Exclusive: US FDA finds widely used asthma drug impacts the brain

[BumRushDaShow]

Source: Reuters

November 22, 2024 10:58 AM EST Updated 7 hours ago


Nov 22 (Reuters) - U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co (MRK.N) may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters. The researchers found that the drug, sold under the brand name Singulair and generically as montelukast, attaches to multiple brain receptors critical to psychiatric functioning.

Singulair was a blockbuster product for Merck after its launch in 1998, offering relief in a pill as an alternative to an inhaler. In early advertising, the company said the side effects were so benign that they were "similar to a sugar pill," while the label said any distribution in the brain was "minimal." Generic versions are still prescribed to millions of adults and children every year.

But by 2019, thousands of reports of neuropsychiatric episodes, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and in the U.S. Food and Drug Administration’s tracking system. Such “adverse event” reports do not prove a causal link between a medicine and a side effect, but are used by the FDA to determine whether more study of a drug’s risks are warranted.

After years of analysis, the reports and new scientific research led the FDA in 2020 to add a "black box" warning to the montelukast prescribing label, flagging serious mental health risks like suicidal thinking or actions. The agency also convened a group of internal experts around the same time to look into why the drug might trigger neuropsychiatric side effects. The results of the group's work, which are preliminary and have not been previously reported or released publicly, were presented to a limited audience at the American College of Toxicology meeting in Austin, Texas on Wednesday.

Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-finds-widely-used-asthma-drug-impacts-brain-2024-11-22/

[Ponietz]

1. That shit is Rx'd for allergies too

[Mike 03]

2. For some reason (actually I know the reason) many people

are suddenly Googling "Is Singulair an antihistamine?"

Singulair is not an antihistamine. It is a leukotriene receptor antagonist that works by blocking leukotrienes that are responsible for lungs inflammation [SIC] and airway narrowing. Antihistamines work by blocking a different substance called histamine

From BuzzRX.com, "Singulair Frequently Asked Questions."

(I.e., Singulair has a different mechanism of action from other allergy and maybe asthmas drugs)

[Hekate]

3. Just great

[summer_in_TX]

4. I've taken Singulair/Montelukast for years for my asthma, with no ill effects.

But it is seriously disconcerting to learn it can have serious mental health impacts. It's just one of several meds I take to manage my asthma. In fact I just took my dose for today for bed.

[LauraInLA]

5. I'm still taking Singulair and the Stiolto inhaler. The biological injection Fasenra has allowed me to

discontinue the Brio Elliott inhaler, Xopenex, Mucinex, etc. But my pulmonologist still thinks the Singulair is essential .

[summer_in_TX]

6. Fasenra has helped me a lot.

I haven’t had bronchitis in the last three years. Have you had any mental health effect that could be from being on Singulair?

I wonder. Can we assume that it is safe for those of us who have been on it for years and years without any mental health effect?

[LauraInLA]

7. I haven't had any mental health issues I could attribute to Singulair. But I agree -- just because I've

been lucky, it doesn’t follow that Singulair may clash with some people’s brain chemistry. It’s a real shame.