Beware of generic Candesartan… A Chronicles of the Heart supplement.

Candesartan Cilextil is prescribed specifically for heart failure and hypertension. I’d been taking a generic version of this drug for about a year when, suddenly, a fortnight ago, my local pharmacy switched brands. And I found myself having to double the dose to get even close to the effect of the previous brand.

The original tablets were from Takeda UK Ltd. The defective ones from Mylan, in Potters Bar. Not only were the tablets half the size of the Takeda ones, they were quite clearly half the strength too, if not less, despite the strength marked on the box being the same.

This is unacceptable and could have put my life at risk had a been the sort of patient who ignored such things – there are more of them than you might think. But I’m not, I know exactly the response I should get from all my drugs and, in this instance, I didn’t get it.

Now the problem with the generic drug market is that anyone can apply for a licence – and get it. Such licences are subject to inspection, but because of the sheer number of companies jumping on the generic drug supply bandwagon in this country, inspection is retrospective, if it happens at all.

The Medicines and Healthcare products Regulatory Agency (MHRA), is the regulatory body, and I should report this matter to them (so, indeed, should my GP, who should have asked me for the distributor’s name and the lot number, but he couldn’t give a toss either, ditto the pharmacy), but I know from past experience that they simply couldn’t give a shit. Their attitude, for public consumption, at least, is that all generic drugs are perfect, when any user of these things in bulk, like me, with 15 of the buggers to take every day, knows that quality can, and does, vary wildly. And often dangerously.

A classic example of how bad these drugs can be is generic Salbutamol inhalers (Ventolin), which are, frankly, useless (so much so that in hospital spirometry units they use branded Ventolin as the gold standard or, at least, did last time I was there). Luckily, my local pharmacy dispenses Ventolin too. Generic Salbutamol nebules are not a problem due to the very much greater dose, but in my experience are less effective than the branded version.

Another example is generic Naproxen (a NSAID). One tablet of bought-in, US-made, Naproxen, gives me the same result as two tablets of the UK generic drug.

My advice, given that the trade in generic drugs is effectively unregulated – a fact that was the subject of a journalistic investigation not too long ago, in the Guardian I think – is to treat any change in your response to a drug as a defect in the drug, not you, and get it changed without delay. If you enjoy an exercise in frustration, and being told you don’t know what you’re talking about, then feel free to also report it to the MHRA. Good luck with that!

But back to Candesartan, and the first thing that rang alarm bells was the tiny size of the Mylan tablets, less than half the size of the Takeda tabs. OK, so the difference could have been that they used less of the normal bulking agents, often used to make tablets a manageable size when the amount of drug is tiny (4mg in this case). Or, as it turned out, they could actually contain half, or less than half, of the amount of drug that they should.

I did actually consider, briefly, whether it was possible I had dramatically deteriorated in the 24 hours between the last of the Takeda drug and the first of the Mylan, but dismissed the idea as nonsense. I am deteriorating, but to do so, so dramatically, in such a short space of time is, I believe, impossible.

I might be wrong, of course, and in serious trouble, but as my cardiologist, Dr. Nick Newall, at Arrowe Park Hospital has absented himself and the hospital clearly has no interest in setting me up with another cardiologist, I stand by my conclusion that the drug is seriously under the declared strength.

So if you’re taking Candesartan from Mylan, and you feel a lot worse, don’t just assume you are worse, tell your GP – s/he might be more inclined to report the matter than mine – and should prescribe something better.

Feel free to take a copy of this post with you, should you need to.

PS   I suppose it’s possible that the Takeda tablets contained double the amount of the drug, in much the same way as there really might be Lunarians on the moon!

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23 thoughts on “Beware of generic Candesartan… A Chronicles of the Heart supplement.

  1. WOW Ron!! I stopped going to one particular pharmacy, because when I questioned him on tabs that were different to my usual and they didnt suit me, I also know what I take and difference in them! He said they were the same but, generic!? BUT I insisted, were no good to me me, he just shrugged his shoulders and turned his back on me! My GP was the same when I questioned him about it……!!!??? (all in my mind)!? As you said Ron, some people dont check or understand their meds……OR….dare to question them!.
    Your rants, keep me sane, 🙂 Thanks again Ron, ..and GOOD LUCK x

    • Thing is, I’d sure most doctors know generic drugs are often crap, but they’re no longer allowed to prescribe branded drugs except where those drugs are still under patent, and there are no generics. Of course, they should speak out, but they won’t.

