The US Food and Drug Administration is evaluating data for a
potential link between some serious mood disorders affecting patients who take
Singulair manufactured by Merk & Co, Inc. and this drug. The action started as a response
to some reports received from doctors and patients.
Singulair is a leukotriene receptor antagonist with
mechanism of action similar to Accolate (zafirlukast). It has been marked in
the United States
for 10 years. Now millions of patients are using it as a remedy for stuffy
nose, sneezing and other allergy symptoms as well as asthma.
The FDA is taking into consideration a growing list of
medications for analyses, including antidepressants and treatments for
attention deficit disorder and epilepsy.
Usually, Singulair is prescribed in the treatment of asthma,
allergic rhinitis or for prevention of exercise-induced asthma.
Some reports show that it has been associated with suicidal
thinking or suicide itself.
But the announcement made by the FDA doesn’t imply forbidding
this drug from prescriptions. Information was updated and now it includes
alerts for adverse reactions such as tremor, depression, suicidal thinking, and
anxiousness.
“I think the fact that the FDA announced it is specifically
looking at this means it got more case reports of suicide than would have been
expected," J. Douglas Bremner, a psychiatrist and director of Emory
University's clinical neuroscience research unit said, quoted by the New Jersey
Business News. “So I think it is probably significant,” he added.
The FDA initiated a program that can be accessed online for
all those who want to report any incidence of the adverse reactions mentioned
above. Also, it advised patients that they shouldn’t stop taking Singulair
before talking to their doctor.