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Prescribing Advice for GPs

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Zafirlukast discontinued

The manufacturer of zafirlukast (Accolate®) has discontinued this product with effect from the end of March 2018. No further supplies are being made and it is predicted that minimal supplies will be available within the supply chain.

Commercial reasons are cited for this decision and it is stressed that there were no safety concerns with this medicine. Zafirlukast is a leukotriene receptor antagonist and as such the closest available alternative is montelukast.

Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow a review and arrangements made to identify a suitable alternative.

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52 Comments to “Zafirlukast discontinued”

  1. I'm in the U.S. but am also worried about zafirlukast being discontinued. I recall how upset I was when Accolate disappeared and no one had an answer. I hope they keep making zafirlukast, since my asthma is bad enough WITH it, along with inhaled corticosteroid and albuterol. Very few health professionals (and people in general) have real sympathy for or understanding of how debilitating asthma can be! I'm certain that this action of removing a drug that works is so they can sell patients and doctors on whatever the newest, expensive drug is, whether it works or not, or has horrible side effects, as long as they make money.

    Comment by Susan — March 19, 2021 #

    1. @Susan,

      Here in the UK we only ever had access to the branded version of zafirlukast (Accolate). It seems in the US an agreement was signed to allow generic manufacturers to make zafirlukast, but that never seems to happen here in the UK and I cannot locate confirmation that the deal continues. It seems if you are able to access zafirlukast then supply must be continuing locally via a generic manufacturer. In the UK, it seems that there are no licensed versions of zafirlukast from any supplier.

      Comment by Matthew Robinson — March 21, 2021 #

  2. I have acute asthmatic bronchitis and I have been on zafirlukast for 9+ years.
    I haven't had any side effects from taking this medication whatsoever.
    I'm very concerned that they have discontinued this medication. I was on montelukast in the beginning of my illness and it does not work for me.
    I've been taking 2 x 20mg of zafirlukast at night with Zyrtec. I've been told that the montelukast is my only option. How and why is this happening in the middle of a global Covid-19 pandemic that is attacking people's respiratory systems? This puts a big stress on me and it also triggers my asthma just researching this. I also take inhalers Advair and Pro Air but these along don't do well without my Zafirlukast. I have fallen asleep a few times without my Zafirlukast and Zyrtec and I've payed dearly for it during the night and into the next day. I can't believe that a medication that helps thousands if not millions of people has been discontinued.
    I don't mean to sound harsh but at the risk of not being able to breathe: Maybe if the companies owner had these breathing problems that we all suffer from hopefully they would reconsider making this medication again. It's very scary not being able to breathe and looking at yourself in the mirror and thinking of calling 911 and feeling like you just took your last breath because they aren't going to get there in time. Please RETHINK this discussion, lots of people are counting on it. Thank you, from "Trying to Breathe" in Florida.

    Comment by Lisa — December 28, 2020 #

    1. @Lisa,

      Here in the UK, zafirlukast has not been available since March 2018. It seems in America there was an agreement with Par Pharmaceutical for supply and distribution, and zafirlukast is still listed on their product portfolio. One avenue to check would be to contact Par Pharmaceutical as

      Interestingly at the time of the announcement of that agreement in 2010, US sales of zafirlukast were around $50 million per year. That's a small piece of AstraZeneca's global respiratory business $4,099 million per year in 2010 (from published Annual Reports). And respiratory is the third largest clinical area where they sell products. Sadly, I suspect the product just wasn't a priority for the manufacturer. Usually another company will buy the product but seemingly no other companies saw any benefit in doing that either leaving us without this drug as an option.

      Comment by Matthew Robinson — December 29, 2020 #

  3. I take Montelukast which I have been told is now a black box drug causing mental issues. What is going on, there is now no alternative, per my specialist. I have been taking this for over 10 years, with no issues, and now they say just stay off of it in a middle of a pandemic with respiratory exacerbation. What is happening? Is there really no substitute? Already starting to use rescue inhaler more, have to be very careful and monitor myself closely.

    Comment by Eileen Sanders — October 9, 2020 #

    1. @Eileen,

      'Black box' warnings are issued by the FDA and apply in the US market. This issue is not new, it was issued in April and even then it was an update. You should see that the advice is to continue the medication and stop it only if you experience mental health side effects. As you have been taking it for 10 years without problems I really cannot understand why it has been stopped, especially as when you've stopped it your asthma control has worsened. I'd suggest you speak with your doctor about restarting it if they cannot offer you an alternative (like an inhaled corticosteroid for example).

