The FDA Warned an Asthma Drug Could Induce Despair. Many Were Never Told

January 24, 2024 9:45 PM

The FDA Warned an Asthma Drug Could Induce Despair. Many Were Never Told
posted by chariot pulled by cassowaries (22 comments total)

Terrifying. Reminds me of the accounts of side-effects from notorious anti-malaria drugs I've been told should be banned.
posted by in_lieu_of_fiction at 12:11 AM on January 25

Oh God. Yes. This drug.
I am allergic to cats, but my wife came with one, as it were, and for *years* I would wake up in the morning with a terrible cough and congestion. Eventually an allergist put me on this stuff. It cleared my lungs up completely for the week I took it. I know this, because I would wake up every morning literally screaming. It’s incredibly good at its job, and it’s also utterly awful.
posted by DangerIsMyMiddleName at 2:14 AM on January 25 [9 favorites]

I work in food and drug regulation and I think this is a key note in the article: "Rarely are approved drugs with known side effects fully barred from sale."

I would add to that another statement that startles many people who don't work in these industries: Rarely are drugs approved with an expectation that their established beneficial effects are going to outweight their largely unknown longer-term adverse effects.

We (as in, humanity) don't have drug development and approval systems that were designed. THey weren't even optimized, like the way that natural selection leaves odd evolutionary tangents in place but always as an appendix to developing systems that work really well for some given set of conditions. No, we have a set of systems that do not interact well, have been built by sloppy accretion, and frequently are in direct opposition with one another. It's insane, expensive, and terrible at its task... but it's there and almost everyone's afraid to mess with it because of the politics and money at stake.

The moral of the sotry isn't a depressing one, I don't think. People are working on this and it's improving over time. IThe moral of the story is, do yourselves a favor and take the time to read that little package insert that comes with anything you buy that's regulated as a drug. It doesn't just tell you what we know to look out for, it also tells you just how much to temper your expectations of what the manufacturer is legally allowed to claim as a benefit of taking it. And that is... sometimes bizarrely less clear than what you hear on the commercials.
posted by late afternoon dreaming hotel at 3:49 AM on January 25 [10 favorites]

I agree with ladh's comment except the below

The moral of the story is, do yourselves a favor and take the time to read that little package insert that comes with anything you buy that's regulated as a drug

There are so many of these warnings on drugs (like safety data sheets in chemistry), it becomes a meaningless case of "read the CYA legalese" after a while. But more importantly: It shouldn't be a nonexperts job to do this kind of analysis!!!. That's what the regulation of everyone prior to the point of prescription is for.
posted by lalochezia at 4:55 AM on January 25 [20 favorites]

I read that headline and thought, "Oh, well this explains so much!" Then I read the article and thought, "Oh. That's not the drug I take. Back to the drawing board."
posted by brundlefly at 5:23 AM on January 25 [2 favorites]

I took Singulair for years and was unaware of this. Also had depression off and on. Fortunately I stopped taking it because it did absolutely nothing for asthma...
posted by mmoncur at 5:24 AM on January 25 [1 favorite]

It's so weird (in the US) that if you're pregnant, any number of very important medications are verboten because they don't know if and how it'll affect a fetus. It seems to be a moral/ethical thing, impossible to do studies, etc. Many a doctor will fully expect you to immediately stop taking medication regardless of how vital it is to your wellbeing because of the baby. But children don't seem to get this level of concern and there seems less of a moral/ethical quandary with giving them potentially dangerous medication. Which I don't understand, considering how their brains are very actively developing. Shouldn't side effects in meds kids are taking be given far more weight than it would for adults?


What I'm saying is, ya mess up one fetus and everyone makes a fuss but ya drive a few kids to suicide and that's alright?
posted by Baethan at 5:37 AM on January 25 [14 favorites]

My partner takes this, and it's first on the list for her to talk about at her next medical appointment. I don't know how it was publicized, but we were completely unaware until the article came out. She isn't feeling any of the ill effects, so we're not too worried, but there will definitely be a conversation about whether or not there might be something better to try that doesn't come with this kind of baggage.

The stories of suicide in the piece were so sad.
posted by Dip Flash at 6:56 AM on January 25

Most asthma drugs seem to have anxiety as part of the package. I had an eighth grade student once whose mother tried to keep him from having to read an Agatha Christie novel in English class. He was having bad nightmares about it, and worrying about it during the day. He had been my advisee in sixth grade, so I asked how his asthma was. Apparently it was really bad and he was taking more meds than usual, so I gently suggested a visit to his doctor. I heard nothing more from her after that.

Why did I know to ask that? Because I too have asthma. Being able to breathe is wonderful, but luckily my asthma is episodic so I don't have to stay on the meds too long because being even more anxious than I already am is pretty terrible.
posted by Peach at 7:09 AM on January 25 [2 favorites]

I came to see if this is any of the Asthma drugs I use. It's not. But thanks Peach, I needed to know that. I started to have problems with anxiety when my living situation turned bad. I have no doubt that this was a part of the picture. Thankfully, I'm on meds now for my ADHD, which, hilariously, does nothing for it, but does seem to act as an anti anxiety med. Crazy old world.
posted by evilDoug at 8:08 AM on January 25 [1 favorite]

The drug is "Singulair, also known by its generic name, montelukast," I say for my fellow asthmatics who were panicking. That should be in the headline!
posted by The corpse in the library at 8:14 AM on January 25 [6 favorites]

I was very recently prescribed Singulair. My doctor specifically mentioned the black-box warning and the reasons for it, indicating that it mostly affected children but that I should be aware. So at least some medical professionals have been getting the memos.
posted by jackbishop at 8:19 AM on January 25 [2 favorites]

That should be in the headline!

