The probe is still in its early stages, but federal health officials do not believe that asthma drugs are tied to suicide.
The Food and Drug Administration (FDA) looked at Merck’s Singulair and found that Merck data do not show any association. Dozens of company studies were submitted by Merck which says it has cooperated with the FDA and turned over extensive company records.
Last March a handful of reports indicated that taking Singulair, Astra Zeneca PLC’s Accolate, and Zyflo could result in suicidal behavior and mood changes.
Merck stresses that none of the 11,000 patients enrolled in their drug trials has killed themselves and the FDA says this is an effort to inform the public, no casual relationship has been established between the drug and suicide.
Recently the drug maker was required to update its label warning of suicidal thinking and behavior.
The label now reads: "The following additional adverse reactions have been reported in post-marketing use: Psychiatric disorders: agitation including aggressive behavior, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor."
An Albany, New York area couple clamed their 15-year-old’s death last August on his switch to the allergy medication Singulair from Allegra. But Merck stresses tis and others are anecdotal reports from consumers, not data that the company has observed.
In an effort to have an “Early Communication” with the public about any safety concerns, the FDA decided to act more quickly to notify the public before they draw any conclusions.
That is in response to criticism that the FDA acted too slowly in informing the public about another Merck medication, Vioxx, which was eventually removed from the market after it caused thousands of heart attacks and strokes.
Further studies into mood disorders resulting from the asthma therapies will continue.
Singulair is a best seller for Merck with sales exceeding $4 billion. #