New Blood Thinners Pose Serious Health Risks
For patients with atrial fibrillation, the number one blood thinner over the past 35 years was Coumadin (warfarin). Although this drug is very successful at thinning the blood and thereby preventing heart attacks and strokes, it is also a very dangerous drug that interacts with almost every other drug, many foods, and requires dose monitoring through constant blood tests called INR (International Normalization Ratio).
The newest entry into the blood thinning market is Pradax and it has been a very big seller because it was supposed to be a lot safer and it did not require monitoring blood tests; (as often as every 2 weeks with the drug Coumadin). The manufacturer, Boehringer Ingelheim, also claimed that it did not increase the risk of bleeding in the brain which is a very notable side effect of Coumadin. As it happens so often, all the studies before the release of the drug indicate it is totally safe and then after the drug is dispensed to people who are actually ill, the side-effects and the deaths start to show up.
A study completed at the end of last year by the United States Food and Drug Agency showed that since the introduction of Pradax, there have been 459 deaths directly attributed to the use of this drug; there were 69 permanent disabilities and 1331 hospital visits directly related to the prescription use of this blood thinner.
One of the problems of drug studies is that when they are controlled by the manufacturer, they administer the drug to young healthy people with the results being that very few problems or side-effects show up. However, once the drug is on the market and it is dispensed to people who are elderly and have heart conditions then we see the true action of the drug and that is when the side-effects and the deaths occur.
In January of this year a study published by researchers at the Cleveland Clinic in Ohio found that the new drug, Pradax carried with it a higher risk for heart attacks than the older drug, Coumadin. Of course if the initial studies had been honest with the correct demographics, it is possible that the drug may never have been approved.
It seems that the older drug Coumadin which required constant INR blood tests was very short-acting and this meant that the drug did not last too long in the body and the dose could be adjusted depending on the blood tests. The new drug, Pradax, stays in the body for much longer periods of time and the blood-thinning effects are not easily reversible. This has led to many patients suffering massive brain hemorrhages following routine falls.
Now that the drug is being used by millions of people, Health Canada has decided to do a safety investigation of Pradax and another new blood thinner known as Xeralto. You would think that when they approved Pradax (dabigatran) in 2010 they would have performed their own due diligence rather than depend on the studies submitted by the manufacturer. These blood thinners belong to a whole new class of drugs and many more will be coming on to the market in a few years. Will Health Canada be more careful before they approve any more members of this drug family? I doubt it.
Atrial fibrulation is one of the most common types of heart arrhythmia and the Heart and Stroke Foundation estimates that 350,000 Canadians have this condition which increases your risk of stroke fivefold. A rapid, irregular heartbeat can cause blood to pool in the heart's chambers, increasing the risk of clotting and hence having a stroke. Coumadin (warfarin) thins the blood enough to prevent this process but Pradax was supposed to be safer and more effective.
Boehringer Ingelheim, the manufacturer and hundreds of cardiologists that are strongly influenced by this company deny that Pradax is dangerous and claim that the old drug, Coumadin was much worse but adverse reactions were not reported because it was simply part of the action of the drug. With Pradax being a new drug, there have been thousands of adverse reaction reports simply because it is a new drug. In fact, one of these doctors, Jeffrey Weitz, professor of Medicine and Biochemistry at McMaster University here in Hamilton was involved in the development of Pradax and has received financial compensation directly from Boehringer Ingelheim. He calls the adverse reaction reports and the deaths “fear mongering.” If the death of my mother or father was related to their use of Pradax I would not call it “fear mongering” but that is what happens when big dollars are at stake.
On the other hand, William Geerts, a thrombosis specialist at Sunnybrook Health Sciences Centre in Toronto says that he is taking a cautious approach and will not prescribe these new anticoagulants until more real information is available.
Any time a pharmaceutical company can market a prescription drug that has to be taken every day for the rest of a person’s life, the greed factor forms a large part of the equation. They will test the drug in foreign countries and pick young healthy individuals to get the optimum results. This should not be allowed. As long as each one of us is unique from the other with our own personal DNA, drugs should be thoroughly tested in all segments of the population. Did you know that African Americans metabolize drugs in a totally different way than Latinos or Caucasians? There has been a significant amount of research that has led to very specific drugs being used to control blood pressure in the black populations and completely different drugs for white people and Asians.
The United States Food and Drug and Health Canada should demand this very extensive type of drug testing before approving very dangerous drugs that have the potential to kill us.
Health Disclaimer. Copyright ©2012. Published with permission. Barry Goldman practiced as a pharmacist for 35 years. He belongs to the Canadian Pharmaceutical Association and the Canadian Health Food Association.