The FDA said yesterday it is looking into a possible association between Merck’s allergy and asthma drug Singulair and suicide. The FDA has received reports of mood changes, suicidal ideation and suicide in patients who have taken Singulair. Trying to get out on the front of the curve with its package insert, Merck has previously updated Singular’s drug labeling four times to include potential risks of tremors, anxiousness, depression and suicidal behavior that has been reported in some users of Singulair.
To call Singulair a popular drug is an understatement. Singulair is Merck’s biggest selling drug and one of the world’s top selling medicines with $4.3 billion in sales. Singulair is also a leukotriene receptor antagonist. These types of drugs have previously been linked to suicidal ideation and suicide. Two similar drugs, AstraZeneca’s Accolate and Critical Therapeutics’s Zyflo, will also be reviewed by the FDA. Neither of these drugs have suicide warnings.
Singulair/suicide litigation just might be the next big mass tort. But I doubt it. Unfortunately, 40,000 people a year commit suicide and when you have a drug like Singulair that is used by millions, some of those people are going to take Singulair and commit suicide. Some will even take Singulair and commit suicide in close temporal relationship with the initiation of the drug which really leads people to assume that it must be the drug. But it does not automatically follow that Singulair causes suicide. That remains to be seen and my guess is that Singulair does not cause suicidal behavior. Either way, it is nice to see the FDA is trying to get out in front a potential risk (for once). This is probably a byproduct of the errors that the FDA made with Chantix, where the FDA rushed Chantix – a drug that alters mood – onto the market without fully assessing the suicide risk. .