Montelukast: Beyond the Black Box

Print Friendly, PDF & Email
May 20, 2020 | 29 Comments


  1. As usual a truthful narration of a fight that continues…thank you for following this and thank you Laura for putting it so elegantly on paper…

  2. FDA UPDATE | MAY 2020 – in ACP Internist –

    Stronger warning for montelukast; COVID-19 action -…. details on recent recalls, warnings, and approvals.
    Strengthened boxed warning for montelukast (Singulair and generics). The FDA is strengthening existing warnings about serious behavior and mood-related changes with the asthma and allergy drug based on its re-evaluation of the drug’s benefits and risks.
    While the prescribing information had previously included warnings about mental health side effects, including suicidal thoughts or actions, many clinicians, patients, and caregivers were not aware of this risk, the FDA said.

  3. Well done and thank you for your work. IMHO, perhaps the effects would have been acknowledged earlier if prescribing physicians monitor patient side effects and were mandated reporters of medications adverse side effects. Technology today can certainly support such a system and provide the FDA with a wealth of drug safety information.

  4. Who would have thought what a huge impact removing the word “minimal” would have? However most consumers won’t notice- unless they added the word “substantial” in its place which we all know won’t ever happen. The word “minimal” being on there for years is what caused us to be dismissed by doctor after doctor when my son basically became disabled 3 years ago, and worsened for months after stopping. I wish we would get an apology instead of the laughing on top of multiple dismissals when my son was in severe psychiatric distress. Just heartbreaking for him and so many that went through so much pain and agony from
    montelukast. The black box is a great first step but the true story is what is highlighted in this article. Thank you Laura!

    • Annie,

      I have just re-read the comment you refer to above, thank you.

      My words were based on the tragedy of misdiagnosed, SSRI induced AKATHISIA and the serial cascade of psychotropic drugging, serial injury, and routine, serial misdiagnosis of ADRs which are still life changing, and cause intense suffering many years later.
      Our (medical) family lost the healthy, joyous personality of, and delight in our younger adult daughter as a direct result of lack of prescriber awareness of akathisia.
      She has never, at any time, had any “M.H.” illness or condition.

      There is something of an irony here.
      Our other adult daughter uses inhalers for what is thought to be asthma.

      A recent (caring) GP consultation lead to the advice:

      “I think we may need to change your inhaler”.

      He then tapped the keyboard, and presumably referring to “Guidelines” said:

      “I’m supposed to prescribe Montelukast”.

      No thank you, said our daughter, alerted thanks to RxISK to the neurotoxicity, and in particular the risk of montelukast induced behavioural toxicity with the terrifying potential for further “Mental Health” misdiagnosis.

      Perplexed, but as a genuine question, he asked why she believed it to be too dangerous.

      A brief reference to her sister’s tragedy sufficed. An alternative inhaler was helpful.

      We may well have lost our other daughter were it not for RxISK.

  5. Thank you for posting Laura Marotta’s comments and research. My sons are affected by this drug and we still struggle with the withdrawal syndrome.

  6. Why are so many medicines inducing so many health maladies?
    This was something I did not take into consideration or fully acknowledge, until an adverse event happened to me?
    It leaves me thinking that some pharmaceutical companies are still taking ‘shortcuts’ that end up being very dangerous in the end for so many patients.
    Why do historic buildings built many centuries ago withstand the test of time?
    I assume they did everything thoroughly and scrupulously back then.
    Everything was done on the square.
    Despite the lack of modern technology, those who created these magnificent masterpieces, made sure that what they were building was solid structures.
    Today, many buildings that are being built are rushed.
    Some materials that are being used are inferior, (imported from countries that don’t have product safety standards, which could turn out to be toxic and deleterious to ones health.
    Just like they used asbestos, in homes from 1920-1984, what makes one assume the materials they use now are not toxic?
    So I am assuming the same would happen in the pharmaceutical industry.
    If people don’t come forward with complaints or clinicians are too afraid to report an incident due to a medicine they have prescribed, how can a medicine that is inducing so much harm be taken off the market or have a black box warning?
    For instance, experts have known about the deleterious implications of benzodiazepines for at least 50 years and still till this date, was has evolved from this disgraceful scandal?

