Pradaxa is the brand name of a medication known as dabigatran. It is a prescription drug that causes thinning of the blood and is often prescribed to prevent blood clots in patients with atrial fibrillation caused by a heart valve malfunction.
Because blood clots can be instantly fatal if they block blood flow in the heart, lungs, or brain, many physicians prescribe blood thinners to patients with an increased risk of blood clots due to atrial fibrillation or other conditions. Blood thinners, however, carry their own risks, including a risk of uncontrolled bleeding. Such an increased risk has been reported by patients taking Pradaxa. Any patient that has suffered injury as the result of Pradaxa-use or the family of a patient who has died as the result of a side effect may be able to hold the pharmaceutical company responsible for the harm it caused. Learn more about your rights and options by calling the Pradaxa lawyers of Farah & Farah at 877-245-6707.
Pradaxa Side Effects
Serious side effects that have been reported with Pradaxa-use include heart attacks and internal bleeding. Either of these conditions can prove fatal.
Pradaxa was approved for use in the United States in 2011. The approval was based on a study of 18,000 patients that compared the effects of Pradaxa to those of warfarin, a blood-thinning medication that is still in common use. At the time, the studies estimated that the risks of internal bleeding and other conditions were lower in Pradaxa patients than in patients who used warfarin.
One risk Pradaxa patients face in particular, however, is that there is currently no antidote to Pradaxa. Patients who experience uncontrolled bleeding on other blood-thinning medications can be treated with other medications to slow the bleeding and encourage blood clotting; however, these options are not available for Pradaxa patients because of the unique way in which Pradaxa works. As a result, internal bleeding triggered by Pradaxa is often untreatable, increasing the risk that a severe bleed will result in death.
Risk factors for internal bleeding on Pradaxa include age, with elderly persons having a higher risk than younger ones, and kidney function, with patients with compromised kidneys having a higher risk than patients with healthy kidneys. However, no patient who uses Pradaxa can completely escape the risks the drug poses.
Pradaxa’s FDA Safety Warning
In December 2011, the U.S. Food and Drug Administration (FDA) issued a Safety Communication regarding the use of Pradaxa. The FDA’s warning noted that, although the agency had been aware of the elevated risk of internal bleeding faced by Pradaxa users, post-market reports indicated that the risk was higher than the FDA had estimated when it approved Pradaxa for sale in the United States.
Specifically, the FDA reported that between October 2010 and August 2011, nearly 2,000 Pradaxa users reported gastrointestinal or vascular hemorrhage. Both conditions are types of internal bleeding that can cause serious injury or death. During this time period, the FDA estimated there were 371,000 Pradaxa users in the United States.
Since the safety warning was issued, Pradaxa has carried stronger warnings about the risks of internal bleeding on its packaging. However, the medication has not been recalled.
Pradaxa Attorneys Investigating Drug Injury Lawsuits
Beginning in 2012, many lawsuits relating to Pradaxa-use arose throughout the United States. Most are being pursued in federal court under the complex set of rules that govern multidistrict litigation, or MDL. To find out about the legal options available for your situation, contact the personal injury attorneys at Farah & Farah at 877-245-6707 for a consultation today.