      Comment by Matthew Robinson — October 9, 2020 #

  4. How can a GP prescribe or druggest have Zafirlukast on the shelf when it was taken off production two years ago? I thought all drugs were disposed of after one year on the shelf. Do the druggest just tell us they have a shelf life so that we will have to order a new prescription?

    Please send me answers to my questions. I am devestated that my trusted (?) family GP would start me on something that is no longer produced.

    Comment by Margaret D'Aquin — July 6, 2020 #

    1. @Margaret D’Aquin,

      Medicines have variable self lives but it's not uncommon for it to be several years, not just one.

      This site is also aimed at healthcare professionals in Britain, the information on here may not be accurate for other countries and healthcare systems, need it seems the zafirlukast is still available in other countries around the world.

      Comment by Matthew Robinson — July 7, 2020 #

  5. I talked to my pharmacist and he says that generic Accolate is available -- Zafirlukast. I would think that would be better than none at all and I just now requested it. Singulair seems to be NOT for me.

    Comment by Leti — May 7, 2020 #

    1. @Leti,

      It seems generics are licensed in North America, but I cannot find any product availability for Europe. Also, several of the outlets I can access list this drug but on closer inspection report it is not currently available.

      Comment by Matthew Robinson — May 7, 2020 #

  6. I have now been taking Accolate for over 20 years with controlled asthma. I have been able to get the drug until this week in the middle of the Covid crisis. I am very upset that I will need to change my asthma medication in the middle of a respiratory virus pandemic. I am worried and I am scared.

    Comment by Sherri Andrews — April 9, 2020 #

    1. @Sherri Andrews,

      I can understand your concerns but I also think you have been incredibly lucky to obtain a medicine for 2 years after the manufacturer discontinued it. As the post above says, montelukast is the closest equivalent. It might be worth making a phone call to your GP and asking for a prescription for that to try.

      Comment by Matthew Robinson — April 9, 2020 #

    2. Funny. Because I have been on Montelukast and now they are saying there is a shortage of that and I have to use zafirlukast

      Comment by Lucy VanSickle — April 11, 2020 #

      1. @Lucy VanSickle,

        In the UK montelukast is made by at least 4 different companies so any supply issues are likely be short term blips. Zafirlukast was only manufactured by one company who announced they were stopping manufacture and supply here 2 years ago now.

        Comment by Matthew Robinson — April 12, 2020 #

  7. I have suffered with asthma and COPD for 25 years and zafirlukast gave me real relief these past 12 years but montelukast has not worked at all. I'm suffering badly and now can't walk or do anything without being breathless. I use my inhalers all the time. My GP prescribed zafirlukast yesterday again so she was not aware this was discontinued. Why have they discontinued this drug as montelukast doesn’t work.

    Comment by Joanne Riley — August 7, 2019 #

    1. @Joanne Riley,

      It was discontinued for commercial reasons, that basically means it was not making enough money to justify continue production.

      Comment by Matthew Robinson — August 7, 2019 #

    2. I have the same problem. When they changed out this medication to Montelukast I have been more sick, and have had pneumonia twice this year. My lungs are always full of Rails and breathing and coughing is ridiculous. I can't exercise without becoming very breathless and blood oxygen levels go so low I feel out of sorts until I take additional medication "puffers". They don't care about our health these Pharmaceutical companies, all they want is more money and not one pill out there comes without side effects. Accolate was just that, a drug that prevented pneumonia strains and when they discovered this they removed it from the market saying it can cause death. I have two boxes of Accolate that were prescribed just before they took it off the market and I took that stuff for more than 3 years and it made my lungs really healthy. Now you see why Pharmaceuticals don't care about our heath, it's more about the money and how much they can make and Doctors lie and say that a certain drug doesn't cause cancer or what ever side effect you read about. Let's be honest here, why would someone want to take a drug when some of the side effects are more serious down the road than if a person were not to take the drug at all. It's just like Chemotherapy. It causes more damage and speeds up the time it takes to die from cancer if a person has been diagnosed. We should take the pharmaceutical companies to the Highest courts in the land and have their licenses revoked for not selling cures instead of prophylactic's that cause so many other diseases. This has been a well known fact for many years yet the Governments allow Pharmaceuticals to produce junk to put into our bodies. I say go natural if it helps more than the Pharmaceuticals.

      In addition to the above, Pharmaceuticals don’t make a difference and if they do its so slight just enough to get you to keep taking their drugs. But later down the road you wonder why you have certain ailments and often times they are life threatening. I say Clean up your act to the Pharmaceutical company’s because after a while insurance companies are going to stop paying you exorbitant amounts of money to keep you afloat. The Billions of dollars you make each year says it all you couldn't care less about our health you only care about the ever living dollar.

