By NW Staff
In the May issue of NW, we reported that the Food and Drug Administration (FDA) had issued a public health advisory recommending against administration of over-the-counter cough and cold medications to infants and children ages 2 and younger, and that manufacturers had voluntarily removed such products from the marketplace.
According to the FDA, its recommendation stemmed from the risk of serious and potentially life-threatening side effects reported in young children administered cough and cold medicines. The agency had received reports of deaths associated with decongestants and antihistamines in children, most younger than age 2.
On Oct. 7, manufacturers announced they would voluntarily change their product labels, this time to warn against giving cough and cold medicines to children ages 4 and younger. In announcing the changes on behalf of the pharmaceutical companies, Linda Suydam, president of the Consumer Healthcare Products Association, said the latest measures “reflect industry’s overall commitment
to the continued safe and appropriate use of children’s oral OTC cough and cold medicines.”
According to Dr. Janet Woodcock, the director of the FDA Center for Drug Evaluation and Research, the latest warning “seemed like a logical place where it took into account the need to have dosing instructions in children, but also a clear message for parents of very young children” to not use the products. Added Dr. Joshua Sharfstein, the health commissioner for the city of Baltimore: “It’s a huge step forward. There is no
evidence that these products work in kids, and there is definitely evidence of serious side effects. ... “The 2- and 3-year-olds are definitely the highest risk. More than 50 percent of the problem is with these kids. If they don’t have this stuff around the home, they’re less likely to grab it and ingest it.”
An Oct. 9 safety alert from the FDA states: “The FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products, and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.”
The FDA is investigating whether it should extend the ban on pediatric cough/cold products to children ages 11 and younger. A decision is expected by next spring.
From a nutritional perspective, what does this all mean? Without cough and cold medications to rely on, parents are going to need effective ways to help their children when they’re sick – without putting them at risk for serious side effects. Simply put, they will need natural solutions. As a doctor of chiropractic, you can educate your patients about the dangers of pediatric cough and cold medications while suggesting safer alternatives, including a chiropractic wellness program that encourages sound nutrition from day one.
- “Cough, Cold Drugs Not for Kids Under 4.” WebMD Health News, Oct. 7, 2008.
- FDA Safety Alert: Over-the-Counter Cough and Cold Medicines. Posted Oct. 9, 2008
- “Drug Makers: No Cough and Cold Meds for Kids Under 4.” Associated Press, Oct. 7, 2008.