Medications
Resources
Basic InformationLatest News
COVID Drug Remdesivir Could Cost Up to $3,120 Per Patient, Maker SaysHigh Costs Lead Millions of Americans to Shop Abroad for Rx DrugsFDA Pulls Emergency Approval of Hydroxychloroquine for COVID-19How Ritalin Works in the BrainFDA Pulls Heartburn Drug Zantac From MarketTaking More Antibiotics May Up Odds for HospitalizationAllergy Med Singulair to Get 'Black Box' Warning Over Psych Side Effects: FDAU.S. Drug Prices Have Risen Three Times Faster Than InflationUse Pot? It Can Interact With Your Meds in Harmful WaysToo Many Antibiotics, Opioids Given to Dental Patients in the ERBrand-Name Rx Rise After Docs Get Drug Company Perks: StudyAs Prices Rise for Parkinson's, Alzheimer's Meds, Patients Go WithoutPrice Hikes Have Patients Turning to Craigslist for Insulin, Asthma InhalersAI May Help Guide Patients to Most Effective Antidepressant1 in 4 Gets Unneeded Antibiotics at Children's HospitalsStudy Finds 'No Clear Rationale' for 45% of Antibiotic PrescriptionsAre Antibiotics a Recipe for Obesity in Childhood?Do You Take Warfarin? Time of Day Might Not MatterNew Drugs Getting FDA's Blessing Faster, but Is That a Good Thing?Health Tip: Acetaminophen SafetyTwo More Heartburn Meds Recalled Due to Possible CarcinogenMany Drugstores Misinform on Disposal of Unused MedsHealth Tip: How to Remember to Take Your MedicationsFDA to Allow States to Import Prescription Drugs From Other CountriesOver 40% of Antibiotics Could Be 'Inappropriately' PrescribedFDA Testing Levels of Carcinogen in Diabetes Drug MetforminTaking Several Prescription Drugs May Trigger Serious Side EffectsPenicillin Allergy Less Common Than Thought: StudyMany Older Americans Misuse Antibiotics: PollAntibiotics Not Recommended for Most Toothaches, New Guideline SaysHealth Tip: Taking Anti-Inflammatory DrugsMany Common Meds Could Alter Your MicrobiomeWhen Meds Are Free, Patients Take Them More OftenMaker Halts Distribution of Generic Zantac Due to Possible CarcinogenKids Often Prescribed Drugs 'Off-Label,' Raising ConcernsHeartburn Drug Zantac May Contain Small Amounts of Known Carcinogen, FDA SaysHealth Tip: Take Over-the-Counter Medication WiselyA Prescription for Medicating Your Child SafelyHealth Tip: Taking Dietary SupplementsTrump Administration Announces Plan to Allow Cheaper Drug Imports From CanadaAre Too Many Kids Prescribed Antihistamines?Some Meds and Driving a Dangerous DuoHealth Tip: Giving Medicine Safely to ChildrenHigher Cost of New Cholesterol Drugs Putting Patients at Risk: StudyMany Americans Take Antibiotics Without a PrescriptionHealth Tip: Packing Prescriptions for Travel
Questions and AnswersVideosLinksBook Reviews
Related Topics

Anxiety Disorders
Depression: Depression & Related Conditions
Medical Disorders
Mental Disorders
Mental Health Professions

Allergy Med Singulair to Get 'Black Box' Warning Over Psych Side Effects: FDA

HealthDay News
by -- E.J. Mundell
Updated: Mar 4th 2020

new article illustration

WEDNESDAY, March 4, 2020 (HealthDay News) -- Asthma and allergy drug montelukast -- sold as a generic and under the brand name Singulair -- will get a "boxed warning" over potential ties to neuropsychiatric effects, the U.S. Food and Drug Administration announced on Wednesday.

The drug has long carried a warning that it has been linked with an increased risk of "agitation, depression, sleeping problems, and suicidal thoughts and actions," the FDA said in a statement.

The agency's move Wednesday elevates that advisory to its most prominent, boxed warning. The new warning advises health care providers to "avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis [hay fever]," according to the FDA.

"We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions," said Dr. Sally Seymour, who directs the FDA's division of pulmonary, allergy and rheumatology products.

"The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks," Seymour added in an agency news release.

The first such warning added to montelukast labeling came in 2008 after reports of suicide and other serious psychiatric events were reported in users. The agency has since tracked and compiled data linking mental health issues with use of the drug, and a summary was presented at an FDA advisory committee meeting last year.

Based on the committee's assessment, "the FDA determined the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies," the agency said. That's especially true for patients battling seasonal hay fever symptoms.

For such patients, Seymour said, "there are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription."

But one expert in respiratory illness said the true extent of the danger from montelukast remains unclear, because other factors might be at play.

"These [psychiatric] issues are hard to quantify and may also result from steroid use, which is common in asthma," said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City.

Added to the boxed warning, patients who are prescribed montelukast will also get a special Medication Guide outlining potential risks, the FDA said.

More information

The American College of Allergy, Asthma and Immunology has more on hay fever.




Facebook

Amazon Smile

 

Children and Adult services are available now with no wait time.  

Please contact HBH at 860-548-0101, option 2.

 


powered by centersite dot net