Reuters has reported that the FDA is investgating Merck's Singulair asthma drug for possible links to suicidal behavior and suicide.
According to Reuters: The FDA said it is reviewing the asthma medication after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took Singulair.
"No causal relationship has been established, the FDA said."
The FDA Web site said:
"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)."
"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)."
That's pretty scary stuff!
The report also states: "No definite link to the drug has been established and the agency did not say how many post-marketing reports it had received. Merck declined to say how many reports had been submitted, but said they involved both adults and children."
Singulair is the number one-selling drug among people aged 17 and younger. It posted sales of $4.3 billion just last year, according to the Associated Press, making it Merck & Co.'s top-selling product.
It will be a long time before the FDA will complete it's review of Singulair and similar drugs -- up to 9 months, according to Reuters.
The FDA said is also reviewing reports of behavioral changes in patients taking AstraZeneca Plc's Accolate and Critical Therapeutics Inc's Zyflo, according to Reuters, but the agency has not yet decided whether further investigation is needed.
All three drugs work by controlling leukotrienes. Leukotrienes are powerful immune system factors that, in excess, produce damaging chemicals that can cause inflammation and spasms in the airways of asthmatics. Leukotrienes medications are used for prevention and not for treating acute asthma attacks
Do any of you take Singulair?
Do any of you take Accolate or Zyflo?
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Published On: March 28, 2008