Recalled Dabigatran Blood Thinners
- Bottles of dabigatran etexilate capsules (brand name Pradaxa) were voluntarily recalled due to the presence of a chemical that may increase the risk of cancer.
- The chemical is called nitrosamine, and the FDA says exposure to higher levels of it over longer periods may increase the risk of cancer.
- The drug was found to have levels of nitrosamines higher that what the FDA says is acceptable.
- Our experts say the cancer risk from nitrosamine is low and that you should not stop taking your blood thinner as your doctor prescribed.
- Our experts suggest speaking with your doctor, who can help you understand your unique situation and evaluate the benefits of you taking the drug vs. any possible risks.
Ascend Laboratories voluntarily recalled bottles of dabigatran etexilate capsules. Sold under the brand name Pradaxa, it’s a novel oral anticoagulants that has become increasingly common “to treat life-threatening blood clots in people,” says Dr. Marc Eisenberg, cardiologist at Columbia University Medical Center/NewYork-Presbyterian Hospital and an associate professor of medicine at the Columbia University Medical Center.Read More
Why Was Pradaxa Blood Thinner Recalled?
Ascend Labratories voluntarily recalled bottles of the blood thinner due to the presence of a chemical called nitrosamine. This category of chemicals is “found in both natural and human-made products at low levels,” said says Dr. Keith Keith Cengel, a radiation oncologist and an associate professor at The Hospital of the University of Pennsylvania, Perelman School of Medicine.
Nitrosamines are commonly found in water and foods, such as grilled and cured meats, dairy products and vegetables, as well as drugs.
But The FDA says exposure to higher levels of nitrosamine over long periods of time may increase the risk of cancer. So the agency set a threshold for the amount of nitrosamines that’s acceptable for people to be exposed to, called the “acceptable daily intake.”
The dabigatran etexilate capsules were found to have levels of nitrosamine above the acceptable daily intake level. When drugs contain levels above the FDA’s threshold, the agency recommends the drugs be recalled.
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What Is the Cancer Risk From Nitrosamines?
The risk of cancer from nitrosamines is low and not fully understood for humans, says Dr. Cengel.
“In general, the risk of drugs with elevated levels of nitrosamines, especially over the short term, is a very small risk of health problems in the more distant future,” Cengel told SurvivorNet.
While the FDA warns that nitrosamines may increase cancer risk over the long term, Cengel explains that the medical community is still working to understand the “absolute level of risk.”
Cengel added that nitrosamines exist in drugs “as very low-level impurities,” and that this blood thinner is not the only drug to be subjected to a voluntary recall. “There have been a number of drugs found to contain levels of nitrosamines over the established thresholds with similar voluntary recalls,” he said.
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Should You Stop Taking Your Dabigatran Blood Thinner?
Experts suggest that you continue taking any prescribed blood thinner and then discuss your concerns with your doctor.
“If you are taking Pradaxa at this time, do not abruptly stop this medication,” says Dr. Eisenberg, who also authored a user-friendly guide to common symptoms and what to do about them.
That’s because, as Dr. Cengel stresses, your doctor ordered you to take them to help prevent serious health issues like blood clots – which can lead to potentially deadly stroke or heart attack.
“If you are on blood thinning medications, this is because your doctor worries about short-term risk of major problems from blood clotting in the near future,” Cengel said. He explained that if you stop taking your prescribed blood thinner, “you could be trading a theoretical small future risk by continuing the medication for a much larger and more immediate risk if you stop the medicine.”
Dr. Eisenberg suggests calling your pharmacist for help determining if your bottle of dabigatran is one that has been recalled. If it is, your pharamacist may suggest other medications you could switch to. And in that case, you may want to “call your doctor right away and see if you should be switched to another medication,” which could include rivaroxaban (brand name Xarelto) or apixaban (brand name Eliquis),” Dr. Eisenberg said.
Cengel said your doctor who prescribed your blood thinner “is in the best position” to help you understand your unique circumstances — why they prescribed blood thinners in the first place and risks you may face by not taking them. If you are concerned at all about your medication and a possible cancer risk, your doctor can help you evaluate the benefits of taking the drug vs. any possible risks.
Heart Failure and Blood Clots
Heart failure is a condition that affects the heart’s ability to pump blood efficiently. It doesn’t actually mean the heart is “failing” to work, but that it is not functioning as well as it could be. Because the heart is struggling to meet the body’s needs, fluid backs up in the body, and organs do not get as much blood as they need.
Heart failure slows the flow of blood, which has the potential to cause blood clots to form, according to the American Heart Association. While blood thinners are not typically prescribed to treat heart failure, they may be used if you also have A-fib, as Dr. Eisenberg said, or another heart problem.
For more information on heart failure, SurvivorNet has expert resources on symptoms, causes, and treatment options.
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