FDA Announces Pradaxa Update, Fails to Tell Entire Story
After its most recent evaluation of the drug Pradaxa, the FDA has announced that users of Pradaxa did not find an increased risk of bleeding when compared to the use of the associated drug, warfarin. While this information is accurate, the FDA failed to state that the drug warfarin includes a reversal agent which would be essential if a bleeding emergency were to occur. Pradaxa, on the other hand, does not include an antidote which would be vital for anticlotting and the prevention of severe and possibly fatal bleeds.
To date, more than 100 lawsuits have been filed in regard to the adverse effects after use of the drug Pradaxa. If you or a loved one has suffered a serious bleed following the use of Pradaxa, Greg Coleman Law encourages for you to contact us as soon as possible for a Free Case Review to discuss your potential legal options.
Pradaxa is an anticoagulant that became available on the market in 2010. The oral medication is used to prevent strokes and blood clots in atrial fibrillation patients. Atrial fibrillation is a common type of abnormal heartbeat condition in elderly patients, in which the heart rhythm is fast and irregular. Individuals with atrial fibrillation have an increased risk for blood clots and strokes. Pradaxa belongs to a class of medications called direct thrombin inhibitors, which work by blocking a clotting protein in the patients blood. Since Pradaxa was approved by the Food and Drug Administration (FDA) in October 2010, patients have reported suffering from severe bleeding injuries that result in hospitalization and sometimes death.
Pradaxa Bleeding and Deaths
Numerous patients have reported suffering from internal bleeding after using Pradaxa. Boehringer Ingelheim, the German pharmaceutical company that makes Pradaxa, has reported 260 deaths linked to the drug. The pharmaceutical company claims that Pradaxa, also known by its chemical name dabigatran, is as safe as other blood thinning medications. Boehringer Ingelheim said that there is a bleeding risk when taking Pradaxa, just like there is when you take any other anticoagulant. In December 2011, the FDA announced that they were reviewing reports of Pradaxa bleeding injuries.
Other countries have also expressed concerns about the bleeding risks associated with Pradaxa. Japanese regulators told Boehringer Ingelheim to issue a strong warning to physicians about potentially fatal bleeding due to Pradaxa use. In 2011, European regulators warned the public to have their kidneys checked before using Pradaxa. Patients with weak kidneys are susceptible to internal bleeding.
Pradaxa Side Effects
Like other blood thinning medications, Pradaxa use comes with the risk of internal bleeding. Pradaxa patients should contact their doctors immediately if they experience any of the following symptoms:
- Unusual bruising or bleeding
- Coughing up blood
- Pink or brown urine
- Red or black tarry stools
- Joint pain or swelling
- Bleeding from the gums
- Frequent nosebleeds
- Heavy menstrual bleeding
- Swelling of the hands, arms, feet, ankles and legs
- Vomiting blood or a material that looks like coffee grounds
Doctors are worried about Pradaxa bleeding events; unlike other anticoagulants, there is no antidote to stop the bleeding.
Individuals who take Pradaxa are also at an increased risk for heart attacks. Research has shown that atrial fibrillation patients that use Pradaxa have a 38 percent higher chance of having heart attacks than patients who take other anti-coagulants.
Tennessee Pradaxa Attorneys
Greg Coleman Law believes that pharmaceutical companies should be held responsible for any injuries that their dangerous drugs may cause. If you or a loved one has sustained a Pradaxa injury, you may be able to seek compensation for medical bills, lost wages, pain and suffering. Contact the Tennessee Pradaxa attorneys at Greg Coleman Law to discuss your legal options. To receive a free case review, fill out the online contact form on this page.