Approved by the Food and Drug Administration (FDA) in 2010,1 Pradaxa® (dabigatran etexilate) is a popular blood thinner (anticoagulant). When first introduced to the market, the makers of Pradaxa boasted better benefits and lower risks than previous blood thinners, like Coumadin®.2 However, a patient taking different types of medicines has to be careful about the medications he or she mixes, which when combined with Pradaxa may result in serious side effects. One class of drugs that does not mix well with the popular blood thinner Pradaxa is the category for anti-inflammatory pain relievers called NSAIDS.
What is an NSAID?
NSAIDS are non-steroidal anti-inflammatory medications.3 Common over-the-counter medications, such as aspirin and ibuprofen, are NSAIDS.
Taking NSAIDS has many benefits, including easing pain and arthritis symptoms. These anti-inflammatory pain relievers also reduce fevers and inflammation, and they can even stop blood from clotting. That’s why some doctors recommend them as a heart disease preventative. While many are more familiar with what an NSAID is, they are less familiar with the side effects of NSAIDs. Long-term use of these anti-inflammatory pain relievers can cause stomach upset, bleeding, kidney problems, and an increased risk of bruising.
NSAIDs and Pradaxa
Pradaxa product information cautions patients about using NSAIDS with the blood thinner. Specifically, patients are warned that taking Pradaxa with NSAIDS increases the risk of bleeding, which can be fatal. Significant bleeding is among the side effects that both NSAIDs and Pradaxa share. An NSAID when used with Pradaxa puts a patient at greater risk for serious, possibly fatal, medical issues.
Pradaxa Symptoms and Side Effects
Following two December 2011 notices, the FDA offered the public and doctors more information about serious problems with Pradaxa and issued a warning for certain patients to avoid using the blood thinner. Patients having problems with Praxada might present with the following symptoms:4
- Bleeding gums
- Pink or brown urine
- Bruises that increase in size
- Coughing or vomiting blood
- Frequent nose bleeds
- Red or black stools
These symptoms are hints of a greater problem with the popular blood thinner. These serious Praxada side effects include:5
- Bleeding, intracranial and gastrointestinal (stomach and intestines)
- Heart Attack
- Blood clots (in vessels/value of the heart)
As a result, the FDA will continue to monitor the safety of Pradaxa and health care professionals are cautioned to monitor their patientss closely.
Praxada Product Liability Lawsuits
By 2012, the FDA had received reports of over 500 deaths and nearly 4,000 complaints linked to Praxada.6 Pradaxa has yet to be recalled, though hundreds of personal injury and product liability lawsuits have been filed against the maker of this blood thinner.7
Since 2010, millions have been prescribed Pradaxa and millions continue to use the prescription with over-the-counter NSAIDS. Still, the number of prescriptions only accentuates the number of people who may become victims of such a harmful medication.
Drug makers have a duty to produce safe medications for doctors to prescribe and people to use. The makers of Pradaxa have failed in this duty. If you or someone you know has suffered from Pradaxa side effects or complications, legal rights and remedies exist. Contact an experienced product liability lawyer to help you understand and protect your rights.