Pradaxa The Promising Drug with a Flaw

Pradaxa and what you should know

History is full of drugs that cause significant risks to those who take them. A vigorous screening process by the Food and Drug Administration (FDA) reduces the potential for a drug to do harm, but no process is perfect. Even drugs that pose significant benefits to patients may result in unwanted side effects. In rare cases, these side effects can be fatal. Such is the case with with this drug.

What is it?

Pradaxa is the trade name of dabigatran etexilate mesylate, an anticoagulant marketed by Boehringer Ingelheim. Pradaxa inhibits blood clotting by targeting thrombin. Thrombin is an enzyme that is responsible for the formation of fibrin, a protein necessary for blood clotting. Its anticoagulant functions make it a valuable tool for patients who are at high risk of blood clots, including patients with atrial fibrillation and patients who have recently undergone a hip or knee replacement surgery.

Pradaxa competes in the marketplace with another drug called warfarin. Warfarin uses a different mechanism to inhibit clotting; instead of inhibiting thrombin, it inhibits an enzyme that prevents vitamin K1 from being recycled. Reducing the amount of vitamin K1 in the blood inhibits coagulation. Replenishing vitamin K1 reverses the effects of warfarin. Patients who use this medicine must undergo periodic blood tests to ensure that they are receiving a dose that is effective and safe for their bodies and their dietary habits. In theory, Pradaxa requires no such monitoring, making it slightly more attractive.

What are the Risks?

Users who experience side effects often also experience severe bleeding. According to the Australian Therapeutic Goods Administration, gastrointestinal bleeding is the most common form of bleeding suffered by this drug. Elderly patients and patients with renal impairment are more likely to experience these effects. The bleeding risk also increases if patients take common pain relievers like aspirin and non-steroidal anti-inflammatory drugs.

Unlike warfarin, there is no way to reduce the clotting effect of the drug in the event of a negative reaction or an overdose. This has led to a large number of patients who suffered life threatening injuries. Between March 2008 and October 2011, the manufacturer confirmed that 260 patients who were receiving this drug died as a result of excessive bleeding. In 2011 alone, It was associated with 542 deaths and 3,239 other serious adverse events, including hemorrhages, strokes, and renal failure. The FDA has advised patients with mechanical heart valves to avoid taking it at all.

What to Do When Suffering Side Effects

Consult your physician immediately if you begin experiencing any side effects after taking this drug. Discuss your options for changing medications or dosage or for reducing your risk. Do not discontinue the medication without discussing it with your physician; abruptly stopping the use of any anticoagulant will increase the risk of stroke. If you experience uncontrolled bleeding, go to the nearest emergency room.

An attorney will also be helpful if you or a loved one has suffered such adverse effects from Pradaxa. By consulting an attorney experienced with lawsuits involving pharmaceutical companies, victims or their loved ones can discuss their rights under the law, identify the responsible parties for the injury, and discuss the feasibility of obtaining compensation by filing a civil action for negligence, malpractice, or wrongful death.
It is important for a person to research all medications and possible adverse side effects before they begin taking them. When injury or illness occurs from a drug, retaining a legal representative is important. Victims and their families should not be left with steep medical bills, the pain of enduring constant medical treatment, and the uncertainty of not knowing when the next adverse event might be their last.
Lisa Coleman writes to bring awareness to the drug Pradaxa and all the serious side effects that can be inflicted, including death.


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