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Barbadians Should Be Vigilant When Filling Prescription Drugs

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120px-rx_symbol.pngIn the Nation newspaper, 4th December 2007, there was a brief article on page 3 which advised Barbadians that the marketing and sale of the drug ‘Prexige – cox 2 inhibitor’ has been suspended by the Ministry of Health. The notification coincided with a note that we received from a member of the BU family – thanks for the literature as well!

On the surface, it seemed a harmless announcement but after careful reading of the ‘literature’ we became alarmed! We learned that the drug ‘Prexige’ was recalled in Australia since August 2007.

We quote from a media release published on Novartis website:

Novartis Pharmaceuticals Australia has complied with the decision of the TGA to withdraw all doses of Prexige, a Cox-2 inhibitor for the treatment of osteoarthritis and acute pain, with immediate effect.

This action has been taken after a number of cases of serious liver side effects were reported in Australian patients taking Prexige, including two deaths and two liver transplants. Serious liver side effects have been reported rarely for all Cox-2 inhibitors and traditional NSAIDs.

Novartis estimates that approximately 60,000 patients have used Prexige in Australia, and the majority of these have been prescribed Prexige 200 mg for the management of osteoarthritis. Prexige was first made available to patients in Australia in November 2005.

Our sources have confirmed that pharmacies in Barbados received the order to yank ‘Prexige’ on the 25th November 2007. Of concern to Barbadians should be the three other drugs in our pharmacies which should be yanked as well, according to our sources. These drugs are: Celebrex, Mobic and Norflex which have been described as cox 2 inhibitors as well. These drugs are alleged to be causing the same symptoms as ‘Prexige’.

Out of an abundance of caution, we have published this article in the hope that people on the Internet who are knowledgeable about this case can provide leadership for Barbadians. Regrettably, the cryptic note which was published in yesterday’s newspaper is all that Barbadians can expect to hear on this matter.

We are forced to question the role of the Barbados Association of Medical Practitioners (BAMP), our Association of Pharmacists and most of all the Ministry of Health!

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26 responses to “Barbadians Should Be Vigilant When Filling Prescription Drugs”

  1. Georgie Porgie Avatar
    Georgie Porgie

    Why the panic?

    What exactly do you want BAMP and the Pharmacists and the Min Of Health to say?

    I would love to try to explain this to you, but since it is so complex for even medical students and doctors to comprehend, how will it be possible to discuss such technical aspects of pharmaco-chemistry to laymen who can not even reason on more simple matters.

    Pointless!

    You will now get many comments on this topic.LOL

  2. David Avatar
    David

    Georgie what is so difficult to understand that the Pharmacists and the Doctors prescribe drugs which from they own research appear to be suspect.

  3. Georgie Porgie Avatar
    Georgie Porgie

    Pharmacists dont prescribe drugs. They are in my view glorified tablet counters.

    Most doctors have not researched the drugs they prescribe. Most go by what the drug reps tell them about the drugs.

    Most drug reps dont know much about the drugs they detail.

    ALL drugs are suspect- they are all potential poisons. If you take an overdose of say panadol you will destroy your liver and you WILL die.

    The whole issue of the cyclooxygenase (COX) pathway has to be explained to start with. This is not so easy to do. Then you must explain what COX 1 and COX 2 are and the differences.

    Aspirin blocks COX 1 and COX 2 . Most folk have been using Phensic (aspirin) all their life.

    COX 2 drugs were made to prevent the side effects that aspirin and its close relatives does. It aint so simple- thats all.

    Solution dont jump into prescribing or dispensing new drugs. For the public be careful of taking newer drugs.

    Wait till they kill hundreds of Americans etc from abusing them first and then get withdrawn by the FDA before thinking about not using them

  4. David Avatar
    David

    We deliberately referenced that Pharmacist prescribe drugs because we all know that it happens, below the counter. Can we agree that a significant amount of drugs are dispensed without prescription in this country?