    According to an article:

    Drug and vaccine manufacturer Merck was caught red-handed by two of its own scientists faking vaccine efficacy data by spiking blood samples with animal antibodies. GlaxoSmithKline has just been fined a whopping $3 billion for bribing doctors, lying to the FDA, hiding clinical trial data and fraudulent marketing. Pfizer, meanwhile has been sued by the nation’s pharmacy retailers for what is alleged as an “overarching anticompetitive scheme” to keep generic cholesterol drugs off the market and thereby boost its own profits.

    The picture that’s emerging is one of a criminal drug industry that has turned to mafia tactics in the absence of any real science that would prove their products to be safe or effective. The emergence of this extraordinary evidence of bribery, scientific fraud, lying to regulators and monopolistic practices that harm consumers is also making all those doctors and “skeptics” who defended Big Pharma and vaccines eat their words.

    To defend Big Pharma today is to defend a cabal of criminal corporations that have proven they will do anything — absolutely anything — to keep their profits rolling in. It makes no difference who they have to bribe, what studies they have to falsify, or who has to be threatened into silence. They will stop at nothing to expand their profit base, even if it means harming (or killing) countless innocents.

    There has to be a public enquiry into unethical and immoral practices of drug companies.
    This DIRTY business has to STOP.
    According to U.S. federal investigators, GlaxoSmithKline (…):

    • Routinely bribed doctors with luxury vacations and paid speaking gigs
    • Fabricated drug safety data and lied to the FDA
    • Defrauded Medicare and Medicaid out of billions
    • Deceived regulators about the effectiveness of its drugs
    • Relied on its deceptive practices to earn billions of dollars selling potentially dangerous drugs to unsuspecting consumers and medical patients
    The Administrations who run the show have no interest whatsoever, in any JUSTICE.
    So why are we being made aware of all this disgusting carry on?
    Why are the LAWS protecting these criminals?
    If Big Pharma would falsify data on vaccines, what else would the industry do?
    The people who eat out of their palms, are no better?
    Why are the crooks getting away with murder?
    The article states:

    I’ll tell you why, and you’re not gonna like the answer: Because America has become a nation run by crooks for the benefit of crooks. It’s one big country club, and as comedian George Carlin used to say, “YOU ain’t in it!”

    • Lets stop pretending that these drug companies that deliberately lie, distort the data, bribe doctors, and all the rest of their dodgy dealings, so that they can make billions of dollars, while knowing their products will likely harm and kill many thousands, are anything but serious and dangerous criminals.

      In fact I would say they are a lot worse than the average serial killer.

      Often serial killers come from disadvantaged backgrounds, haven’t had the advantage of an education, and have a long history of being abused. Not that this excuses their behaviour, but it goes someway to explaining it.

      With the drug companies we are talking about educated people who for the most part have had a reasonably good start in life, who know the difference between right and wrong, and still knowingly choose to harm and kill thousands of people for profit.

      There is absolutely no excuse for it whatsoever, and it is a form of mass murder.

      Also serial killers usually kill well below 100 people, which of course is still horrible, but when it comes to the drug companies, we are talking about hundreds of thousands killed, probably in the multi millions, if we were to take all deaths into account since the drug companies have been around.

      While a serial killer might be a danger to the populace in a city or a relatively local geographical area, the harm and deaths caused by the drug companies stretches right across the globe, and potentially could affect anyone and everyone. They are a very real and serious threat to the whole of humanity itself.

      The whole situation is very morally repugnant, and if there was any real justice, then there should be a lot of people serving long prison sentences.

      End of!

  7. Thank you for posting. My kids took this drug for 3 years, with no warnings from doctors, nurses or pharmacists. The medical community needs to understand that thousands are suffering LONG TERM CONSEQUENCES from this drug, long after they stop taking it! And who in the medical field helps you recover???? No one. There are no “recovery treatments.” Most doctors don’t even believe parents because they believe that side effects are rare. We are damaging children, not only for the short term, but also the long term. What happened to “do no harm?”

