SILVER SPRING, Md. Four physicians, including Michael Shannon, professor of pediatrics at Harvard Medical School, and Daniel Levy, president of the Maryland chapter of the American Academy of Pediatrics, testified before a joint committee of Food and Drug Administration advisors Thursday morning that the preponderance of the evidence did not support the use of cough and cold medicines in children under the age of six. The medicines were wholly ineffective, the doctors claimed, suggesting that even one adverse event associated with the use of these medicines in children was one too many.
Led by Joshua Sharfstein, Baltimore, Md., commissioner of health, the petitioners called on the FDA to publicly state that OTC cough and cold products in children under the age of six were not found to be safe or effective given current clinical evidence, in an effort to combat affirmations from the Consumer Healthcare Products Association that kids cough-cold products are “safe and effective when used as directed.”
The petitioners also called for the FDA to mandate label changes prohibiting the use of cough and cold medicines in children under the age of six.
Not included in the petition was the use of analgesics like acetaminophen and ibuprofen in children as a pain reliever or fever reducer. Petitioners acknowledged that these medicines were safe and effective.
Mary Tinetti, chair of the nonprescription drugs advisory committee, noted that the petitioners are relying on a small group of clinicals to support their position on cough and cold products versus an extended history of pubic use. Tinetti said that one cannot disregard mass consumption of the products and suggested that the safety concerns are relatively small. “One can argue that there may be a wealth of evidence” supporting safety and efficacy of these products in children, she said.
On the other side of the issue, CHPA acknowledged that the use of OTC cough and cold products in children under the age of two may be inappropriate, in part because of the difficulty to dose or administer an appropriate dose to infants. Many of the adverse events associated with use of cough/cold medicines in children can be directly linked to issues of overdosing, CHPA noted, suggesting that the issue may be addressed through public education as opposed to pulling products off shelves.
But cough and cold products are both safe and efficacious in children older than two, CHPA contended, especially given the millions of doses that have been administered to children in the past 30 years. Parents wouldn’t re-purchase a product that didn’t work the first time, refuting that the medicines are not effective, and the associated adverse events when compared to use in the general population is acceptably rare.
“How is the purchase of hundreds of millions of doses by parents explained,” asked George Goldstein, a non-voting industry representative on the FDA advisory committee. “I don’t believe the American parent or caregiver is—in a word—stupid.”
“No, people are not stupid,” countered Levy, but parents need to get back to work, and consequently “need and want quick results.”
CHPA offered a three-pronged plan to address concerns over the use of OTC cough/cold medicines in children—including generating awareness around the correct use of OTC medicines; influencing caregivers’ attitude regarding risks associated with the use of OTC medicines; and embarking on a public awareness campaign to help significantly reduce the misuse and overdosing of OTC cough and cold medicines.
The CHPA is also suggesting a pair of label changes. From “Ask your doctor” in the use of medicines for children under the age of two to “Do not use.” And to include a warning not to use antihistamines as a sedative for children, “based on our findings that sedation was the single biggest reason for overdose,” reported Linda Suydam, CHPA president.
CHPA also announced plans to launch a multi-year national education program on the appropriate use of OTC medicines in children.