    Our query in our article is simple. If Prexige was withdrawn in Australia since August 2007 why has it only been withdrawn in Barbados in November 2007?

  5. Avatar
    Anonymous

    David,

    “If Prexige was withdrawn in Australia since August 2007 why has it only been withdrawn in Barbados in November 2007?”

    ……………………………………………………………………

    Damn! You REALLY are STUPID!

  6. Avatar
    Anonymous

    David,

    Your standards have fallen tremendously.

    Only Australia and Barbados? Please research and report the dates Prexige was withdrawn in EVERY country of the world so that we can make an accurate and informed decision.

    You owe it to your readers!

  7. David Avatar
    David

    Mr. Anonymous we are a country that boast of the best health care in this part of the world. Other countries should be benchmarking to us. To think you are talking about low standards.

  8. Georgie Porgie Avatar
    Georgie Porgie

    Re We deliberately referenced that Pharmacist prescribe drugs because we all know that it happens, below the counter. Can we agree that a significant amount of drugs are dispensed without prescription in this country?

    Ok You are probably correct……but I cant be sure.

    Re Our query in our article is simple. If Prexige was withdrawn in Australia since August 2007 why has it only been withdrawn in Barbados in November 2007?

    Ok your query is relevant.
    I will not call you stupid as another did, and without defending the medical fraternity at home I will offer a few reasons.

    Perhaps in Australia the drug is widely prescribed, but is not widely used in Bim. Consequently the incidence of side effects were not seen in Bim at all as yet. If this is so then our professionals are still proactive by banning the drug a few months after the Australians.

    Perhaps in Australia patients have presented with symptoms, and they have not done so in Bim. After all we can not be sure to what levels the liver enzymes of our populace are induced and thus helping us to prevent liver disease. If this is so then our professionals are still proactive by banning the drug a few months after the Australians.

    I cant be dogmatic because I don’t know what has been seen at home. I do know that it takes a while for drugs approved in the US and elsewhere to get to our shores. I also don’t think that in every case where one country withdraws a drug that we must always follow suit.

    In the USA many good drugs are banned or not available that are available in the UK (and thus Barbados).

    Also in the USA, advertising of drugs is now patient driven. The tv ads say ask your doctor if this might not be right for you? Hence they might be a lot of over prescribing.

    In the USA many drugs that we consider POM (prescription only medicine) are OTC (over the counter). This is more likely to cause abuse.

    Im not sure about Australia.

    I would think too that the cost of COX 2 inhibitors (though available in Bim) is probably so high as to be prohibitive to prescribers and patients. Hence we might have a low incidence or no incidence of side effects.

  9. Bush tea Avatar
    Bush tea

    Interesting info GP,

    What process exist here that could help us to identify persons who may succumb to liver failure through having used any particular drug that may have that side effect?
    I worry that even if we had higher rates of side effects than Australia, we have no well defined system to know this- and to take action.

    As we expose ourselves to so many new drugs and other chemicals it is not clear to me how we analyze the consequences of these poisons.

    I try to avoid them all – and I worry even about such ‘innocent’ things as toothpaste (with floride?!?) soaps etc – not to mention the well known poisons like aspartame…

    Do I need to have your level of knowledge just to protect myself and my family GP?

  10. Georgie Porgie Avatar
    Georgie Porgie

    Bush Tea

    I agree with you that all folk should avoid drugs and foreign substances as much as possible…..including aspartame.

    I must tell you that even with my knowledge that it is difficult today to protect oneself and family if we eat the packaged foods that we use today. This includes the creams and lotions etc that we are also using.

    In fact the skin is a ready site for absorption of drugs especially if the agents are fat soluble.

    When we are ill, we might have to use drugs. That cannot be helped sometimes. Unfortunately all drugs have side effects. Sometimes by adjusting the dose, side effects can be reduced.

    Beware of so called natural products. Though some are definitely useful. Others , like St John’s wort can be absolutely dangerous.

    There is no process per se that exists to identify persons who may succumb to liver failure through having used any particular drug.

