FDA Panel Says No to Over-the-Counter Allergy Drug Singulair05/05/14
FRIDAY, May 2, 2014 (HealthDay News) -- A panel of expert
advisors to the U.S. Food and Drug Administration on Friday voted
overwhelmingly against moving the allergy drug Singulair from
prescription to over-the-counter status.
The panel voted 11-to-4 against the sale of the popular
medication without a doctor's approval, the
According to the
AP, many on the FDA panel felt there were still questions
over the safety of making Singulair available without a
prescription, especially because some patients would be using it
for "off-label" treatment of conditions such as asthma.
The FDA does not have to follow the advice of its expert panels,
but it usually does.
Two experts in the care of respiratory illness were happy with
the panel's vote.
"My discomfort about Singulair being sold over the counter mirrors the FDA's concern that it may be used inappropriately for the treatment of asthma," said Dr. Andrew Ting, an assistant professor of pediatrics, pulmonary and critical care at The Mount Sinai Hospital in New York City.
"The selection of Singulair over an inhaled corticosteroid for asthma prevention is a decision that should only be made by trained medical professionals," he said. "The risk of asthmatics using Singulair as a rescue medication or in place of an oral corticosteroid such as prednisone could lead to a significant delay in appropriate treatment for exacerbations."
Ting also noted that "Singulair has possible side effects such
as headache, bed wetting and behavioral changes that should be
addressed with the patient before beginning the medication."
Dr. Harlan Weinberg is director of pulmonary medicine and
pulmonary rehabilitation at Northern Westchester Hospital in Mt.
"A major concern would be for this medication's inappropriate use in children as well as patients self-medicating their asthma," he said. And Weinberg added that "medication interactions are always a concern and your use of Singulair with other prescription medications must be reviewed with your physician.
Finally, he said, "there are no well-controlled studies in
pregnant women or with breast-feeding, for determining fetal or
Find out more about a range of allergy and asthma medications at
American Academy of Allergy Asthma &
Copyright © 2014
. All rights reserved.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.