  8. Why not let the patient sign up a consent form before taking this drug? The side effects mentioned in this form may include suicidal action, suicidal thoughts, depression, anxiety, hallucination, OCD, autoimmune disease, tics, etc. And I forget to mention that it is not an ordinary anxiety. My son actually slept in a walking closet for 3 months. Would you sign it up? Where is the accountability?

    • How about getting the prescriber to make sure that he/she “knows” all there is to know about a medication before prescribing it? We all know doctors are busy and that there are very many different medications but, surely, it should be in their interest to “know” what they are asking their patient to take? It would entail some extra reading before their first prescription of a new medication I guess but at least all could sleep easy at night knowing that the patient was as safe as possible. Asking the patient to read the info is a secondary requirement surely – they couldn’t ask you to sign something that you’re not sure about unless they had the confidence that their own knowledge was up to scratch!

      • Mary

        So they read the labels of the drugs or even the articles in the best journals and they mention nothing about this. And if someone like you says all this stuff they are reading is ghostwritten and junk you are ignored and even if I do so I’m ignored – although there can be an occasional slip when some higher up reveals that they accept what is being said


        • By saying that I feel a every doctor should “know” all there is to know about a drug before prescribing it , I meant reading ALL that is written – not simply reading the positive articles found in leaflets or journals. Just sticking to the ‘perceived positives’ gives an extremely blinkered view of matters. Every doctor must, by now, be aware of the ‘negatives’ and should make it their duty to ensure that their knowledge of the negative reports is as robust as their knowledge of the positives.

  9. My son suffered terribly on this medication from insomnia and anxiety. We are forever scarred.

  10. Thank you so much for giving the amazing and determined Laura Marotta a platform to share her story, which is so similar to so many of our horrendous experiences with Montelukast. It helped move along the process that led to the much need black box warning. I pray that this warning gives enough doctors and parents pause. Montelukast should NEVER be dispensed to children for seasonal allergies. The benefits do not outweigh the risks.

  11. Thank you, Laura, for your educated and detailed explaination. It’s so sad that all who have suffered will really know never know via trials due to Merck abs the FDA’s flaws. I wish I had known 21 years ago! I cannot even imagine how different my life would/could have been without the Toxin in my body.
    Thank you for your continued advocacy!

  12. My daughter suffered great sadness, anxiety, depression, and insomnia and to date the anxiety and insomnia has not go e away.. I feel so hopeless for not being able to make her feel better, when she does, it comes right back

  13. They should make a button that represent many medicines with the following message:

    The benefits drop and the RXISKS increase further.

    There are no excuses for experienced clinicians having lack of information.
    Surely, clinically, day in/day out, they already witness the harms that many medicines/procedures induce. To think that Valium is still out on the market and having no ‘black box’ warning, is a crime in itself. CB

  14. What is aggravated involuntary manslaughter?
    ‘If, in addition, the conduct of the defendant was so gross, wanton and culpable as to show a reckless disregard for human life, he shall be guilty of aggravated involuntary manslaughter, a felony punishable by a term of imprisonment of not less than one nor more than 20 years, one year of which shall be a mandatory …

    Maybe they could be collectively named as ‘The Dominics’? with ref to the mass killing of people in the care homes and communities of UK. by the british government and their ‘advisers’ – led by a would be machiavelian dominic cummings – who seems to have a weird hold over the P.M. and who has traipsed around from London and all over Durham possibly eaving a trail of viruses – when knowingly infected by Covid 19 – and defended by the cabal of what could otherwise be labelled sociopaths. Hopefully the public will get him out but it will take a miricle to get the pharma cabal who share the same contempt for the public on trial and in lockedin. If there ever comes a time of reckoning for any of them the lesser mortals will claim ‘only doing what we were told’ – ‘only following the guidelines’.

  15. Chewin’ the fat

    Wendy Burn

    When I took over from @WesselyS he advised me never to run a major IT project or to invade Russia. Had no choice over the IT project but to be on the safe side haven’t invaded anywhere.

    Simon Wessely

    There’s still time Wendy. I can point you in the right direction

    Drivin’ up the A329..

