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Pradaxa is a blood thinning medication approved to reduce the risk of strokes in patients with a form of irregular heartbeat, called atrial fibrillation. Unfortunately, the drug may have deadly side effects. Pradaxa can cause deadly hemorrhaging, and unlike the alternative drug, Pradaxa has no antidote.
With no good monitoring method, the drug may increase risks for some people. We already know that the drug has been associated with high numbers of adverse events, including more than 500 severe hemorrhages, including fatal hemorrhages.
If you or a loved one has suffered serious bleeding or other complications as a result of using Pradaxa, lawyers at Colling Gilbert Wright & Carter may be able to help you get compensation for your injuries. To learn more about your legal rights, please call (855) 880-4741 for a free case evaluation in Orlando, Florida.
What Is Pradaxa?
Pradaxa was approved in October 2010 for stroke prevention in patients with a type of irregular heartbeat. It was the first new blood thinner approved in the US since 1954, and leads a line of similar drugs that are expected to go on the market in the next few years. All are expected to become highly profitable because they promise a number of advantages over the current treatment, warfarin.
These promised benefits include:
- No need for regular testing
- No dietary or drug interactions known to be dangerous
- Rapid onset of effects
On the basis of these benefits, the American Heart Association, the Heart Rhythm Society, and the American College of Cardiology, asserted the drug’s benefits over the previous drug.
Unfortunately, the benefits of Pradaxa can also lead to risks. Unlike warfarin, you cannot test how well Pradaxa is working. Unfortunately, this may result in some patients receiving a larger dose of the medication than necessary, increasing their risk of serious bleeding events. In addition, the kidneys remove Pradaxa from the body, making it a dangerous drug for patients with decreased kidney function, which is common in older patients.
Another danger of Pradaxa is that there is no antidote. If a patient has a serious bleeding event from Pradaxa, the effects cannot be stopped — you must wait until they resolve spontaneously.
European officials had received 256 reports of fatal bleeding events in November 2011, just one year after the drug was approved in the US. European regulators recommended caution for doctors prescribing the drug to patients with reduced kidney function, especially elderly patients.
The FDA has said it is looking at reports associated with Pradaxa, but has not published numbers or types of reports received. It notes that reports for new drugs are typically higher than older ones, and says that the risk of bleeding was comparable between Pradaxa and warfarin during clinical trials.
The FDA also states that it currently believes Pradaxa’s benefits outweigh its risks.
Compensation for Pradaxa Injuries
Because Pradaxa is a new drug, we currently have no idea how many people have suffered or are likely to suffer serious bleeding events. To help make sure that all adverse events are counted, make sure that any bleeding event suffered by you or a loved one is reported to the FDA. You can also help make sure your injuries are counted by talking to a drug side effects attorney about Pradaxa. Getting compensation for your injuries not only helps you pay for serious consequences of this dangerous drug, but also helps us understand the human costs of this drug.
To learn more about your legal rights and options in the wake of a Pradaxa injury, please contact Colling Gilbert Wright & Carter in Orlando, Florida online or by phone at (855) 880-4741 for a free case evaluation.