Agreed, especially since it's a possibly-paywalled NYTimes article. Thankfully, I'm unfamiliar with this one. The asthma meds I know are Albuterol for attacks, and an ever-changing line of cortisones to prevent them; currently I'm on something called Alvesco.
posted by Rash at 8:31 AM on January 25

Cool cool cool. Had no idea about this. I've been taking Singulair for my entire adult life, 20 years. I've also been dealing with depression for the last five, so seems unlikely but not impossible that that's linked? Thanks for posting this article -- definitely going to be following up with my PCP and my psychiatrist.

(I also took one of the "notorious anti-malaria" drugs while I studied abroad 15 years ago. That at least I did get a warning of the potentially severe psychiatric side effects, which I thankfully avoided other than incredibly vivid -- but not traumatic -- dreams.)
posted by bassooner at 8:47 AM on January 25 [2 favorites]

I've been taking Singulair for at least fifteen years, and had no idea about this. I read the broadsides at the time, but who reads the broadsides on a drug you've been taking for more than a decade, every single time you get a refill? Not me!

Just now, I checked my bottle, and there is no black border, just a very tiny note to call my doctor if I notice any mood changes, sadness, depression or fear. That's it!

I have nightmares, which we chalked up to PTSD. I have anxiety and pure O intrusive thoughts. I have had bouts of depression throughout my life. And now I have to wonder how much of that is a product of trauma and mental illness, and how much might be my allergy medicine. Fantastic!
posted by headspace at 3:07 PM on January 25 [3 favorites]

I did a trial of montelukast and was lucky enough to go in knowing it could cause suicidality. My mental health tanked by day three: I woke up in a dark cloud, tearful, questioning all my relationships and life choices. I discontinued it and was back to normal in 48 hours. Eughh.. I'm shuddering just thinking about it. The psychiatric effects are truly nasty if you're prone!
posted by lloquat at 4:16 PM on January 25 [2 favorites]

Only briefly used Singulair myself as I am one of those people for whom it makes asthma much worse. That was scary enough. I’m lucky my asthma is episodic and occasional.
posted by Peach at 6:41 PM on January 25

Well, this may explain alot about my adolescence.

This is totally tangential but kind of on topic:

I remember the time after a few albutorol treatments and a salumedrol injection that my university clinic dragged me in front of the psychiatrist I saw for anxiety. I was so anxious because I couldn't breathe, and the side effects of steriod medications on my brain are absolutely hellish. I was basically there to ask for a doctor's note for school because I couldn't walk to classes or focus. The doctor was giving me a little pushback and I burst into tears. Also my hands shake when I use albultorol with any regularity.

Which was embarrassing but at least he believed me and knew me without those meds. I hope that he sent out an email reminding them of the side effects of asthma medication. I certainly never forgot being so upset about my asthma symptoms and medication side effects that my doctor walked me to see a psychiatrist.
posted by AlexiaSky at 7:40 PM on January 25 [1 favorite]

Thanks for this post, and for the comments as well. Not to derail, but side-railing: this is the first I’ve heard about "notorious anti-malaria" drugs. Three websites later and I now may have a better understanding of at least some of my experiences while being treated for SLE. Further research: some of these side effects are evidenced years later? I’ll be having a frank discussion with my rheumatologist. Meanwhile, thanks yet again metafilter for informing me of something I didn’t know that I needed to know.
posted by Nancy_LockIsLit_Palmer at 10:33 PM on January 25 [1 favorite]

I used Singulair for years, for low level asthma, until it cost too much ($300 a month, hadn’t gone generic yet). I talked to my new doctor about the cost and they took me off it and seemed to indicate that I shouldn’t have been on it in the first place. I didn’t have childhood asthma, had developed it after a bout of walking pneumonia.
posted by vitabellosi at 4:05 AM on January 27

I started taking singulair being fully aware of the potential side effects. On r/asthma, it's notorious for this. I was nervous, b/c I react weirdly to lots of drugs, and I have pre-existing mental health problems, mainly C-PTSD/DID from severe childhood trauma.

It was a miracle drug for me. I have very difficult to control asthma, with paradoxical reactions to ALL bronchodilators (albuterol, LABAs, atrovent...literally every single one, which is apparently almost unheard of.)

I also do inhaled steroids and oral prednisone* for really bad flairs, but singulair was the first medication that really worked for me.

So patients should definitely be informed, doctors should absolutely inform patients and monitor this stuff, but I am incredibly glad singulair is available for me to take. Although my doctors did not warn me about singulair's mental health side effects - I just happened to be aware of them for all my research.

*Prednisone is another med i was terrified of b/c of the potential side effects, including mental health side effects. It actually helps stabilize my mental health. *shrugs* Turns out being able to breathe is also a mental health benefit!
posted by litera scripta manet at 11:34 AM on January 27 [1 favorite]

It does seem with singulair, there should be a much higher bar if not an outright ban in using it with children, given the currently available data. (I started taking it when I was in my early 30s.)

I am curious why the effects are so much more pronounced in children. But either way, I feel like for kids, it seems like it should only be tried in kids if the choice is between singulair or long term oral corticosteroids for asthma control. And even then, only should be used with significant oversight.
posted by litera scripta manet at 11:44 AM on January 27