MONTELUKAST - ALERTA [MedWatch]

Singulair (montelukast)

Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
[UPDATE 01/13/2009] FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.

[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.

[January 13, 2009 - Follow-up to the March 27, 2008 Communication - FDA]
[March 27, 2008 - Early Communication About an Ongoing Safety Review - FDA]

Early Communication About an Ongoing Safety Review of Montelukast (Singulair)

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

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.

Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program

on-line at [www.fda.gov/medwatch/report.htm];
by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
faxing the form to 1-800-FDA-0178; or
by phone at 1-800-332-1088

NOTA DEL BLOG: LOS ALERTAS DE LA FDA SE EXPRESAN TAL CUAL HAN SIDO INFORMADOS Y EDITADOS, EN IDIOMA INGLÉS DE MODO DE NO TERGIVERSAR EL SENTIDO ORIGINAL QUE SE PRETENDE TRANSMITIR. NO OBSTANTE ELLO, EL PROFESIONAL DEL EQUIPO DE SALUD QUE SOLICITE UNA TRADUCCIÓN DE ESTE MATERIAL, PREVIA ACREDITACIÓN DE SU CONDICIÓN, LA RECIBIRÁ DE MANERA GRATUITA ENVIÁNDOSE LUEGO COPIA DE LA TRADUCCIÓN A LA PROPIA FDA DE MODO QUE LA MISMA SE INCORPORE A LA BASE DE DATOS EN IDIOMA ESPAÑOL, EN LOS ESTADOS UNIDOS DE NORTEAMÉRICA.