Reporting Dr. Maria Simbra
PITTSBURGH (KDKA) – A local doctor caused a stir at an open hearing at the Food and Drug Administration about the switch of prescription allergy drug Nasacort AQ to over-the-counter. This is an inhaled steroid.
“These drugs have clearly been shown to affect the growth of children,” says Allegheny General Hospital allergist Dr. David Skoner.
Kids on this medicine lose half a centimeter a year in growth compared to those on placebo. What’s more, adrenal gland function can suffer.
Dr. Skoner presented a case of a six-year-old girl who lost adrenal gland function from unmonitored use of this drug and almost died. Her mother’s message to the fda advisory panel?
“It’s unbelievable you would approve this drug for over-the-counter use and my child will require growth hormone injections for the rest of her growing years,” Dr. Skoner conveys.
The panel voted 10 to 6 to make the drug non-presciption. There were two abstentions.
“I feel confident that a couple of those six that opposed probably opposed because of that case,” says Dr. Skoner.
Usually, the FDA goes with an advisory panel’s recommendations.
“I feel sad about it, because I know there will be children affected by this, through unmonitored use, and may have their growth process or adrenal function impaired,” says Dr. Skoner. He says the FDA’s position is that prominent labeling will lead people to use the drug correctly, and tell their doctor.
“Why would they ever tell their doctor when they went to get an over-the-counter medication to bypass the doctor in the first place?” he asks. “This represents the beginning of a lot of dumping of prescription drugs to over-the-counter drugs.”
The manufacturer and patient advocacy groups who say this improves access and cuts health care costs are pushing for the drug to go over-the-counter. A decision from the FDA could come later this fall.