TRANSLATED FROM DUTCH:
It is estimated that the use of diclofenac in the Netherlands, caused four deaths per week. These deaths are avoidable, why that does not happen? In Labyrinth radio conversation with Ruud Coolen van Brakel, director of the Institute for Responsible Medication Use, and Ivan Wolffers, professor of health and culture, doctor and writer.
The reason for this meeting was the following article, which appeared onwetenschap24.nl later NPOwetenschap called and now the Nu Knowledge called (who said that the public broadcaster was not dynamic?)
In September 2016, I published an article in Trouw about the dangers of diclofenac and the possible alternatives.
March 12, 2013 – diclofenac, a widely used analgesic and anti-inflammatory, increases the risk of heart attacks and strokes. It’s been known for years, but that knowledge is done surprisingly little, especially in the Netherlands. Hundreds of preventable deaths are apparently no reason for urgency.
There is a pill that kills people every day, while there is a good alternative that she would leave alive. Yet little is done to ensure that puts an end to this. Clinical pharmacologist Patricia McGettigan: “The regulators react extremely slowly. Leadership is lacking. They do not seem to realize that their inertia takes people daily life. ”
McGettigan, a researcher at London’s William Harvey Research Institute, says that the ball started rolling after the introduction of Vioxx (generic name: rofecoxib), a newly developed anti-inflammatory painkiller which is NSAID. In 1999, manufacturer Merck brought this product on the market, the sale was discontinued worldwide in 2004. The reason was that users had an increased risk of heart attacks and strokes. The scandal became worse because the manufacturer was aware of the risks, but had tried to keep information secret. The Vioxx affair Merck has billions of euros in compensation cost for victims. So much, that the pharmaceutical giant there has gone almost to underneath.
After it was found that Vioxx was dangerous, “came a wave of research into the risks of NSAIDs in motion,” said McGettigan. It soon became apparent that there were more problematic pills. New, but also old. Including the most commonly prescribed painkiller in the world, including the Netherlands # 1: diclofenac. Here it was prescribed 2.8 million times in 2011 and it is also for sale without a prescription.
Patricia McGettigan along with colleague David Henry spent years with NSAIDs and their risks. In 2006, the two wrote a review article on the basis of all relevant research. Diclofenac proved just as Vioxx, increase the risk of heart attacks and strokes by more than 40 percent and even double in high doses. Naproxen, an agent that works just as well, does not give such an increased risk. The logical advice was to reduce as fast as possible the use of diclofenac, and replacing it with naproxen.
Of course, not everyone agrees. A spokesman for Novartis, which diclofenac sells under the brand name Voltaren, said in 2006 that there were a lot of data which showed no increased risk. So it would be premature for it to be action.
The knowledge of these risks has since become bigger and more reassuring was not all. In 2011 MdGettigan and Henry came back with an overview. Came diclofenac as bad as Vioxx off the bus. But the evidence was therefore even stronger. McGettigan: “In addition to observational studies, which looked at how many heart attacks and strokes occur among users, there are also direct comparative studies have been conducted with different NSAIDs. The results agree well: diclofenac is as dangerous as rofecoxib [Vioxx – EV] while naproxen shows no increased risk.
What has been done with that knowledge? Which have McGettigan and Henry studied for fifteen countries – the Netherlands was not among them. The outcome is in this article in PLoS Medicine . And that is disappointing: diclofenac remains by far the most commonly used NSAID. In 2011, this agent in the countries studied was sold three times as much as naproxen, the number three. Diclofenac is in 73 countries on the list of essential drugs used by the government, naproxen in only 27 countries. McGettigan: “There would diclofenac should be removed as quickly as possible. Countries look to that list often to the World Health Organization, and which, while not guessed it, but has also yet to hear any warning. We try now so far to get them to take action; I talk about it next month. ”
Voltaren is one of the names is diclofenac for sale. Spreads such as Voltaren Emulgel is moreover thought to pose no risk because they work locally.
