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Q & A: Children's Cold Medicines
Concerns Mount About Products' Safety and Efficacy

By Jennifer Huget
Special to The Washington Post
Tuesday, October 30, 2007

What has prompted all the fuss about cold medications for young kids?

The Centers for Disease Control and Prevention reported in January that at least 1,500 children younger than 2 had complications from such products in 2004 and 2005; a Food and Drug Administration review found 123 children had died from decongestants or antihistamines between 1969 and fall 2006. The review of infant products was sought by a group of doctors led by a public health official who linked their use to the deaths of four Baltimore area children.

Did the FDA's expert advisers overreact when they warned against using the products in kids 6 and younger? What about these products is so dangerous to little kids?

It appears that most of the complications occurred when children were given more than the recommended dosage of a single medication or more than one medication containing the same active ingredient. Given the millions of doses of these medications that have been administered in the past 20 or 30 years, says Richard Gorman, chairman of the American Academy of Pediatrics (AAP) section on clinical pharmacology and therapeutics, the number of negative incidents has actually been relatively low.

The bigger question, he says, is whether the medications work well enough to warrant taking that small risk. Because these products have never been tested for efficacy in children, Gorman says, it's hard to weigh their benefits against their risks.

So you're saying, besides the safety issue, there's a question about whether these products do much at all to relieve kids' cold symptoms?

Yes.

Why did the FDA permit the sale of potentially dangerous products for children for decades?

These products all contain combinations of decongestants, antihistamines and antitussives -- substances the FDA has long regarded as "generally safe and effective." But assumptions about their efficacy in children were based on data from adult testing. The medical community now knows that such extrapolation isn't appropriate and that direct testing on children would be needed to show efficacy and determine proper dosage.

What's the next step? Will the FDA ban over-the-counter cold products for kids 6 and younger? Will more cold products be pulled from drugstore shelves?

It's too soon to know. The FDA has not taken any action yet beyond its Aug. 15 warning to parents about giving these products to children younger than 2. (In early October, makers of 14 major OTC cough and cold products made specifically for babies voluntarily removed their products.) For ages 2 to 6, the advisory panel narrowly recommended against the use of cold medications; the agency is reviewing those recommendations. For ages 6 to 12, the panel voted not to suggest restrictions.

Cold products for children 2 and older remain on the shelves. The Consumer Healthcare Products Association, which represents the major makers of these drugs, has committed to work with the FDA to design new ways to test the medications on children, according to Elizabeth Funderburk, CHPA's director of communications. CHPA also is planning an education campaign for parents on the proper use and storage of children's cold medications.

What about adults? Can they take these products safely?

While OTC cold and cough products appear to be safe for adults, it's not clear how effectively they really treat cold symptoms, Gorman says. For now, the FDA suggests consumers carefully follow instructions on the products' packages. Never use adult products for children, Gorman says.

So what do I do if my kid gets sick?

The AAP recommends relieving fever with acetaminophen or ibuprofen (not aspirin), administering plenty of fluids, using a cool-mist humidifier to help clear nasal passages and clearing mucus from stuffy noses with saline solution (for babies, a suction bulb). Hot beverages such as soup, tea with honey and hot chocolate can help clear nasal passages and soothe sore throats, Gorman adds.

Some ingredients in cold and cough medications may be helpful in treating conditions other than the common cold, he says.

Which products have been recalled?

Here's a list from the CHPA:

Dimetapp Decongestant Plus Cough Infant Drops

Dimetapp Decongestant Infant Drops

Little Colds Decongestant Plus Cough

Little Colds Multi-Symptom Cold Formula

PediaCare Infant Drops Decongestant (containing pseudoephedrine)

PediaCare Infant Drops Decongestant & Cough (containing pseudoephedrine)

PediaCare Infant Dropper Decongestant (containing phenylephrine)

PediaCare Infant Dropper Long-Acting Cough

PediaCare Infant Dropper Decongestant & Cough (containing phenylephrine)

Robitussin Infant Cough DM Drops

Triaminic Infant & Toddler Thin Strips Decongestant

Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough

Tylenol Concentrated Infants' Drops Plus Cold

Tylenol Concentrated Infants' Drops Plus Cold & Cough

I just bought one of these products. Can I get a refund?

Many retailers are offering store credit or refunds for returned medicines. Terms vary. CVS stores, for example, will give customers cash back with a receipt and store credit without. RiteAid, Giant and Target don't require receipts for refunds.

Some drugmakers are offering coupons for other products. But because the Food and Drug Administration is reviewing cough and cold remedies for kids older than 2, use the coupons to buy adult products only, recommends Richard L. Gorman, chairman of the American Academy of Pediatrics section on clinical pharmacology and therapeutics. And never use those products for children.

Drugmakers that withdrew their products all have different ways to make you whole:

* Little Colds: Call 800-754-8853 for a coupon for a non-medicated cold product.

* PediaCare and Tylenol products: Call 877-895-3665 or download a coupon for $5 at http://www.tylenol.com; click on "Learn more."

* Dimetapp and Robitussin: Call 800-762-4675 for a $7.99 coupon for a replacement product.

* Triaminic: Return the product, used or unused, to the store where you bought it; no receipt is needed for a refund. See other products at http://www.triaminic.com.

If you decide to chuck a cold product, take care to avoid its landing in streams or rivers, urges the American Pharmacists Association. Don't flush it down the toilet. Before you toss it, dilute it with water and mix it with sawdust, cat litter or coffee grounds.

Keep it far from a child or pet, says Mitchel Rothholz, the association's chief of staff.

What about refunds on products for older kids?

"Companies aren't thinking about that right now," says Elizabeth Funderburk, a spokeswoman for the Consumer Healthcare Products Association, the trade association for makers of nonprescription drugs. "They're hoping those products stay on the market."

Francesca Lunzer Kritz contributed to this report with the refunds answer. Jennifer Huget is a frequent contributor to Health. Comments:health@washpost.com.

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