    Since the liver processes everything that goes from the stomach, the liver is most liable to disease states as a result of ingestion of inimical substances. But scientist know that differences in folks diet, age, gender and other factors effect the liver’s response to certain substances differently. We don’t know it for everything.

    Now drugs are tested before they come to the market. But the number of persons they are tested upon is quite small relatively. When the drug comes onto the market and larger and larger numbers of folk use the drugs, we get to see side effects that were not previously seen.

    As we learn more about the drugs, we tend to withdraw them from the market. When this happens, there is no need to panic!

  11. Global Voices Online » Barbados: Drug Recall

    […] Barbados Underground is concerned about the recall of a prescription drug, saying: “We are forced to question the role of the Barbados Association of Medical Practitioners, our Association of Pharmacists and most of all the Ministry of Health. Share This […]

  12. Avatar
    Anonymous

    David,

    Your standards fall every time you behave like the vermin at BFP and try to POLITICISE matters which have nothing to do with politics.

    There is nothing wrong with you being a DLP supporter… but you should keep your POLITICAL LOYALTIES out of non-political national health issues such as this one.

  13. Sapidillo Avatar
    Sapidillo

    Maybe I have misconstrued the article. In my opinion, the article is no more than an informational piece to all readers. Concerns such as this are discussed all over the world (small and big countries). I see no need why anyone would attempt to put a political spin on the issue.

    Depending on many factors, all or most drugs can be poisonous to our bodies. A drug may prevent or cure a disease but it could also cause side effects and/or do damage to another part of the body.

    Because a drug affects one person that doesn’t mean it will affect the next — some people can take Aspirin, Penicillin, etc without any signs of being allergic to it, while others can’t.

    Do we know what guidelines the pharmaceutical companies use before a drug is put on or pulled from the market? When a drug is pulled, is it based on the number of complaints, such as deaths, side effects, etc? Is it based on follow-up studies, or is it based on other reasons undisclosed to the general public?

    I’m not sure that because Australia pulled the drug in August, that Barbados should have pulled it the same time.

  14. Linchh Avatar
    Linchh

    David:

    I join the discussion only because I have taken Prexige for a bout of severe osteoarthritis in both of my feet earlier this year. My doctor prescribed it after other non-steroidal anti inflamatory drugs (NSAIDS) failed to give me any sustained relief. At that time I was aware of the adverse gastrointestinal reactions associated with those drugs, as well as the reasons for the recall of Vioxx and Bextra.

    Luckily for me I have blood work done on a regular basis to monitor the effects of other medication that I take, so was able to obtain reasonable assurance that the medication I have taken has had to adverse effects on my liver function.

    I support the position taken by GP (does that stand for General Practitioner), and wonder whether the “sources” that are advising you are suggesting that all NSAIDs should be removed from distribution.

    Incidentally you seemed to have visited the Australian novartis website, but on the generic site http://www.novartis.com the the following statement was posted re the recall of prexige in the United Kingdom and Germany:

    “Liver enzyme changes are a known side effect of all COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs). Available data suggest that Prexige 100 mg once-daily for osteoarthritis is not associated with increased hepatic (or liver) risk compared to other NSAIDs.

    The latest analysis of patients taking the Prexige 100 mg dose showed nine severe hepatic events reported worldwide. This corresponds to a rate of 5.19 events per 100,000 patient-years, which is within the rate expected for NSAIDs. Although a direct comparison cannot be made between spontaneous reports and epidemiological data, a major analysis of epidemiological studies on NSAID-induced liver injury resulting in hospitalization showed an incidence rate of between 3.1 and 23.4 per 100,000 patient-years.”

    I think that you will agree that would be absurd, to deny patients the benefits of NSAIDs and that we should continue to rely on the good judgement of the medical profession on the appropriate means of treating what can be often a crippling condition.

  15. Georgie Porgie Avatar
    Georgie Porgie

    Hi Linchh

    I agree with all that you have said.

    Re and wonder whether the “sources” that are advising you are suggesting that all NSAIDs should be removed from distribution.

