Pradaxa Side Effects
Common side effects of the blood thinner Pradaxa include upset stomach, vomiting and tiredness. Patients may experience serious bleeding events while taking Pradaxa and an increased risk of blood clots after stopping the drug. Packaging includes a boxed warning for these potentially fatal events.
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- Common Side Effects
- Bleeding, upset stomach, nausea and vomiting
- Serious Side Effects
- Serious bleeding, allergic reactions and an increased risk of stroke upon discontinuation
- Boxed Warning
- Pradaxa has a boxed warning for an increased risk of stroke after discontinuing the medication and the possibility of hematomas in patients who undergo certain spinal procedures.
Most Recent Pradaxa Side Effects Information
As of June 30, 2024, bleeding, and stroke are the most common Pradaxa side effects reported to the U.S. Food and Drug Administration. Gastrointestinal hemorrhaging is the most commonly reported type of bleeding. Bruising, dizziness and fast or irregular heartbeat were other frequently reported adverse reactions.
Over 75% of the adverse events reported to the FDA were serious. The number of reported cases peaked in 2011 and remained high through 2014. This coincides with the release of FDA safety warnings for many of the most reported side effects.
FDA Adverse Events Reporting System (FAERS) Data for Pradaxa Side Effects | |
---|---|
Total cases reported | 63,227 |
Serious cases (including deaths) | 48,103 |
Deaths | 9,761 |
Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.
Serious bleeding may occur when taking the blood thinner Pradaxa. The FDA requires its packaging to contain a warning about the risk of spinal and epidural hematomas. This is a condition where blood pools along the spine during certain medical procedures. There is also a warning about how stopping Pradaxa may increase your risk of stroke.
Because some of these effects can be severe, you should talk with your doctor about the risks of taking Pradaxa before you start treatment.
Common Pradaxa Side Effects
Bleeding, sometimes serious, is the most common side effect of Pradaxa. Additionally, over 15% of patients taking Pradaxa experience adverse gastrointestinal effects. These include abdominal pain, gastritis, gastroesophageal reflux disease (GERD) and gastric bleeding.
- Abdominal pain
- Bleeding
- Stomach inflammation
In clinical trials, gastrointestinal bleeding was more common among patients taking Pradaxa compared to those on a different blood thinner called warfarin.
“To minimize the gastrointestinal issues, Pradaxa can be taken with meals,” clinical pharmacist Kenneth S. Fill told Drugwatch. “Be extra cautious during physical activities to reduce the chance of minor or major bruising.”
Serious Pradaxa Side Effects
Bleeding risks, such as hemorrhaging, gastrointestinal bleeding and stroke are serious potential Pradaxa side effects. Gastrointestinal and internal eye bleeding were the most common types of bleeding reported in clinical trials.
There is also a risk of hematomas (pooled blood). In rare cases, patients reported severe allergic reactions, including anaphylaxis, when taking Pradaxa.
- Allergic reactions
- Hemorrhaging (severe bleeding)
- Stroke
Several side effects from Pradaxa, an anti-coagulant manufactured by Boehringer Ingelheim, are serious. They may cause life-threatening complications such as excessive bleeding and stroke.
“Signs and symptoms to look out for include unusual or prolonged bleeding, excessive bruising, and blood in the urine or stool,” Fill said.
Notify your doctor immediately if you notice any symptoms of bleeding disorders. However, you generally shouldn’t stop taking Pradaxa without speaking to your doctor.
“Stopping Pradaxa abruptly can lead to a rebound effect where the risk of blood clots increases,” Fill said. “This is particularly dangerous for those that are prone to or at a high risk of stroke or thromboembolism.”
FDA Boxed Warnings
The boxed warning for Pradaxa’s prescribing information covers two conditions: thrombotic events and epidural or spinal hematomas. Boxed warnings are the most serious drug label warning the FDA issues.
Because there is an increased risk of blood clots among patients who discontinue treatment with Pradaxa, the boxed warning cautions against stopping an anticoagulant without replacing it with another medication.