      Once the patents expire, all bets are off.

      And most pharmacists are as paranoid as publicans, and take any complaint personally. In the pub it’s just means an argument – with drugs, you could die. If I’d died taking the weak Candesartan, they’d have just recorded a low level and decided I wasn’t taking enough – no-one would have bothered to check the meds.

      Hound your GP – pretty much every type of drug has so many variants that there’s almost certainly on that’ll suit you. Losartan, for example, suits me better than Candesartan did, but the effect wears off faster. I’ll give it a few more days, to see if there’s a cumulative effect and, if not, I’ll switch to 25mg twice a day.

  2. Hi Ron, i had a similar experience with lanzoprazole. change of brands ,didnt work, bad indigestion., doc doubled the strength until such time as they got the old brand back in. apparently some sort of licence problem for TIVA.i notice some of TIVAs drugs are getting back on the shelves now so i aim to ask the chemist next time im near there (or ring) if they have tiva brand lanzoprazole. in now. 30mg of the new brand is fine for most of the day but this past few days have noticed that by teatime im getting a dull achy indigestion again.which food isnt taking off. its too late to take any gaviscon as i already take 4 x 20mls (max dose) before bed for reflux. symptoms of that are fine right now thank god,

    • A few years ago I had problems with Omeprazole causing violet diarrhoea. I checked, and the troublesome brands contained detergents. I complained to the MHRA – it’s all on my blog if you search for Omeprazole – and after a couple of weeks back and forth, they effectively said all they cared about was that the actual drug was present in the quantity stated, anything else wasn’t their concern. Which is garbage.

      I know a lot of people who have had bad experiences with generics, but just won’t complain. And they damn well should.

      • sorry got that dosage wrong. Gaviscon Advance is 4 x 5mls. = 20mls at night.
        will be ringing my chemist first thing in the morning after what youve said and asking them if 1, they’ve got the old brand in stock and 2 if the present brand is generic…..Could they still deny it is even it is?? if so how do i find out if it is?or whats in it?any ideas?

        • They can dispense the branded version if they wish, as my guy does with Ventolin, but profit margins are lower so there’s little incentive. What they have will almost certainly be generic.

          Generic drugs generally have the name of someone you’ve never heard of – I could set up in business selling any damn drug at all – all I have to do is apply for a licence, which they’ll take years to get round to checking on. In the meantime I could wreak havoc selling sweeteners as heart medication, and no-one would know until the deaths started to mount up, and even then, it could take years before anyone thinks to check the drug is genuine, if it ever does happen – it’ll just be blamed and taken off the market. The regulation of generic drugs borders on criminal negligence.

          Branded drugs, though, will have the name of one of the major pharmaceutical companies – Astra-Zeneca, Smith-Kline-Beecham, or Pfizer, for example.

  3. I also noticed the difference in Lanzoprazole tabs and many others, by the way I felt, cos I know which meds to take and the way my body reacts. Thanks to you Ron I know its not just me! I tried different pharmacys and eventually went to Boots, who, were good first of all, because they (as I soon found out) had all my branded drugs.but, after 4th monthly visit, they only had Generic meds.. they were not used to the meds I was using, only the normal meds that doctors give out, willy nilly, to people that are not dying!!!
    Statins are banned in USA….why not here?
    Just checked a few of my meds, Lisiniprol Teva..OMG…just gone through names and checked some of them…..worst one being (I think) is,Consillent Health, 5th FLOOR, MERCER STREET LOWER, DUBLIN 2, IRELAND!!!!!! Thought I was knowlegable about what I take, my Epipens are good, Asprin…? n(didnt think could be generic)
    Pravastatin…nnnooooo good….Seretide.!!!??? I know is not like my normal inhaler..refuse to use it…(sometimes I have to) and so many other meds…….Most of them (generic) are from Hertfordshire and surrounding area….Im glad to know my body and not taking precribed tabs which make me feel iller!!! (no such word) as my daughter said 🙂 At one time I was taking Simvastatin, Atorvastatin,Lipdor , lisiniprol..and Bisoprolotol, when I first found out about my Heart disease RHA, ….because I felt so ill……luckily, I argued with GP,, who said, ring up H|eart Man then!!!.. people were saying , Stop self medicating……oohhh I could go on and on and on…..Like you I have ME/CFS and many other disabilities, but, Im so lucky to have come across you Ron, I know its THEM..not ME…Thank you for your help and please keep fighting….Im out of breath now…Phew :)..wish I were Literate, hope you understand my words…Cheers …….:Darcy…:)

