By Kris Clouthier
Last month, my 18-month-old daughter had a cough and a fever. When I called her pediatrician, the nurse told me give to her an over-the-counter cough and cold medicine. When I asked her which drugs, exactly, I should look for on the package, she didn't know.
"Dimetapp's a good one," she said.
"Dimetapp?" I repeated.
"Do you know how many different kinds of Dimetapp there are?" I asked.
She laughed. "Look for the purple box."
I didn't laugh. Instead, I asked her to find out the drug names and give me a call back, which she did.
At the time, the Centers for Disease Control (CDC) had not yet issued its warning that cough and cold medications can be dangerous -– and in rare cases deadly -– for infants and toddlers. The report, published in January, cites three infant deaths and 1,519 emergency room visits related to these medicines from 2004 to 2005. The CDC urges parents to give these medicines to children under age 2 only when following the precise instructions of a health care provider.
The three infants who died all had blood levels of pseudoephedrine, a decongestant, that were nine to 14 times the recommended dosage for ages 2 to 12 years. Here are some highlights from the article, which appeared in Morbidity and Mortality Weekly Report:
• There are no Food and Drug Administration (FDA) approved dosage recommendations for the use of these medications in children under age 2. It's unknown what dosages will cause illness or death in this age group.
• Clinical studies have shown that, in kids under age 2, cough and cold medications are no more effective than a placebo in treating upper respiratory infections.
• The American Academy of Pediatrics sounded the alarm on this issue 10 years ago, urging health care providers to tell parents that these medicines will not suppress a cough and carry a risk of side effects and overdose.
• In 2006, the American College of Chest Physicians issued clinical guidelines "advising health care providers to refrain from recommending cough suppressants and other over-the-counter (OTC) medications to young children because of the associated morbidity and mortality."
According to the CDC report, I was smart to ask for exact drug names. In 2006, the FDA stopped the manufacture of one drug, carbinoxamine, which had been mislabeled for use in kids under age 2 despite safety concerns. Production stopped in September 2006, but some medicines containing carbinoxamine could still be on the shelf.
The experience with our pediatrician's office left my husband and I scratching our heads, wondering why these cough and cold medicines don't have the dosages for kids under age 2 on the package, along with the cartoon baby and the words "Infants and Toddlers." Now we know: There are no FDA-approved dosages. This makes me wonder why they're packaged for infants in toddlers in the first place, and how many parents guess the dose once they get the medicine home, rather than calling the doctor.
Now that I've read the CDC report, I think I owe our pediatrician a call. I'd like reassurance that her office will warn parents of the ineffectiveness of these medicines in small children, and the potential dangers.
Adverse events potentially related to use of cough/cold products in children younger than 2 years should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Kris Clouthier is stay-at-home mom to three and a freelance writer. She lives north of Boston.