Saturday, April 14, 2012

How Strong is Your Pradaxa Case?

If your doctor has prescribed the relatively new drug, Pradaxa, as an alternative to Warfarin, you may have been alarmed to hear of the potential issues with Pradaxa. Pradaxa was approved by the FDA in late 2010 after the manufacturer, Boehringer Ingelheim, presented the drug as a much better alternative to Warfarin, which had been used exclusively since the 1950’s as a treatment for the prevention of systemic embolisms and strokes. Pradaxa is used to treat patients with atrial fibrillation and works primarily by thinning the blood of the patient. While Pradaxa did appear to work slightly better than Warfarin, it has been shown to have serious side effects, some of them fatal.

How Does Pradaxa Work?

The primary issue with Pradaxa lies in how it works in the body. While both Pradaxa and Warfarin are used to prevent strokes in patients with atrial fibrillation, Warfarin works through the inhibition of Vitamin K in the body. Vitamin K is a clotting agent, and should Warfarin cause excessive bleeding in a patient, doses of Vitamin K can be administered to slow the bleeding. Pradaxa works by inhibiting an enzyme in the blood known as a thrombin. Thrombins are also responsible for controlling blood clotting, however at this time there is no known reversal agent to Pradaxa and should it cause excessive bleeding physicians have no way of slowing or stopping the bleeding. In the case of excessive bleeding among Pradaxa users they have no choice but to wait 12 to 24 hours until the drug has cleared their system, allowing the blood to clot as it should.

Unfortunately, some patients have bled so excessively they don’t have that amount of time. This has led to the death of several Pradaxa users, particularly those who are over the age of 75 or those with impaired renal function. The Pradaxa drug is also unique in how it gets into the patient’s system. The active ingredient in Pradaxa is actually contained in the outer shell of the drug while the encapsulated portion contains a core of tartaric acid. Scientists believe that this particular type of delivery system allows the drug to be mroe rapidly absorbed by increasing the acidity in the digestive tract. It is theorized that this delivery system can be responsible for major GI bleeds, and those who have experienced minor gastrointestinal symptoms may go on to have a excessive internal bleeding as a fairly minor ulceration turns into a serious or fatal hemorrhage.

Do I Have a Pradaxa Case?

If you have had adverse responses to the drug Pradaxa, your personal injury attorney will want to know whether those responses occurred prior to January, 2012, or after that date. This date is important because the FDA mandated changes in the warning labels of Pradaxa in January after receiving numerous adverse reports of serious side effects related to Pradaxa. It is believed that over 260 deaths have been directly tied to Pradaxa through uncontrollable bleeding incidents. Those who had an adverse response to Pradaxa prior to January of 2012 likely have a bit stronger case than those who had a negative incident after the FDA issued their warning. Those Pradaxa users who ended up with an extended hospital stay or died as a result of taking the drug whether through a gastrointestinal bleed, a hemorrhagic stroke or a trauma-induced atypical bleeding event, will likely hold a strong legal position against Boehringer Ingelheim.

Elderly patients with reduced renal functions are more likely to have experienced a serious side effect from Pradaxa since it builds up more quickly in the body. Any significant bleeding event can be responsible for a lack of blood flow to organs in the body which results in organ damage. While some organ damage can be reversible, others may not be. Pradaxa users have also experienced strokes and heart attacks as a result of taking the drug. Whatever damage you suffered as a result of taking Pradaxa, you have likely racked up significant medical expenses, lost time from work and suffered a substantial level of emotional distress, and may have a cause of action against the manufacturer of Pradaxa.

Author: Sullo & Sullo Attorneys

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