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montelukast FDA Alerts

The FDA Alert(s) below may be specifically about montelukast or relate to a group or class of drugs which include montelukast.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for montelukast

FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast

Mar 4, 2020

Audience: Patient, Health Professional, Pharmacy

March 4, 2020 -- The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever). The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.

As noted in a new Drug Safety Communication issued today, the warning follows the FDA’s review of available data regarding continued reports of neuropsychiatric events with montelukast, such as agitation, depression, sleeping problems, and suicidal thoughts and actions. The Drug Safety Communication includes recommendations for health care professionals and patients and a summary of the data that led to these warnings.

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. 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,” said Sally Seymour, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “With today’s action, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions. Importantly, 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.”

The FDA updated the product labeling in 2008 to include information about neuropsychiatric events reported with use of montelukast. In response to continued reports of suicide and other adverse events, the FDA evaluated available data regarding the risk of neuropsychiatric events, including reports submitted through the FDA Adverse Event Reporting System (FAERS) and observational studies in the published literature. The FDA also conducted an observational study using data in the Sentinel Distributed Database and presented the findings at an FDA advisory committee meeting in 2019.

As part of its review, the FDA re-evaluated the benefits and risks of montelukast as the treatment landscape has evolved since the drug was first approved in 1998. Based upon this 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. For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies.

In addition to the boxed warning, the FDA is also requiring a new Medication Guide to be given to patients with each montelukast prescription.

Health care professionals and patients should report side effects from montelukast to the FDA’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

Mar 4, 2020

Audience: Patient, Health Professional, Pharmacy, Allergy and Immunology

ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. FDA is taking this action after a review of available information that led us to reevaluate the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.

BACKGROUND: Montelukast is FDA-approved for asthma and allergies. It is a prescription medicine approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children 1 year and older. It is approved to prevent exercise-induced asthma in patients 6 years and older. Montelukast is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older.

RECOMMENDATION: Patients should talk with your health care professional about: 

  • the benefits and risks of montelukast, as many other safe and effective allergy medicines are widely available.
  • any history of mental illness before starting treatment.

Health Professionals should:

  • Ask patients about any history of psychiatric illness prior to initiating treatment.
  • Consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine.
  • Advise all patients of the risk of neuropsychiatric events when prescribing montelukast. Warnings about these side effects are included in the existing prescribing information; however, many health care professionals and patients/caregivers are not aware of this risk, and suicides and other adverse events continue to be reported.
  • Advise patients and parents/caregivers that the patient should stop taking montelukast and contact a health care professional immediately if changes in behavior or new neuropsychiatric symptoms, suicidal thoughts or behavior occur.
  • Monitor all patients treated with montelukast for neuropsychiatric symptoms. Events have occurred in patients with and without pre-existing psychiatric disease.
  • Encourage patients and parents/caregivers to read the Medication Guide they receive with their montelukast prescriptions, which explains the safety risks and provides other important information.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178

Source: FDA

FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in Bottles

Aug 31, 2018

Audience: Consumer, Health Professional, Pharmacy

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus. The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately.

This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

“We want to ensure that patients who take montelukast are aware of this recall due to the serious risks associated with taking losartan in its place,” said Donald D. Ashley J.D., director of the office of compliance in the FDA’s center for drug evaluation and research. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma. It is also used to prevent bronchospasm (breathing difficulties) during exercise and to treat the symptoms of seasonal and perennial allergic rhinitis. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs) which work by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.

Losartan is often used alone or in combination with other medications to treat high blood pressure. Losartan is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart).

Patients should contact their health care provider or pharmacist to determine if their medicine has been recalled. Patients should also look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with “I” on one side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on one side and the number “5” imprinted on the reverse.

Recalled lots of montelukast sodium tablets, USP 10mg have the following information:

  • Label: Montelukast Sodium Tablets 10 mg 30 ct
  • Lot number: MON17384
  • Expiration date: 12/31/2019
  • NDC: 31722-726-30

To date, Camber has not received adverse event reports associated with this recall. The FDA encourages health care professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online at www.accessdata.fda.gov/scripts/medwatch/index.cfm; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Singulair (montelukast)

Mar 27, 2008

Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients

[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.  Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations.  As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

[March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]

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