Breaking news volgens elsevier:Er is door de FDA in de VS een mogelijke relatie gevonden tussen het gebruik van singulair en suicidaliteit. De FDA heeft aan Merck, producent van singulair, gevraagd om de data van singuair nogmaals tegen het licht te houden om te zien of het vermoeden waar is. Mensen moeten nu niet met singulair gaan stoppen volgens de FDA. We moeten eerst nader onderzoek afwachten.
(Bron: elsevier/Acep news)”The Food and Drug Administration issued an “early communication” to health care professionals on March 27 that it is reviewing postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who have taken the asthma and allergy medication montelukast (Singulair), although the agency declined to say how many reports it has received.An initial review of clinical trial data found no evidence of an association with mood changes, according to Dr. Philip. “In a cumulative analysis recently provided to the FDA of Merck’s randomized, double blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with Singulair, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received Singulair,” said the company’s statement.The FDA has asked Merck to review all its clinical data for evidence of suicidality or suicide. And the agency said it will review the postmarketing reports it has received on behavior and mood changes, suicidality, and suicide. The FDA said its investigation will take 9 months.In the meantime, patients should not stop taking Singulair, said the FDA and Dr. Philip. The agency did urge physicians to monitor patients for signs of suicidality and other psychiatric events. ”
