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

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

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.