An FDA investigation has discovered a possible link between Merck’s Singulair and suicide rates. Singulair is an allergy drug that was used by millions of people last year, giving the maker Merck a profit of 4.3 billion dollars. The FDA is using reports to conduct their investigation and not clinical studies, which had Merck on the defense. Merck has stated that the patients enrolled in the 40 trials held for the allergy drug never committed suicide.
The possibility of suicide in patients taking Singulair is rare, says Merck, but is put on the warning label as a precaution. For those who currently take the drug and are worried, they should seek a doctor before they decide to stop taking Singulair. Doctors play a big role in this story because they will need to watch patients for changes in mood and behavior which is not common with the massive prescriptions written for the allergy drug.
The FDA has yet to establish a solid link between the allergy medicine and suicide rates, but the FDA feels that because of the three of four reported suicides before October of last year, there is merit for the agency to explore all possibilities. The FDA reports that it could take nine months or more before any conclusion can be drawn.
Because of the popularity of Singulair, the company has had to change the warning labels four times, even though it had already listed suicidal thoughts and behavior as side effects of the drug. In the
Clinical trials, the most common side effects were flu, headaches, and cough. There were not suicidal thoughts or behavior reported in any of Merck’s clinical trials.
The FDA is not just targeting Merck and Singluair. The FDA is also checking up on rival drugs such as Zyflo and Accolate, which may contain the same drug. These medicines do not carry a warning label for suicide.
