The U.S. health regulator said Thursday that it is investigating a possible link between the use of Merck's allergy drug Singulair and suicide.
Singulair is Merck's best-selling drug to treat asthma and the symptoms of allergic rhinitis. The U.S. Food and Drug Administration (FDA) said Thursday in a posting on its website that it is reviewing the post marketing reports it has received of behavior and mood changes, suicidality (suicidal thinking and behavior) and suicide in patients who took Singulair.
FDA stressed that the information about the "ongoing" safety review on Singulair does not mean that FDA has concluded there is "a causal relationship" between the drug product and the emerging safety issue.
For now, FDA is not advising health care professionals to discontinue prescribing this product. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information.
However, FDA said healthcare professionals and caregivers should monitor patients taking Singulair for suicidality and changes in behavior and mood.
Over the past year, Merck has updated the prescribing information and patient information for Singulair to include the reported adverse events which include tremor, depression, anxiousness and suicidality.
FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. Due to the complexity of the analyses, FDA said that it may take up to 9 months to complete the ongoing evaluations.
Source:Xinhua
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