The FDA announced that it was investigating a possible link between increased risk of suicide and the asthma drug Singulair marketed by Merck & Co. It was Merck’s number one selling product last year to people 17 years old and younger, posting sales of $4.3 billion. The FDA noted that asthma patients taking Singulair should not stop taking the drug until they have spoken with a doctor.
Although the reports of suicide have come to the company anecdotally, and the number is believed to be small, Merck has been working closely with the FDA over the last year to make appropriate changes to Singulair’s label. The new labeling changes will note that Singulair may increase “tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness.”
The FDA is also looking into whether other related drugs including Accolate, Zyflo, and Zyflo CR should be investigated for potential risks. Singulair is a leukotriene receptor antagonist which targets parts of the inflammatory process in the body. It is prescribed to prevent exercise-induced asthma, as well as the symptoms of allergic rhinitis, or symptoms which occur primarily in the nose and eyes.
In a random, double-blind, and placebo-controlled clinical trial, Merck looked at over 11,000 adults and children who were treated with Singulair. In over 40 studies, there were no reports of suicidal thinking or behavior. In a similar trial that compared Singulair with other asthma medicine, one patient who received Singular attempted suicide, and three other patients who took other asthma medications attempted suicide.
Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas, said that he has not seen any increase in psychiatric behavior in people taking Singulair, but noted that some users suffered nightmares after beginning the drug.