    • Hi Darcy,

      Statins are still permitted in the US, though it’s true some are banned. Personally, they should be universally banned, because of one simple question – where does the cholesterol go? It can’t just vanish, that’s impossible, so like much else, it gets filtered from the blood by the liver and kidneys, and damages both in the process – everyone on statins is supposed to have regular liver and kidney function tests, but I’m willing to bet that nobody does.

      Statins can also cause rhabdomyolysis, an extremely painful and disabling condition in which the body consumes its own muscle tissue – as they did the one time I tried them. Took them for 4 days, was in agony. Never again, and I’m in a very high risk group – I’ll take my chances!

      Statins are snake-oil for the 21st century – hardly a month goes by without another use being claimed for them, and frankly, I don’t believe it – I think it’s just a way to extend the patent by a few years without any concern for the risks to patients. It’s fair to say most people have no apparent problems with statins, but who knows what problems they’re storing up for, say, 20-30 years in the future? No-one, that’s who.

      Aspirin has been generic for generations if, indeed, it was ever patented, as it grew out of the herbal version, white willow bark, which contains salicylic acid. Aspirin is simply a synthetic version, acetysalicylic acid.

      If inhalers, and other products, have the brand name on them – Seretide, Ventolin, Serevent, etc, then they’re not generic. Generic drugs are always labelled with their chemical name – Salbutamol (Ventolin), Omeprazole (Losec), for example.

      Tell me you weren’t taking all those statins at the same time!

      The name and address on your drugs doesn’t matter much – there’s no telling where they were made – they just get bought in and repackaged.

      I suspect, with Boots, if you were taking something out of the ordinary, then what happened was you used up their branded stock, and they had to generics in then – I don’t think it’s any more sinister than that.

      Ain’t life grand?!

      Ron.

    • Other than complain to our GPs, nothing. The big problem there is that GPs simply label you as awkward if you report problems with drugs,** instead of getting off their lazy, overpaid arses and sending in an adverse reaction form.

      **There are two classes of drug I won’t take, statins and Cox-2 inhibitors, because both cause extreme muscle pain, and one specific drug, Distaclor MR, which has put me in hospital twice with chest pain. But, according to my GP, I’m always complaining!

      I’ll be complaining more tomorrow, as the new heart drug, Losartan, is a disaster – it simply makes every major problem I already have worse. No way I’m putting up with that. And I’m not at all impressed with the sub-literate patient information leaflet – urinary track infection? Too less sugar in the blood? The list goes on, and it also warns about using them with heart valve problems – my major bloody problem!!!

      Pissed off doesn’t begin to describe how I feel right now!

      Ron.

  4. Hey Ron, YES I did take them all for 2 days but was so ill ended up in hospital AGAIN, and told to just take simvastatin!?!?!? Ive not been right since, and like you, question everything (well nearly).
    Had already complained to PALS about GP, he gave answer but, it didnt make things any better, although he was nice to me on my first visit after complaint!
    I get in a bit of a panic when I write down all this stuff, I dont know how your living with it all!!!!
    I bet your pissed off…just read letters from hospital and cardiologist!!! AAARRRRGGGGGGG……Best thing, I think Ron is to go to another hospital (by ambulance) stay in for couple of days, and tell them what you think and have SOME tests done, otherwise you will unfortunately die! Good Luck ..
    Darcy.

    • That’s kinda my argument, Darcy – all the tests in the world won’t stop me dying. They won’t change things one iota – there is no cure for heart failure or a calcified aortic valve,** so what’s the point of the tests? The medication I need has the potential to make things better while I’m still here – don’t need tests for that either.

      **OK, there’s surgery to replace the valve but given what else is wrong with me I doubt I’d even be considered, or survive it if I was. It certainly hasn’t even been mentioned.

      If you have any muscle pain, you really need to talk to your GP about stopping statins – they can cause rhabdomyolysis, a condition which causes breakdown of the muscles.

