Children's Medication Safety Alert

Our children's health and well being is so important. Last week cold drugs for children under two were being pulled off the counter for safety issues. What surprises me most about this is that the actual harmful ingredients have been unnamed "antihistamines and decongestants" with brand names. Many of these are combination of two or more medications.

One of the several brands recalled lists the actual name of the drug causing the deaths. All the brands should have the offending drugs listed. When parents know the actual medication, they can check other medicines they may still have in their medicine cabinet, and on the drugstore counter. Though a "voluntary" recall the New York Post states, "...some small companies may continue selling the product". Safety reviewers in the FDA "considered" the ban on this cold medication two weeks ago.

The reasoning behind this decision surprises me, also. They are safe when taken as directed , but "rare patterns of misuse" can lead to death. Misuse of just about anything will lead to an adverse outcome. Does that warrant removing the items in question? With almost a thousand products that fit this description (some maybe under other names not on the list), it should be known what the actual medication are that are causing the problem. My research on the Internet yielded the following.

For instance, Dimetapp contains Brompheniramine (the antihistamine) and pseudoephedrine (the decongestant). Active ingredients in Robitussin include dextromethorphan (cough suppressant) and guaifenisin (mucolytic). These are made by Wyeth. Clicking on the medicines at their respective websites, reveals the active ingredients. The press release on JNJ's (Johnson & Johnson) website leaves the ingredients out. The Tylenol website lists some of the Pediacare formulas' ingredients, and omits those for Tylenol products. Novartis manufactures Triaminic. The press release section at it's web site fails to mention the recall. Further navigation to Triaminic home page yields front page notification of the recall. Clicking on the product reveals the ingredients. Prestige Brands division, Medtech, makes the Little Colds line. The warning is found under "Investor Relations" in the press section of Prestige's home page. The product home page lists no warning, or product ingredients. Again, clicking on the medication informs you about phenylephrine and dextromethorphan. Pediacare, made by Johnson and Johnson, lists its active ingredients as phenylephrine and pseudoepedrine in 4 of its 5 products on the CHPA, Consumer Healthcare Products Association, website (www.otcsafety.org). This organization represents the country's over the counter drug manufacturers and distributors. CHPA voiced its initial concern in a press release 8/16/07, and the voluntary recall was 10/11/07. That is almost two months ago.

The FDA meets this week with "outside" experts to decide if a ban or "voluntary" recall is necessary. In the meantime, parents are responsible for making sure that the 14 products listed are not used in children under two. They must also check other medication not on the list. It appears that pseudoephedrine, phenylephrine, and brompheniramine are the drugs causing the problems. Pseudoepedrine for adults went from over the counter to a "sign for" medication last year.


The websites of the drug manufacturers shows the medications being recalled; however, the actual ingredients in the medication were likely to be missing. It was rather inconsistent. Other drugs, with the ingredients, and some of the listed drugs advised for this age group were still listed here, and for sale on the web. It was somewhat reassuring to see that the companies gave phone numbers to contact for further information.

Hopefully, the FDA meeting will clarify the issue this week. Maybe you will see a press release that lists the drug ingredients, and more readily visibility on the web pages as well as television screens. TV stations now tend to pass this information off these days by telling you to check their website instead of listing it on TV (like they used to do). Everyone does not have access to the Internet. For our children, give us some type of continuity in reporting this type of information across the news wires. The biggest task is to get accurate, detailed information to every parent's mailbox in a timely manner.

by J.L. Richardson. MD, family medicine doctor, patient advocate, and author of Patient Handbook to Medical Care; Your Personal Health Guide, a Writer's Digest 14th International Self-Published Book Award winner in reference books.

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