    NO SIR! Not at all. NSAIDs are useful. We have been using them for many years now. (Most of us grew up on Phensic for every pain). We just must not ABUSE them. I do agree with you that it would be absurd, to deny patients the benefits of NSAIDs.

    You have correctly pointed out that
    “Liver enzyme changes are a known side effect of all COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs (NSAIDs). Available data suggest that Prexige 100 mg once-daily for osteoarthritis is not associated with increased hepatic (or liver) risk compared to other NSAIDs.

    From here I can see that you are more intelligent and better read than the average patient anywhere.

    I see also that you are taking a low dose of the drug, you are getting regular LFT’s. You are obviously in good hands- as is to be expected from most of our local doctors…… and you most certainly should rely on the good judgement of the medical profession

  16. Linchh Avatar
    Linchh

    GP:

    It cost me quite a bit to put my two eldest children through medical school – one in the UK and the other in the USA – and though they are not in Barbados, I seek their opinion when in doubt about any medical advice that I receive locally.

    I do follow the available information on medical issues that affect me and discuss them with my local doctors. I find them to be quite responsive to my concerns.

  17. Georgie Porgie Avatar
    Georgie Porgie

    Linchh

    Congrats.
    Seems your money was well spent.
    You are being well informed by your children.
    May God bless them richly in thier work.

  18. David Avatar
    David

    We have read all the technical comments which we are sure are above most of us who read the blog. Let us pose our concern in another way.

    Should Barbadians be satisfied that the doctors and the pharmacists are sufficiently in tune with the fine balance which we need to maintain to protect the health of our people.

    Can we assume that if there was negative feedback in Australia about Prexige that similar symptoms should exist in any market where human beings exist?

  19. Bush Tea Avatar
    Bush Tea

    Why you gone and pose that question that way David?

    Why would a Doctor (who makes his money BECAUSE people get sick) be even interested in protecting the health of Barbadians (except of course in the case of their father in GP’s case or similar personal associate). Same goes for a pharmacist.

    If Barbadians were perfectly healthy then these professionals would become beggers.

    …herein lies a fundamental problem.

    EVERYONE now knows that there are a number of common habits that are public health hazzards …. not only smoking etc but sweet drinks, many food additives and even food choices.

    If you were a doctor, would you dedicate yourself to educating your potential customers to avoid having to require your services?

    …GP – you don’t count. You are a special case.

  20. David Avatar
    David

    BT there you go dousing all the aspirations which a member of the BU household has by casting aspersions on that noblest of professions.

  21. Bush Tea Avatar
    Bush Tea

    Those are not aspersions David, just genuine questions in trying to understand the logic of our world.
    Should our national systems not reward the kind of behaviors that we wish to encourage? (..and this is NOT a Bajan thing here- I am speaking globally)

    Should not a teacher be rewarded in proportion to the number of successful graduates he or she produces?

    Should not a doctor be paid in direct proportion to the health of his patients?

    If lawyers make their money from those of us who run foul of the law, do you really think that people like the CJ, AG and various lawmakers (lawyers) REALLY want to achieve a law-abiding society (…and all become beggars?)

    …so here is my point

    The reason we have worsening crime is that our SYSTEMS reward the opposite outcomes to the ones that we claim to desire…
    Even the police force is valued and rewarded for RESPONDING to crime. There is little reward to them in PREVENTING crime.

    The reason that global health is declining in an environment when we know more than we ever knew before and have more technology and science than ever before…. is that we reward the players (doctors, drug companies, lawyers, Druggists, etc) more as health levels decline.
    Read up on the story of aspartame and tell me if you REALLY think world experts are interested in the general good health of people.

    If you think about it, this ‘upsided down’ logic is much more the rule than the exception.

    What I find most surprising about the whole thing is the general acceptance of the status quo.

