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Spokane, Washington  Est. May 19, 1883

Parents balk at banning cold drug

Word that federal safety experts might ban over-the-counter medications sold to treat sniffling babies and coughing toddlers drew praise from Inland Northwest pediatricians this week – but protests from parents who have to care for their ailing tykes.

“I have a 3-year-old, and he gets colds all the time,” said Jacqualynn Krause, 26, of Spokane Valley, mother of Noah. “I am wondering what we are supposed to do when our kids are up all night coughing or their noses are stuffed up.”

Krause’s concerns come at the start of cold and flu season and less than a week after safety experts for the Food and Drug Administration recommended the agency consider banning the multisymptom medications aimed at children under 6.

The move, which will be considered later this month, could affect some 800 medicines marketed in the U.S. for infants and very young children. Safety group members advised the agency to consider removing infant cold and cough medications from the market and standardizing the measuring devices used with products for older children to avoid dosing errors.

There’s little evidence that the cold and cough medicines are effective in young children, and concern is growing that they may be dangerous, FDA reviewers wrote.

That wasn’t news to Inland Northwest doctors, who said they’ve been telling parents for years to avoid products like Infants Tylenol Cold Plus Cough and Robitussin DM Infant Drops.

“That stuff doesn’t work anyway, so why would you spend money on it?” said Dr. Deb Harper, a pediatrician with Group Health’s Riverpoint campus in Spokane.

The medicines have not been proven to be effective in controlling symptoms of the six to eight colds the average child gets each year, said Dr. Duane Craddock, a pediatrician in Post Falls. The multisymptom medications might make kids sleepy, but they don’t control stuffy noses, coughs or the other annoyances of mild illness.

“Parents aren’t realizing they’re a Band-Aid for symptoms,” said Craddock. “We often tell parents, let the snot run, let the cough go. Get that stuff out of there.”

Not only are the products ineffective, they also might be dangerous. Between 1969 and 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines, the federal reviewers reported. Because reports are voluntary and sporadic, the actual figures could be higher, they noted.

In January, the Centers for Disease Control and Prevention advised parents not to give the medicines to children younger than 2 after an investigation showed that more than 1,500 babies and toddlers were hospitalized and three infants died in 2004 and 2005 after being dosed with high levels of pseudoephedrine, a nasal decongestant.

In Washington, an Okanogan County child’s death in 2002 was attributed to cold medicine, according to a review of state death certificate records.

Worries about the use of cough and cold medicines in young kids date at least to 1997, when the American Academy of Pediatrics said the efficacy of the drugs was unproven and that adverse reactions were possible.

Deaths are rare, area medical officials acknowledged, but injuries are more common. Potential problems include overdose and cardiac arrest, according to the report. Parents might not pay close attention to amounts and frequency of medicines, or they may combine medications without understanding the overall effect.

“People don’t realize that medications made by two different manufacturers are the same thing,” Harper said.

Still, at least one local medical expert said the medicines can be used safely and effectively.

“I personally have used the product in my own kids,” said Sarah Marrinan, a pediatric pharmacist with Sacred Heart Children’s Hospital. “I’ve used them, and I’ve seen relief.”

Marrinan said she supports stricter regulations for cold medicines because many parents don’t use them correctly.

But several parents said they would resist changes for medicines they’ve used safely and effectively for years.

“My oldest child lived, well almost, on Dimetapp, when she was little,” said Barbara Jewell-Potter, of Spokane Valley. The 43-year-old mother of children ages 20, 17 and 2 – all of whom responded well to cold medicines – said she would resent intrusion into her choice of over-the-counter products.

“I believe it should be up to me, with my pediatrician’s advice, what medications I should or should not give my children, not the government.”

It’s unlikely that even a ban on the infant formulations would stop some parents from giving cough and cold medicines to babies and young children, said Dr. Paul Grubb, a pediatrician with Spokane’s Rockwood Clinic.

“Parents want to treat,” he said. “They want their child to be better.”