Reports of Pradaxa adverse side effects include episodes of serious or fatal internal bleeding of the brain and gastrointestinal system.

Pradaxa (dabigatran) is an anticoagulant that was approved by the FDA in 2010. Pradaxa belongs to a class of drugs known as Direct Thrombin Inhibitors, a relatively new class of blood thinners that works by blocking thrombin, the body’s main blood clotting protein.

The drug reduces the chances of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function improperly. Patients with atrial fibrillation may have an increased risk of stroke that is five times that of the general population. Even though atrial fibrillation by itself is not a life-threatening condition, the strokes that occur as a result of atrial fibrillation are statistically found to be more severe, with a greater incidence of death or disability.

Pradaxa’s side effects include bruising, minor bleeding, indigestion and heartburn. Gastrointestinal or brain bleeding can occur when too much thrombin is blocked.

Pradaxa Adverse Side Effects Include Uncontrollable Bleeding

Pradaxa uncontrollable bleeding was reportedly fatal for 260 patients by November 2010. Another 540 patients using Pradaxa died in 2011. Ususpecting patients may not have known that severe or fatal bleeding could be a side effect because, according to patient advocates, drug manufacturer Boehringer Ingelheim did not adequately disclose that Pradaxa-induced bleeding was irreversible and that no reversal agent existed at the time.

The latter is important because Pradaxa worked to woo away patients who had been taking Coumadin (warfarin), which had been a relatively safe blood thinner prescribed to patients for more than 50 years. Warfarin users need their blood tested periodically to make sure the dose is therapeutic. If the dose is too high, the patient could experience uncontrollable bleeding; too low a dose would leave the patient open to blood clots.

Pradaxa’s big selling point was that it was a “one dose fits all” medication and no blood monitoring was needed to render it safe and effective. In contrast to that claim, Pradaxa adverse side effects lawsuits allege the drug ought to be monitored in order to be appropriately dosed for each individual patient. Critics say that one dose of Pradaxa might keep one patient from developing blood clots, but the same dose might cause a different patient to suffer Pradaxa adverse side effects.

Drug Maker Delayed Introduction of Antidote

While touting Pradaxa’s alleged superiority over warfarin, Boehringer Ingelheim neglected to mention that no antidote existed for Pradaxa during the early years it was on the market.

In the event of surgery or an accident, warfarin users are given an intravenous dose of vitamin K, which counteracts warfarin’s anti-coagulating effects. This antidote is well-known in emergency rooms around the country and has saved lives.

When Pradaxa was introduced, no antidote was known at the time. Boehringer Ingelheim finally sought approval for Pradaxa antidote Praxbind in February 2015. The drug company allegedly had the formula for Praxbind for years, but no explanation has come forth regarding the delay in the antidote’s introduction.

If you or someone you love has suffered Pradaxa adverse side effects, you could benefit by speaking with an attorney regarding your legal options for compensation.