FDA panel says no to over-the-counter allergy drug singulair

May 5, 2014
FDA panel says no to over-the-counter allergy drug singulair
Experts expressed relief at the decision, citing safety concerns.

(HealthDay)—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 Associated Press reported.

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 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. Kisco, N.Y.

"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 infant risk."

Explore further: First generic versions of singulair approved

More information: Find out more about a range of allergy and asthma medications at the American Academy of Allergy Asthma & Immunology.

Related Stories

First generic versions of singulair approved

August 4, 2012
(HealthDay) -- The first generic versions of Singulair (montelukast sodium) have been approved by the U.S. Food and Drug Administration.

Asthma sufferers may be prone to bone loss

May 1, 2014
Some of the 26 million Americans with asthma may also be prone to bone loss. According to a study published today in the May issue of Annals of Allergy, Asthma & Immunology, the scientific journal of the American College ...

Anoro ellipta approved for COPD

December 18, 2013
(HealthDay)—A new inhaled drug to treat a serious lung condition called chronic obstructive pulmonary disease (COPD) has been approved by the U.S. Food and Drug Administration.

Stopping controversial asthma drugs could have downside: study

August 27, 2012
(HealthDay)—It's OK for some patients with asthma to stick with a combination of medications instead of abandoning one because of concerns about complications, a new analysis of existing research suggests.

Need relief from asthma? Communicating with your allergist is key

January 13, 2014
Can't find relief from your asthma symptoms? The way you communicate with your allergist can be the root of your problems. According to two papers published in the January issue of Annals of Allergy, Asthma and Immunology, ...

FDA panel again rejects wider use of J&J's Xarelto

January 16, 2014
A panel of Food and Drug Administration experts again opposed expanding use of Johnson & Johnson's blood thinner Xarelto to reduce dangerous blood clots in a new group of patients, those with acute coronary artery disease.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.