The FDA has asked Merck to look at Singulair study data for more information about suicidality and suicide. The agency itself is reviewing post-marketing reports of adverse events.
In its statement, Merck detailed the nature of those adverse events. "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," the statement read. "Additionally, in a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, clinical trials that compared Singulair with other active agents to treat asthma [which included over 3,900 adults and children who were treated with Singulair and over 3,400 who were treated with other asthma therapies], there was one patient who attempted suicide who received Singulair, and there were three patients who attempted suicide who received other asthma therapies [including inhaled corticosteroids and long-acting beta-agonists]."
The FDA noted it was also looking into whether other related drugs, such as Accolate, Zyflo and Zyflo CR need to be investigated as well.
"Due to the complexity of the analyses," the FDA said, it anticipates that it may take up to nine months to complete the ongoing evaluations.
Experts pointed out that, in the meantime, asthma sufferers need to determine with their doctors whether Singulair is the best choice of treatment for them.
"[Patients need] to define what they're taking it for," said Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas. "In some instances, patients may be prescribed Singulair by itself for management of their asthma, and the expert panel guidelines recommend inhaled steroids as the drug of choice for management of asthma as the first line. So if they're still having problems with asthma, they should check with their prescribing physician regarding this."