As long as you talk about percentages increased risk, it all seems not so urgent. Let’s look to England to make it more concrete, says McGettigan.”The care authority MHRA says that by 1000 diclofenac users occur three additional heart attacks and strokes. That sounds fairly harmless, until you look at the number of users. In England, diclofenac 4.8 million times prescribed in 2011. ” Incidentally, though fallen, because in 2005 there were 8 million. In the Netherlands, the use of diclofenac in the same period just huge. It is not in the top 10 in 2005, so was then prescribed less than 700 thousand times. In 2011 it was increased to 2.8 million times, at least four times so.
That 4.8 million British recipes, how many users are they? It is not clear, because many people get multiple prescriptions. McGettigan treasure after a calculation which “three in a thousand” in this number amounts to about 1,800 additional cardiovascular events, including 600 fatal.”And Danish data suggest that my calculation is too conservative. At high doses of diclofenac doubled namely the added risk, so you have six additional incidents per 1,000 users. If you assume that 250 thousand British patients use such a high dose, fall into that group alone 500 preventable deaths. ”
Who is actually responsible for this? “Formally, it is always the prescribing physician. But I think regulators and the MHRA and WHO also bear responsibility. They let things take their course and thereby implicitly giving the impression that it is a safe drug. ”
Four deaths per week
What is the situation in the Netherlands? The guideline for the use of NSAIDs, which still stands, was drawn up in 2003, when there was still little known about the cardiovascular risks of the various resources. Indeed, “Among its supposed benefits: reducing the risk of cardiovascular disease” can be read in the introduction. Outdated information so.
2.8 million prescriptions plus an unknown number of users without a prescription, was diclofenac in 2011 in any case the most commonly used NSAID . We Passes McGettigan calculations thereon to, then it is likely that diclofenac use in the Netherlands this year has caused at least 200 preventable deaths, about four per week so.
The figures will not be much different this year, because the treatment guidelines is still the same and additional warnings absence. The risk is therefore still underestimated. If I ask for it at the Institute for Responsible Medication I get the following response from director Ruud Coolen van Brakel ‘Actually know all NSAIDs increase the risk of heart problems, including ibuprofen, naproxen and the like. In Britain, the subject very pregnant and is widely called no diclofenac but instead due to naproxen. We have already asked in the Netherlands, decide whether such prescriptiewijziging here for the agenda, but both the registration authorities and the professional groups for this was no sense of urgency. ”
The urgency is also not spatter from the College Medicines Evaluation. Press Officer Jasper Hugo Brouwer: “It is true that diclofenac at high doses has a corresponding risk of Vioxx (rofecoxib). All NSAIDs are to be reviewed at European level following the debate surrounding Vioxx and, consequently, be included in the product contraindications and warnings to improve the safe use of these resources. This type of evaluation of medicinal products is a continuous process. The most recent evaluation took place last October. The CHMP, the scientific committee of the European Medicines Agency (EMA) in which the College is represented Medicines Evaluation Board (MEB), concluded that the latest scientific research on the cardiovascular risks associated with the use of NSAIDs are in line with previous conclusions. Diclofenac has in comparison to other commonly used NSAIDs (ibuprofen, naproxen), a slightly less favorable cardiovascular risk profile. Currently viewing the Pharmacovigilance Risk Assessment Committee (PRAC), where the Dutch MEB is represented, or the product of diclofenac should be strengthened further. See also the web message on our website . ”
Indeed mails the information officer of the European Medicines Authority: “The EMA is very aware of the issue and in October 2012 launched a review to determine the cardiovascular safety of medicinal products containing diclofenac. That just about for systemic use [so no spreads as Voltaren Emulgel – EV]. The EMA will weigh the latest information in the risk assessment and consider whether the existing treatment advice should be adapted in order to cardiovascular risks. More information about that can be found on our website . ”
In short, are not true measures taken so far. There is at most examine whether the warnings in the package insert is not what should be sharply worded. Meanwhile diclofenac in the Netherlands more than ever swallowed, despite the “slightly unfavorable cardiovascular risk profile” which most likely leads to hundreds of preventable deaths each year. Without fuss. That stands in stark contrast to the Vioxx affair, or the recent spate of reports of Diane-35, a pill that ‘ possible eleven deaths has “on his conscience.