    That same media ceremoniously back-up SW

    So if you want to talk about drugs that kill people; better not to go anywhere near WB or SW

    ‘haven’t invaded anywhere’ …

  16. IMAGINE ……………………
    This was a song John Lennon wrote for world peace.
    For some reason it entered my consciousness, this morning.
    I was thinking how things would dramatically change and of course be very different, if all clinicians collaborated together for just one day.
    Imagine if every well informed/intentioned clinician, were to challenge Big Pharma so that necessary beneficial changes could be made.
    A passive gesture, to try and get the message across to Big Pharma, as a sign of making them honest, would be for all clinicians worldwide, not to sign a script pad for dubious medicines, for just one day.
    Just like many who protest down the streets towards parliament, for better changes involving: rights, freedom of speech, wages, work conditions, against racism, for peace, to end war, psychological reasons for the sake of their nation etc………
    Imagine if all clinicians put their script pad in the draw, for just one day !
    The script pad would only be used for patients who require medicines for life threating conditions.
    This POWERFUL passive gesture would be a ploy used by clinicians to fight for safety of our medicines.
    Please visualize this:
    This world would be a better place if we all collectively IMAGINED a drug industry that focused on SAFETY before PROFITS.

  17. There are always going to be BAD APPLES in the Pharmaceutical Industry or any other profession, for that matter.
    The video below explains why we have a major health care crisis around the world.
    This Doctor is a courageous and ethical consultant cardiologist who explains the reasons why we have a complete healthcare system failure.
    Apparently, there is a root of an EPIDEMIC of misinformed clinicians and patients. This stems from biased funding of research. Sadly, this research is likely to be profitable and not beneficial for patients.
    Sadly, Big Pharma engage in criminal activity. He goes on to say that there is very good evidence to show that most of the top ten Pharmaceutical Industries have engaged in corporate crime.
    Between 2009-2014, the combined cost of fraud from most of the top ten pharmaceutical companies is close to 14 Billion dollars. This is for:
    1. Illegal marketing of drugs
    2. Hiding data on harms
    3 Misrepresenting Research Results
    The Doctor explains that we have an industry that is OUT OF CONTROL!


    Does this stem from academia ‘brainwashing’ clinicians not to be CRITICAL thinkers?
    Thank you, for highlighting the fact that there needs to be a revolution where there can be more TRANSPARENCY in the system and there needs to be removal of commercial conflicts of interest from guideline boards.
    Drs need to have an honest discussion with patients about the many medicines they prescribe so patients know that many are not going to benefit an individual. Drs need to EDUCATE their patients about the SIDE EFFECTS of medicines and need to question what are the ACTUAL BENEFITS for an individual and let the patient then make an informed decision. This is called SHARED DECISION MAKING which is more ETHICAL.
    Globally, we are dealing with an EPIDEMIC of misinformed population which is damaging peoples good health. Is this DEMOCARTIC?
    DELIBERATE WITHDRAWL OF INFORMATION when individuals engage in tactics where they SILENCE WHISTLEBLOWERS who have information about a drug that is perceived as BENEFICIAL which may not be EFFECTIVE or people who want to speak out in academic institutions that are aware of RESEARCH MISCONDUCT and FRAUD going on. This is a big problem in British Institutions and it is not being reported because people are scared.
    There needs to be an ENQUIRY to HELP RESOLVE and REVOLUTIONISE the SYSTEM.
    There are many POWERFUL invested interests that are going to oppose because they profit from an old system that is causing tremendous amount of harm to patients.
    There are many solutions to these problems. Finance has trumped health care at every level of the system (people need to come B4 profits!)

    2. There needs to be an enquiry in the quality and research and how it is funded
    3. Medical Education/Training needs to refrain from being BIASED
    4. General Editors need to stop getting highly paid salaries from drug companies
    5. Medical Journals and their reliance on Pharmaceutical funding
    6. Information that is being relayed between doctors and patients

    FINANCIAL INCENTIVES for prescribed medicines should not be happening.
    There needs to be MEDIA ATTENTION and LIGHT shed on these PROBLEMATIC HEALTH ISSUES because much of the clinical research published in medicine at the moment, cannot be reliably trusted.
    There needs to be this PUBLIC ENQUIRY so that everybody knows what is going on and when people know what is going on they cannot be misled!
    The data needs to be reliable and transparent because if this does not happen patients can not make ethical informed decisions.

