No, not yet.
But the U.S. Food and Drug Administration (FDA) today notified the maker of Singulair, a popular drug used to treat asthma, that it wanted more information and data about its use and suicide and suicidal thoughts.
According to a report at WebMD, “In response to inquiries received by the FDA, the FDA has asked Merck to evaluate Singulair study data for more information about suicidality and suicide. The FDA is also reviewing its postmarketing reports of behavior/mood changes, suicidality, and suicide in patients who took Singulair.”
The FDA said it is also reviewing reports of behavioral changes in patients taking similar drugs, including AstraZeneca Plc’s Accolate and Critical Therapeutics Inc’s Zyflo, but has not yet decided whether further investigation is needed.
All three drugs are known as leukotriene agents that work by controlling leukotrienes — chemicals in the body that are released during an allergic reaction and can lead to inflammation, congestion and other symptoms.
In a statement, Merck said its analysis of more than 11,000 patients in 40 clinical trials of Singulair found no reported suicides or suicidal thoughts or behavior.
The FDA suggested no one should go off of their medication before first talking to their doctor. Doctors should more closely monitor patients on one of these drugs for changes in mood or behavior, especially related to suicidal thoughts (especially in people who have no prior history of having any).
You can read more about the issue from this Reuters report on the FDA’s request about Singulair and suicide.
On April 23 2008, the FDA approved changes Merck made to the package insert that mentions agitation, depression, irritability and “suicidal thinking and behavior (including suicide).” The information is also on a Singulair website, but some pharmacists still dispense from older shipments delivered before the label changes.
On May 3 2008, The (Albany) Times Union published this account that stated:
FDA officials will collect personal stories of people experiencing unusual side effects while taking the allergy drug Singulair, a move that follows a meeting Friday with a Queensbury couple who blame the medication for prompting their son’s suicide.