The popular novel oral anticoagulant (NOAC) drug Pradaxa (dabigatran etexilate mesylate) is one of the most-prescribed medications in its class, with sales of the blood-thinner soaring to $1.2 billion in 2014. Offering greater convenience than drugs such as warfarin, the U.S. Food and Drug Administration approved Pradaxa in 2010 for the prevention of blood clots and strokes.
Manufactured by Germany's second-largest pharmaceutical company, Boehringer Ingelheim, Pradaxa is linked to recent studies indicating the drug may cause uncontrollable internal bleeding in some patients. If you were recently prescribed Pradaxa, you may have questions about this treatment. Read on to learn more about Pradaxa, including how it works, who takes it, and possible side effects.
How Does Pradaxa Work?
NOAC drugs such as Pradaxa (as well as Bayer's Xarelto®, and Pfizer and Bristol Myers-Squibb's Eliquis®) stop the clotting process by inhibiting the enzyme thrombin, which enables platelets to stick together and form dangerous clots. This is a completely different mechanism of action than that used by older anticoagulants like warfarin, which inhibit clotting by reducing the amount of vitamin K in the blood.
While Pradaxa and warfarin have both been found to be effective in the prevention of blood clots and strokes, Pradaxa rose in popularity by offering patients greater freedom and convenience. Unlike warfarin, Pradaxa doesn't require patients to submit to regular blood tests or avoid vitamin K-rich foods such as kale and other leafy greens, spring onions, Brussels sprouts, cabbage, broccoli, or fermented soy products.
Who Takes Pradaxa?
In 2010, Pradaxa received approval by the U.S. Food and Drug Administration (FDA) for use in the prevention of blood clots and strokes in patients with abnormal heart rhythm and atrial fibrillation not caused by a heart valve problem. Respectively, these heart conditions affect approximately 2.7 and 2.5 million people in the United States.
Pradaxa is prescribed for both men and women. A Canadian study published in Circulation: Cardiovascular Quality and Outcomes in October 2015 found that women had a higher baseline risk of stroke and responded particularly well to twice daily doses of Pradaxa.
The FDA approved Pradaxa for use by adult patients; safety among pediatric patients has not been studied or confirmed. The age of those taking Pradaxa can vary wildly. However, most patients prescribed Pradaxa are 55 or older.
Pradaxa Side Effects and Complications
Although Pradaxa is shown to effectively prevent blood clots and strokes in indicated patient populations, use of this drug isn't without risk. Pradaxa can cause a number of uncomfortable and undesirable side effects, including:
- Upset stomach
- Stomach or abdominal pain
- Minor bleeding (such as nosebleeds)
- Skin rashes
However, the most concerning side effect or complication associated with Pradaxa is uncontrollable internal bleeding. This complication has claimed the lives of more than 500 patients since the drug's approval in 2010, and abnormal bleeding continues to be the leading cause of death for Pradaxa patients.
Patients should seek immediate medical care if they notice any of the following symptoms:
- Swollen or painful joints
- Weakness or fatigue
- Unexplained bruising
- Bloody urine or stools
- Abnormally heavy menstrual bleeding
- Tiny purple or red dots underneath the skin
- Cough that produces blood, vomit or a substance similar to coffee grounds
- Unusual rectal, vaginal, mouth, or nose bleeds
If you're concerned about serious Pradaxa-related side effects, talk to your doctor. Don't stop taking the drug abruptly, as quitting the medication “cold turkey” can increase the risk of stroke.
Are You Considering a Pradaxa Lawsuit?
Did you experience a serious bleeding event while on Pradaxa, or lose a loved to a Pradaxa-related bleeding complication? If so, you may be able to take legal action and pursue compensation from the drug's manufacturer. Contact McGartland Law today to schedule a free initial consultation. Our firm's skilled personal injury attorneys are eager to discuss the details of a potential Pradaxa lawsuit with you.