      Comment by Patrick — December 2, 2019 #

      1. @Patrick,

        I'm not sure what the situation was like around the world but zafirlukast never really sold very well here in the UK. I'm more inclined to believe it was discontinued due to lack of sales if the UK situation was matched elsewhere.

        It is an unfortunate fact that the capitalist economic system is the most effective at encouraging development of new medicines. That results in individuals and companies needing to recoup their investment via sales. I'm not aware of any other economic system being more effective at creating new medicines.

        Comment by Matthew Robinson — December 2, 2019 #

        1. I appreciate your comment but it is to my knowledge that Zafirlukast is still available in the UK, I can order it from the USA and it is still available in the USA. It is not available in Canada and I am almost certain it is because it was a good drug and actually put a stop to pneumonias, hospital stays, and death; frightening moments.
          The Pharmaceutical companies care nothing more than what sells and what doesn't and is it good or not. Just last year I called and tried to order Zafirlukast and it was a guy in the states and he said we can't sell it to Canada. Now you tell me why this is so. Because they want to keep us as sick as possible in hopes that we will die and decrease the surface population. I am sick of taking pills that only have a placebo affect. Making me sicker in the end because they cause another problem for my body to deal with it and truthfully a persons immune system becomes weakened with all the mess that is out there. I wish I was the leader of the country for I would put a stop to all of this I would say you either produce drugs that treat the root cause or I revoke your license to sell. Then Pharmaceutical companies won't be able to sell band-aids for people on their death bed.

          Comment by Patrick — September 27, 2020 #

          1. @Patrick,

            I live and work in the UK and I can categorically tell you that zafirlukast is not available here.

            This site is intended to be an information resource to UK healthcare professionals so the information on here is only pertinent to the UK market, I cannot comment on, nor confirm what is happening in other health economies.

            Comment by Matthew Robinson — September 28, 2020 #

  8. I just found out that my GP swapped my medicine zafirlukast 20mg for the montelukast 10mg, I didn't realise this until I became short of breath and for the last 2 months I've been on my inhaler (salbutamol) every morning, evening and sometimes half way through the day. So, this Monday I checked the package and realised the medicine I've been getting for the past 6 months is different - I honestly thought it was just a different brand therefore different package/box and that the main ingredient was the same. I couldn't have been more wrong! What shocks me to my core is the fact that they have changed my medication without warning or consulting me. Is there any other medication similar to zafirlukast as montelukast doesn't agree with me reason why I was put on zafirlukast back in 2007.
    Thank you.

    Comment by Elizabete Ventura — April 18, 2019 #

    1. @Elizabete,

      If your medication changed 6 months ago and you've only noticed symptoms in the last 2 months I would not necessarily link this to the change in medication. Also, zafirlukast was to be taken twice daily and montelukast is only taken once daily. You need to check you are taking the correct dose, especially if you thought they were the same thing until recently.

      In answer to your question though, there are only two drugs in this class of medicines (leukotriene receptor antagonists) that have been marketed in the UK. When zafirlukast was discontinued that dropped to one option; and that's montelukast.

      Comment by Matthew Robinson — April 18, 2019 #

  9. Accolate is a hands down winner. Montelukast is not even close in helping my breathing. I too was a long term user with not one severe asthma attack. Absolutely disgusting that with all the money we (Canada) have in our health care system we don’t have enough to insist that the best drug be prescribed and let the other one go away. Haven't been this short of breath for years.

    Comment by Lawrence Parsons — March 19, 2019 #

    1. Still waiting for a medication that performs anywhere close to Accolate! This is serious! I have been on the recommended alternate and perform at less than 50% along with all the associated discomfort. I had saved 2 pills both outdated and out of desperation took one today one today only to find that within 2 to 3 hours enjoyed the joy of easy breathing. I pay a considerable amount of money (Can$136.00) for the non-performing alternate. Please reconsider putting you well performing product back on the market. I am in your Fasenra study and while it has helped the difference is in no way comparable to the original medication. I know it is a different type of treatment but it is not comparable in successful treatment. Lawrence Parsons

      Comment by Lawrence Parsons — September 18, 2019 #

  10. My GP, chemists and consultant were totally unaware until I researched it and found out it was discontinued. I'm totally disgusted that this can happen with no other alternative for us than to go back on a drug that previously caused bad side effects. I also had to go back on the montelukast and am still getting severe headaches although my asthma is a little better on it rather than on nothing like when I ran out of the zafirlukast. But definitely not as good as when on the zafirlukast, how is it allowed that they can just decide to suddenly discontinue a drug that keeps so many asthmatics stable at the drop of a hat because it doesn't make them enough money? It's unethical and dangerous.

    Comment by Kat — November 13, 2018 #

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