    We always have to be grateful and stand in awe for people like: Dr Aseem Malhotra, Dr David Healy, Dr Andrew Wakefield and other courageous clinicians who have gained the respect of the public by highlighting dysfunctions in the healthcare system.
    They have lost a lot but gained so much from people like us who have been so adversely impacted by medicines. They have been an invaluable source of education and have made the COMMUNITY aware of the EPIDEMIC CRISIS within the HEALTHCARE SYSTEM.
    They deserve all the HONOUR and RESPECT from us and we owe everything to them for having our backs and not selling us short.
    We have to be truly thankful for these gentlemen getting the information out there and making the most POWERFUL and INFLUENTIAL people aware of a malodorous issue that has been hidden away from the general public for quite a long time.
    They are making a POWERFUL IMPACT on their duty to care about us and PROTECT SCIENTIFIC INTEGRITY.

    So eloquently stated by Dr Aseem MALHOTRA:
    If people in our society are feeling that they are being treated UNJUSTLY or if they are UNHEALTHY or they are ILL or SICK, they are going to be MISERABLE~ that actually effects all of us.
    If we all ACT TOGETHER and help each other then we as individuals FLOURISH and BENEFIT.

    I dedicate this song to all those who help make this universe a better place. ~ YOU SHALL RISE!

    Eventually all these hardships will be conquered by the strength and determination of the people themselves

  18. “The Patronising Disposition of Unaccountable Power”.

    John Read
    @ReadReadj 2hr


    Wilful Blindness

    Marion Brown


    They could know – they should know – they do not want to know, and, it seems, will go to extreme lengths to not know.   Where does this sit ‘in law’?

  19. What I love about RXISK is that many of the people who come here have been impacted in some way or another.
    Passionate, intelligent, outspoken and determined to get your message out there!
    Whatever all you great souls do, just remember that many of you will most likely be walking those powerful corridors of power, in some way/shape or form.
    Do not underestimate the voices of the masses.
    We are most likely doing it now without even knowing where/how our voices reach those in powerful places!
    Keep on spreading the message and remember, for every door that closes, one door will eventually open.
    One of Oprah’s famous quotes, that I will never forget is:
    Rejection leads to direction.
    So when you think/believe that no progress is being made, it comes to all, when we least expect it!
    Keep up the great work because every time you feel deflated, someone has your back!

  20. It’s amazing how Americans put their lives in the hands of a government agency, the FDA, that’s sole purpose is to assist Food & Drug companies to make the largest profits, possible by not causing a vast amount of illness and deaths, within the developing, manufacturing and selling of Foods and Drugs. Why else do you think they allowed pharmaceuticals to advertise drugs, to the consumer, directly, as apposed to the Doctors that are needed to prescribe the drugs to the consumer, in order to purchase them? Because the FDA knew that, with the right afvertising, the consumer would run to their Doctors, telling tgem what they needed to perscribe and it work, like a well oil clocked.
    In fact, when Purdue 1st asked the FDA for approval, to market Oxycotin, as a short term surgy setting, only painkiller, the FDA told them, that if the changed a few words in the labelling in the packet info sheet, the could sell it to consumers as a long term painkiller, omitting some key info on the extremely high risk, in a very short time, of addiction and overdose, creating the whole opiod epidemic, that this country is drowning in.
    It took, CBS 60 minutes, to blow the whistle, on the truth, before the FDA, decided to, finally, try to combat it…way too late, to be at all affective.
    To think the FDA is doing all they can, to protect the consumer, is allowing oneself to fall victim to a false sense of security, by way of, once again, Government lies and cover-ups.
    They are doing all they can to make the government the most amount of money, with least amount of collateral damage. They couldn’t give a rat’s a** about the consumer’s well being.
    So, to think they are going to protect us from any dangerous food or drug from harming us…keep dreaming.
    Be vigilant and research and educate yourself about, any drug, you or a loved one is perscribed, because if you don’t look out for you, nobody else will.

  21. I’m looking for descriptions of how people successfully withdrew from Montelukast. An adult family member is trying to do so and her doctors have no experience with this.

Leave a Reply to susanne