Adverse Event Reporting News - FDA reviewing safety of Merck, Mylan drugs
FDA March 27 announced it is investigating a possible link between suicidal behavior and the use of several popular asthma drugs, including Merck’s Singulair and Mylan Laboratories’ Zyflo.
Singulair is a medicine in the drug class known as leukotriene receptor antagonists, 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, Merck has updated the prescribing information and patient information for Singulair to include several post-marketing adverse events: tremor, depression, suicidality and anxiousness.
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Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and to 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 has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. The agency is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.
Other leukotriene modifying medications include Accolate (zafirlukast), which is also a leukotriene receptor antagonist, and Zyflo and Zyflo CR (zileuton), a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took these drugs, as well, and will assess whether further investigation is warranted.
Due to the complexity of the analyses, FDA anticipates that it may take up to nine months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
FDA warned that patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, health care professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
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