  22. Georgie Porgie Avatar
    Georgie Porgie

    David
    You will recall from the outset that I said this topic was a technical one. I can assure you that I tried, therefore, to try to make my statements as simple as I could. I repent in sack cloth and ashes for my failure to do so.
    Generally speaking, it is the job of every Barbadian to protect their own health by reading suitable literature and attending public lecturers and quizzing their health care providers. This is not the job of the doctors and the pharmacists.
    Re Can we assume that if there was negative feedback in Australia about Prexige that similar symptoms should exist in any market where human beings exist?
    The answer to that question is YES… and NOT necessarily so.
    Yes, because the drug is cleared mainly by the livers in humans in all markets.
    NOT necessarily so, because there are many factors that come into play with respect to how a drug is handled by different individuals..Individual factors altering drug effects include dosage, diet, age, gender, existing disease, tolerance and physical dependence, compliance, body weight, genetics, chemical properties of drugs
    As I explained in a previous post there are many reasons why we may not see adverse effects in Bim. Among these include how many are using the drug, how many are abusing the drug, if any are responding in unusual fashion to the drug, if very low doses are being used etc
    Barbadians can be satisfied that the local doctors are as you say sufficiently in tune with the fine balance needed to maintain to protect the health of our people in respect to side effects of commonly used drugs. For the last 30 years for sure, regular meetings are held for the doctors by the Drug Houses concerning relevant aspects of drugs used in Barbados. In addition, there is a considerable amount of research done, and several Continuing Medical Education Conferences held annually..
    Our Public Health System is also quite good generally. As I said on another thread, there is a need for our Preventative Public Health System to have more power and facilities (mainly trucks in the seven zones that I propose) that they can act in a more timely manner to eradicate potential public health matters. This is a political and management issue.
    I can assure you gentlemen and ladies, that all the CORRECT SOLUTIONS that will make our Public Health System ideal are known to the authorities. They have been told! I can assure you too that there are Bajans in other parts of the world doing what we need to do and being praised highly for their work, that have been willing to return home to effect these solutions since at least 1994.

  23. Georgie Porgie Avatar
    Georgie Porgie

    Bush Tea
    You make some interesting points, and indeed your ‘upsided down’ logic is much more the rule than the exception, and the general acceptance of the status quo is more fact than fiction.

    Most of us of a certain vintage were well brought up from the home, primary school, Sunday School etc and certain ideals were instilled in us which once used to apply both in our nice little world, and the world at large.

    But somewhere along the way it seems that what we were taught to be right is now wrong, and what we thought was wrong seems to be “right.” ‘Upsided down’ logic it is.

    It is now well known that there is an association with the drug companies and the food companies. Hence the use, or rather abuse of aspartame.

    It seemed logical and harmless to use. After all its just two amino acids joined together. But the truth is that it causes a great deal of harm.

    MSG and other addictive food additives are used to draw people back to fast food joints. These drugs are just as bad as ganja and alcohol. Relatively few people use illegal drugs compared to those who regularly fraternize fast food establishments.

    As you correctly opine, there is a decline in health globally in an environment when we know more than we ever knew before and have more technology and science than ever before….but this is because we reward the entertainers ! LOL

    Seriously, in the USA and thus the world via the cultural penetration of tv commerce is governed by the perceived needs of the baby boomers. These folk tend to have money, tend to be now retired or retiring, want to live for ever, want to be entertained and pampered and all levels and types of market forces target them. Every one else suffers.

    Good old saltfish is expensive as hell but you can get cheap preserved catfish from China on the market.. Drug advertising has been changed to put the doctor under pressure to prescribe.
    The ads go like this ASK YOUR DOCTOR IF YOU DON’T NEED X or Y

    In health care all kinds of unnecessary Xrays and drug tests are ordered by doctors, who live in fear of making mistakes and being sued. So we no longer treat patients, we treat “results.” The aim is to get those numbers right, irregardless to how the patient feels.

    We don’t do that in Barbados, yet I’m sure. (I hope…….I’ve not been home for years)

    With respect to crime, the criminals seem to have more rights than the victims. And judges are clearly asses.