      • Thanks for reply Ron I dont take statins anymore, as you know with ME/CFS we have enough muscle pain anyway, I stopped taking them months ago…. Back to you Ron…Another hospital with different cardiologists could come up with different answers and HOPEFULLY listen to your concerns and be more understanding about the things you know about your conditions! Wont do you any harm! 🙂 Who knows, you may have done something to help others ,like you, going to see the disgusting so called heart specialist!!!!!!!!!

        • Actually, Darcy, the chances of being able to get to another hospital – which means Liverpool – are far less than being able to get to APH. And my records would follow me to the other hospital, along with whatever this clown has written, so I might as well stick with APH.

        • Doubtful – based on past experience, if I ask for Digoxin he’ll prescribe something different – he’s got this odd idea that he knows best! 😉

            • I know GPs know about a load of stuff, but by their very nature, they can’t get into the minutiae of more than a couple of conditions – they just don’t have time. Whereas I do have time, and I defer to nobody, GP or consultant, in my knowledge of what ails me – I can read medical journals and research papers just as well as they can – OK, I might have to look up some more specialist terms, but I suspect many GPs do too. And consultants – after all, it’s many years since medical school when they HAD to know them.

              This should work both to my advantage and that of the doctor – I know what he or she is talking about, so no time wasted explaining. I also have a good idea – because I’ve eliminated those that might make me ill or try to kill me – what drugs I need.

              Never works out that way – doctor knows best still rules as far as most GPs and consultants are concerned!

              And Newall lost interest when I refused left ventricular catheterisation because it carries a 24% risk of stroke, based on this document http://www.ncbi.nlm.nih.gov/pubmed/15215790

              And this one, which I’ve found since, shows that it’s not necessary anyway
              http://www.icr-heart.com/journal/content/2004/may/pdfs/Chambers_2186.pdf

  5. Ron, go to Liverpool Hospital, so what if your notes follow you, I bet there will be a heart specialist who would look forward to meeting you! because they wouldnt dare put you with some one who doesnt have a clue! Youd most probably meet the top cardiologist, who, Im sure would welcome you and your knowledge. You could go by ambulance, I know its hard and long, but, give it a try, dont worry that your complaints and emails will put other cardiologists off, just because youve had bad experience with HIM!!!!!!!
    Please try it 🙂 x

  6. Ron, go to Liverpool Hospital, the notes and complaints you have made will most probably stir quite a bit of good interest in a few GOOD Cardiologist, and they will put you in touch with the best, who would most probably look forward to meeting you and listening to someone who has at least tried to understand his illness, and has great knowledge about your illnessess (is that such a word?) They (Doctors) know who is good or bad at their jobs!!!!??!!!
    I know journey is hard by ambulance, but, prepare yourself and im sure you will get a great responce from another Hospital.
    Dont wait around for your GP or HIM at your local Hospital……You know so much, go and speak to another Cardiologist…Please.
    Darcy.

    • The guy at Liverpool is the same guy who, after my angiography, dressed the hole in my femoral artery with half a Cornish pasty suck in his mouth. Deeply unimpressed then, haven’t seen any reason to change my mind.

      That’s also the guy who, during my angiography, couldn’t find one of my coronary arteries, so he asked the tech to prepare a load of contrast medium so he could flood my aorta, in the hope it’d find its way into the missing artery.

      Then he suddenly found it, and the tech guy was left holding a huge syringe, about which they then had a row over who was going to pay for it. And all this time I’m lying there with a tube in my heart and a hole in my thigh!

      And guess who referrals from here go to… Yep, him.

  7. OH NO!!!!!! Sorry Ron just trying to think of things to help you! Is there only one cardiologist at each hospital? for gods sake…..Are they just small hospitals? Here we have our local hospitals, but we have big main hospitals, Where’s the nearest BIG MAIN Hospital? because they have more than one cardiologist at main rather than local hospitals.
    As I said Ron im not very good with words and I hope its not come across as moaning at you, because thats the last thing you need! and the last thing I meant.
    Hope you have a good day.
    Darcy 😦 🙂

    • Hi Darcy,

      Don’t worry! 😉

      Trouble is the senior cardiologist at Liverpool also works at APH, so referrals from here to Liverpool naturally go to him.

      No, they’re both big hospitals, with multiple cardiologists, but I have no control over who I’m referred to, not least because I don’t know who they are.

      The main problem with Liverpool, though, is the almost £40 taxi fare (return). If I’m broke I can use my chair to get to APH, and I might just do that.

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