Pradaxa is the name under which one of the newest anticoagulants is marketed in the U.S. The drug has as active ingredient dabigatran etexilat and it is an anticoagulant from the thrombin inhibitor class. It works by inhibiting one of the enzymes responsible for the blood clotting process. When the drug reaches the blood stream it attaches itself to the thrombin, affecting its capacity of clotting.
When in 2010 the Food and Drug Administration approved Pradaxa it was designated to be a substitute for warfarin, because it needs less medical supervision during treatment than the older generation anticoagulants. Due to proper commercials Pradaxa began to be largely used on the U.S. market. In the year following its approval the drug was prescribed to around 1 million patients.
Pradaxa is mainly recommended for individuals suffering from atrial fibrillation one of the most common types of heart rhythm abnormalities. The condition is characterized by the fact that the two upper chambers of the heart do not work simultaneously, allowing the blood to poll in one of the chambers. When that happens, the blood can clot. Blood clots travel through the body; they can reach the brain and block an artery. If that occurs, patients will suffer a stroke. That is why it is essential for atrial fibrillation patients to take some kind of anticoagulants.
Pradaxa can only be taken with medical prescription. Before beginning a treatment patients should inform their doctors if they suffer from bleeding problems, from kidney problems, if they are allergic to any of the drug’s components and if they are pregnant or breastfeeding. If any of those is the case, the medication is not recommended. After Pradaxa has been prescribed it should be taken daily, strictly respecting the dosage, for a longer period of time. However the medication can still affect patients.
Like all prescription drugs Pradaxa also has a series of side effects, some of them severe. The most severe side effects are related to internal bleeding. The product’s label warns patients about the risks and advises them to ask for medical help in case they occur. Medical support will be needed if a patient experiences the following symptoms: frequent bleeding from the gums, nose bleeding, unusual bruises, pink color urine, vomiting blood or coughing up blood.
What the manufacturing company doesn’t say is how frequent these injuries will be. Besides that, uncontrolled internal bleeding can easily lead to death. Statics show that within one year there were more than 250 deaths reported worldwide related to Pradaxa use. Affected patients or families of the deceased ones decided to file Pradaxa lawsuits. The FDA also reacted to the alarming reports and started an official search regarding the drug’s efficiency and safety. However, as long as the search is ongoing new patients will continue to be prescribed with the medication. So what should they do in case of injury?
According to the U.S. law manufacturing companies have the responsibility to release on the market relatively safe products or if that is not possible to inform their clients about the risks. As probably patients already know, all anticoagulants have side effects but they still need them to prevent other life threatening conditions. The term “relatively safe” can of course be interpreted in many different ways. However prescriptions drugs are considered to be safe and adequate for use as long as the benefits overweight the risks. That means that even life threatening side effects can be acceptable as long as patients are properly informed about them and severe injuries remain isolated incidents. So the question is how frequent internal bleeding reports have to be in order for Pradaxa to be considered an unsafe drug and a class action lawsuit could be filed.
The FDA’s official report will establish how safe Pradaxa is compared to other anticoagulants. So far individual clinical studies have revealed that although the medication is efficient in preventing stroke, patients treated with Pradaxa have 30% higher chances of suffering a heart attack than people treated with warfarin. This argument can be used in favor of plaintiffs in case of a product liability lawsuit. Besides that injured patients will have to prove that they used the drug respecting the medical prescription, that they suffered severe injuries due to it and that those injuries resulted in financial losses. If they can do so, they have a valid legal claim for a Pradaxa lawsuit. So if any injured individual considers he could qualify for financial compensation, consulting a personal injury lawyer is the right way to start his legal action.