    You ask “Why would a Doctor (who makes his money BECAUSE people get sick) be even interested in protecting the health of Barbadians?

    Because doctors don’t like sick people really. Just think of it? Do you like sick people? Do you like to visit the sick?

    Sick people desire for us to do miracles sometimes……as if we are God . (Some of us believe that we are too). Sick people make me feel helpless! Especially when you cant help them! Sick people make me face my own mortality. Sick people make me feel like a failure. Remember I set out to cure all !

    But I have learned much from the sick about love and life and more important things than money. Things like patience………

    Re If Barbadians were perfectly healthy then these professionals would become beggers.
    Not really. There are hyperchrondriacs and other ways to make money.

    Pharmacists actually make most of their money from their front stores not their dispensaries, especially when there are limited mark ups for POM drugs..

    Re If you were a doctor, would you dedicate yourself to educating your potential customers to avoid having to require your services?

    Yes. It’s a good thing. It has rewards.
    I taught my mothers what to buy and keep at home in the fridge for use WHEN their children would get ill,with certain common childhood illnesses, so that I wont come out at night. In the end those children grew up and became my patients, and their children too LOL

    I bought medicine from the Drug Houses at the wholesale price for my patients. I could go on. But Im not normal.

    Bush Tea I must agree that we have to spend more time studying your ‘upsided down’ logic since it is more fact than fiction.

  24. Idealist Avatar
    Idealist

    To further support BT’s upside down theory.
    Aspartame—more proof that US politicians put profit before people.

    After Ford’s defeat, in 1977 Donald Rumsfeld and friends were at a loose end, and in casting around for lucrative employment these Mr Fixits took over the management of Searle & Co., an almost bankrupt pharmaceutical firm, and in particular its discredited product Nutrasweet ( Aspartame ).

    Seeing this as the company’s salvation the new management team under CEO Rumsfeld, set out to overturn all objections and gain the Food and Drug Administrations approval.

    They could not refute the strong scientific evidence of brain seizures and tumours, so they played to their strengths and planned a legal and political assault on the FDA’s rulings, using their extensive contacts, willpower and force.

    On Reagan’s inauguration in 1981 power was restored to Rumsfeld as he joined the new government, and the success of his lobbying was apparent immediately.

    On Reagan’s second day in office, he suspended the FDA’s authority to police their decisions.

    Within his first month the new president had sacked the head of the FDA and put in place his own commission.

    Rumsfeld, a member of Reagan’s transition team, quickly saw his project come to fruition, when, against all medical studies, the new improved FDA after some gerrymandering by its chairman, gave Nutrasweet its blessing.

    We need Nutrasweet like a hole in the head, in fact that is what scientific studies show it causes, spongified brains.
    Now this brain-number is everywhere and in everything.

    Just a short précis of events, but an interesting case study of how business operates in the USA, and how if one drug can make the general population sick we can sell them more drugs to counter the first one.

  25. Wishing in Vain Avatar
    Wishing in Vain

    When one considers that this adminstration has malspent in excess of $ 750 million of our taxpayers dollars, in the VECO PRISON PROJECT, DANOS 3 S ROAD WORKS PROJECT, GREENLAND, NEWTON UNFINISHED BUILDING, BATHS, RURAL DEVELOPMENT COMMISSION, URBAN DEVELOPMENT COMMISSION.

    However we cannot find the $ 300.00 needed to take care of the sight needs of this little boy?

    It is an absolute disgrace to the gov’t and to the people of Barbados for something such as this to have taken place in this society when we have so many of Owing’s friends and himself and his cabinet living sweet off of the hog and the rest of us honest citizens catching hell.

  26. Wishing in Vain Avatar
    Wishing in Vain

    It most certainly is in a large mess, what a disgrace to those that have no choice and no where else to seek attention and care.

    This whole island seems to be on auto pilot and with no skipper in charge.

    The case was made even worst by the sick actions of the person that violated the dead persons body.

    Where are we heading?Does anyone have a clue?

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