Additionally, in patients taking Pradaxa, blood may pool against the spine during spinal punctures and certain types of spinal anesthesia. This condition, called a spinal hematoma, can lead to permanent paralysis.
Blood Clots
Patients have an increased risk of developing blood clots when they stop taking Pradaxa. This can cause serious complications, including stroke and death. The most recent FDA review indicates this risk is lower than early studies suggested, but it is still a concern.
Major Bleeding Events
Pradaxa is directly associated with an increased risk of serious bleeding events.
Notify your health care provider right away if you notice symptoms of a bleeding event. If you take Pradaxa, be aware of symptoms of serious bleeding disorders that require immediate medical attention.
- Bleeding from your gums
- Frequent nose bleeds
- Heavy periods
There is mixed evidence on how Pradaxa compares to other blood thinners. A 2019 study in the American Journal of Medicine examined the safety profiles of several blood thinners in Medicare patients. The results showed a slightly decreased risk of internal bleeding in the brain or skull when taking Pradaxa compared to similar medications.
However, a 2021 meta-analysis published in Frontiers’ Journal of Pharmacology found that Pradaxa has an increased rate of gastrointestinal bleeding, and an older 2014 article from the Journal of the American Heart Association found that patients on dabigatran, the active ingredient in Pradaxa, have a 33% increased risk of heart attack compared to warfarin users.
Careful monitoring can reduce the dangers of major bleeding and related complications.
Multiple patients filed Pradaxa lawsuits claiming serious injury from bleeding events. However, the litigation has been closed.
Case Study: John Wilchinski’s Cerebral Hemorrhage After Pradaxa Use
John Thomas Wilchinski, a resident of Greenville County, Tennessee, was prescribed Pradaxa in February 2011. After just two months of use, he suffered a severe cerebral hemorrhage, according to court documents. This is a life-threatening type of bleeding in the brain. This serious side effect has had lasting impacts on his health and well-being.
Permanent Injuries
As a result of the cerebral hemorrhage caused by Pradaxa, Wilchinski faced permanent injuries. These include ongoing physical pain, mental anguish, and diminished enjoyment of life. His condition requires lifelong medical treatment and continuous monitoring.
Ongoing Health Concerns
The side effects of Pradaxa left Wilchinski with a fear of future health complications. His experience highlights the significant risks associated with Pradaxa. Especially challenging was the lack of a reversal antidote at that time. This made managing his bleeding events extremely difficult, according to court records.
While Pradaxa has an antidote called idarucizumab, the FDA didn’t approve its use until 2015. Wilchinski’s incident occurred in 2012.
Management Tips for Pradaxa Side Effects
You can address most mild reactions at home. Taking Pradaxa with food, using antacids approved by your doctor and avoiding situations with a high risk of injury can help mitigate minor side effects.
Taking Pradaxa with food can reduce many gastrointestinal symptoms. It may also help limit the risk of ulcers associated with medication use. Using water to swallow Pradaxa, rather than dry swallowing, can also decrease your risk of ulcers.
Antacids are generally effective for managing upset stomach and heartburn. It’s a good idea to check with your doctor before taking any over-the-counter medicines to ensure they won’t interfere with your prescription. If an OTC medication does not help, you may need a prescription medication to ease symptoms.
Exercise caution when handling sharp objects to help reduce the risk of bruising and excessive bleeding. You may also want to avoid activities that have a high risk of injury.
Pradaxa Alternatives
There are many available blood thinners, such as Eliquis, Xarelto and warfarin.
Eliquis, Xarelto and Pradaxa all belong to a drug class called direct oral anticoagulant. These medications work by interfering with the proteins your body uses to form blood clots.
Warfarin is an older type of blood thinner called a Vitamin K antagonist. While Vitamin K antagonists are older and more studied, they also have more risks and drug interactions compared to direct oral anticoagulants.
Many of these alternatives carry side effects similar to those of Pradaxa. Discuss your options with a doctor to see which one is the best fit for your medical history.
Editor Lindsay Donaldson contributed to this article.
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