Singulair suicide side effects to be reviewed by FDA
The FDA has released a statement regarding their investigation into a possible association between Singulair and suicides, suicidal thinking and unusual behavior changes. The drug regulators have requested additional information from Merck & Co., the manufacturer of the popular asthma medication, and they expect to complete their evaluation of the Singulair suicide side effects within the next nine months.
>>FDA Early Communication: Singulair Suicide Investigation
Singulair is a pill approved by the FDA for treatment of asthma and allergy symptoms. The medication works by controlling chemicals that are released during allergic reactions which may lead to inflammation, congestion and other allergy symptoms. In recent years, it has become one of the best selling medications in the world, with total sales of $4.3 billion in 2007, about three quarters of which came from prescriptions in the United States.
Since last October, the FDA has received several reports of suicide among users of Singulair, as well as other reports involving severe mood changes and suicidal behavior. Within the past year, Merck has added indications to the prescribing information about Singulair side effects which indicate that the drug could be associated with tremors, depression, suicidal thinking and anxiousness.
The FDA has requested Merck go back through adverse event reports received by the pharmaceutical company to take a closer look at the data. The agency will review available information to look for reports of behavior and mood changes, suicidal thoughts and suicides among Singulair users. After they have completed their review, the FDA will communicate any conclusions and recommendations to the public. This could include stronger warnings, restrictions on who can receive the medication or no regulatory actions at all.
Singulair is part of a class of medications known as leukotriene agents, and other similar medications in this class include Accolate (manufactured by AstraZeneca) and Zyflo (manufactured by Critical Therapeutics). As part of their review, the FDA will evaluate whether any suicide risk with Singulair may also be associated with Accolate, Zyflo and Zyflo CR. However, those medications have been taken by a very small number of people when compared to those who have been prescribed Singulair. The combined sales of these other medications in the U.S. was under $70 million last year, compared to $3.4 billion for Singulair sales in the U.S.
While the FDA continues their investigation of the Singulair suicide side effects, they have cautioned doctors to carefully monitor patients taking the drug for mood changes and signs of suicidal thoughts. The FDA has indicated that the early communication does not mean that there is definitely a relationship between Singulair side effects and suicides, but reports received have led the agency to take a closer look at this emerging safety issue. There is no indication that users should stop taking the medicine, and no prescription drug should be discontinued without first speaking with your doctor.
SINGULAIR SUICIDE LAWSUITS
The lawyers at Saiontz & Kirk, P.A. are closely monitoring the FDA’s investigation into the possible Singulair suicide side effects. If you, a friend or family member have suffered severe physical injury or death as a result of a suicide or suicide attempt while taking Singulair, review the legal options which may be available by requesting a free consultation.