Pradaxa
PRADAXA, also known as Dabigatran Etexilate Mesylate, is used to prevent stroke and harmful blood clots in people who have non-valvular atrial fibrillation. This medication can also be used to treat blood clots in the veins of legs, or lungs and to reduce the risk of them reoccurring.
PRADAXA is an anticoagulant that works by blocking thrombin, a clotting protein, from forming in your blood. PRADAXA is the only oral blood thinner, other than warfarin, with a specific reversal treatment to help your body clot normally again. Unlike the popular warfarin, PRADAXA requires no regular blood tests or dietary restrictions.
Side Effects
Bruising
Serious internal bleeding
Gastrointestinal bleeding
Unusual/painful swelling and discomfort
Prolonged bleeding from cuts or gums
Persistent/Frequent nosebleeds
Unusually heavy menstrual flow
Pink/dark or bloody urine
Coughing up blood
Severe headache
Dizziness/fainting
Unusual or persistent tiredness or weakness
Bloody/black/tarry stools
Vomiting
Abdominal pain
Severe heartburn
Death
Dangers and Lawsuits
Thousands of lawsuits have already been filed on behalf of patients who have suffered severe bleeding as a result of PRADAXA. Claimants further allege that the manufacturer of PRADAXA, Boehringer Ingelheim, made misleading claims regarding the effectiveness, safety and benefits of the drug.
In May 2014, the German drug maker Boehringer Ingelheim agreed to pay $650 million to settle an estimated 4,000 lawsuits.
In October 2015, the FDA approved changes to the Drug Safety labeling of PRADAXA. The Warnings and Precautions now read as follows:
Increased Risk of Thrombotic Events after Premature Discontinuation
If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate
Risk of Bleeding
Reversal of Anticoagulant Effect
-specific reversal agent (idarucizumab) for dabigatran is available when reversal of the anticoagulant effect of dabigatran is needed:
For emergency surgery/urgent procedures
In life-threatening or uncontrolled bleeding
Contact Us Today
If you or a loved one has taken PRADAXA and suffered an adverse side effect(s), it is important that you contact Gruber Law Offices immediately. To find out if we can help you, call the injury attorneys at Gruber Law Offices today.