's normal for children up to age 4 to have up to 14 colds a year," Halaburka said. "That's how we build our immune system."



IF YOU'RE INTERESTED

For more information, visit the Food and Drug Administration's Web site at www.fda.gov.



Contact Barbara Feder Ostrov at bfeder@mercurynews.com or (408) 920-5064.



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