Synopsis of Prescription Drug Litigation
Oct. 20, 2010 -The FDA has approved Pradaxa, a new drug to prevent blood clots in patients with atrial fibrillation. Pradaxa's generic name is dabigatran etexilate. It is made by Boehringer Ingelheim Pharmaceuticals. Pradaxa can have adverse effects, including life-threatening bleeding. Other side effects may include gastrointestinal symptoms (including dyspepsia, an unpleasant feeling in the stomach), stomach pain, nausea, heartburn, and bloating.
For more information about Pradaxa lawsuits contact us online or call 888-732-7047 for your free case evaluation.
Pradaxa® (dabigatran etexilate): Manufactured by Boehringer Ingelheim (BI) and approved by the FDA in 2010. Pradaxa belongs to a class of drugs known as blood thinners. The medication is used to reduce the risk of blood clots and stroke in patients with a heart problem known as atrial fibrillation.
Atrial fibrillation is a disorder that occurs when the hearts two upper chambers quiver as opposed to beating correctly. This condition increases the risk of serious health problems such as blood clots and stroke.
Why is this medication prescribed?:
Dabigatran is used to help prevent strokes or serious blood clots in people who have atrial fibrillation (condition in the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes). Dabigatran is in a class of anticoagulant ('blood thinner') medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
FDA indications: PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
What you should know before taking Pradaxa:
Patients should be aware that once a bottle of dabigatran is opened, the medication is considered to be expired after only thirty days. This unusually short period exists because the drug can be affected by humidity.
What special precautions should I follow?:
Before taking dabigatran,
- tell your doctor and pharmacist if you are allergic to dabigatran, any other medications, or any of the ingredients in dabigatran capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other anticoagulants ('blood thinners') such as warfarin (Coumadin), aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve), clopidogrel (Plavix), heparin, prasugrel (Effient), and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have recently noticed any unusual bruising or bleeding. Your doctor may tell you not to take dabigatran.
- tell your doctor if you are 75 years of age or older and if you have or have ever had a bleeding problem, bleeding or an ulcer in your stomach or intestine, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dabigatran, call your doctor. Taking dabigatran may increase the risk that you will experience severe bleeding during labor and delivery.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dabigatran.
What storage conditions are needed for this medication?:
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture. Throw away any medication that is outdated or no longer needed, and throw away any medication that is left in the container 30 days after you opened it. Talk to your pharmacist about the proper disposal of your medication.
Lawsuits: Currently, there have been several deaths and injuries associated with Pradaxa. Lawsuits are starting to mount in the U.S. although no class-action suits have been filed to date.
When to call the Venardi Law Firm: If you or a loved one has experienced serious adverse side effects from Pradaxa or know of an individual that has died due to major bleeding, you should call the Venardi Law Firm for a free consultation. We will be able to evaluate the strength of your case and take it on contingency.
Contraindications of Pradaxa include:
Pradaxa is contraindicated in patients with active pathological bleeding and patients with a known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to Pradaxa.
Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.
Risk factors for bleeding include: Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).
