Approved for distribution by the U.S. Federal Drug Administration (FDA) in 2010, Pradaxa is a prescription blood thinner that was designed to help prevent the formation of blood clots. Unfortunately, almost immediately after its release, the FDA began receiving reports that the drug caused uncontrolled bleeding, stroke, and hemorrhages, which in some tragic cases, proved deadly for patients. In response, many victims filed lawsuits against the drug’s manufacturers alleging that the company failed to warn users of these side effects. If you took Pradaxa and suffered uncontrolled bleeding or another serious adverse effect, it is critical to speak with an experienced Pradaxa lawyer who can help you collect compensation for your losses.
Side Effects and Complications
The body prevents uncontrolled bleeding by forming clots. Unfortunately, this can cause serious health complications, such as strokes and serious heart conditions in certain patients. Pradaxa was meant to address this by inhibiting a clotting enzyme called thrombin, and while highly effective at reducing the chances of naturally occurring clots, the drug also disables the body’s ability to stop bleeding after internal injuries. For this reason, Pradaxa users are more prone to gastrointestinal bleeding and hemorrhages in the brain and central nervous system, as well as:
- Heart failure;
- Acute kidney failure;
- Liver failure;
- Abdominal pain;
- Gastroesophageal reflux disease;
- Gastrointestinal ulcers;
- Allergic reactions; and
- Skin rashes.
Although not all of these reactions are life-threatening, severe internal bleeding and heart failure are potentially deadly.
Failure to Warn
Drug manufacturers are required to conform to certain standards when they produce prescription medications. For instance, companies must warn consumers about the known dangers associated with taking their products and are required to conduct extensive testing prior to release. Unfortunately, within a few years of Pradaxa’s entrance onto the market, discrepancies between the results published by Pradaxa’s maker and real-world clinical practice came to light. Aside from extrapolating trial data into clinical practice, the manufacturer also allegedly failed to conduct post-marketing surveillance and adverse-event reporting, which made it much more difficult to detect groups whose risk factors were not as apparent as those exposed in a clinical trial setting. Finally, a number of claimants have accused the manufacturer of:
- Failing to provide adequate dosing information on the drug’s label;
- Misrepresenting the safety and effectiveness of the drug compared with alternatives;
- Using deceptive marketing practices;
- Failing to disclose the risks associated with taking the drug;
- Failing to provide an antidote for those who suffer from uncontrolled bleeding after taking the drug; and
- Failing to research the drug’s safety and establish variable factors when recommending dosages.
In response to these claims, Pradaxa’s manufacturer, Boehringer Ingelheim agreed to settle approximately 4,000 state and federal lawsuits for $650 million. To learn more about filing your own claim, please contact a member of our legal team today.
Call an Experienced Pradaxa Lawyer
Please contact Fox Willis Burnette, PLLC at (866) 862-4855 to discuss your own Pradaxa-related health problems with an experienced dangerous drug lawyer. A member of our legal team is standing by and eager to help you throughout each step of your case.