The pharmaceutical company that created Pradaxa allegedly hid a serious potential risk of the medication-Pradaxa cerebral hemorrhaging and other internal bleeding, according to some patients.

Pradaxa, known generically as dabigatran, was developed by Boehringer Ingelheim Pharmaceuticals and hit the U.S. commercial market in October 2010 following its approval by the U.S. Food and Drug Administration (FDA).

It, like others of its class of direct thrombin inhibitors, was promoted as superior to Coumadin, the brand name for warfarin—an anticoagulant medication used successfully for several decades. Many patients reported Pradaxa cerebral hemorrhaging, however.

Pradaxa was said to need only once per day dosing and fewer, if any, trips to the laboratory to monitor the blood while ingestion. The drug’s promotion also emphasized that the patient need not change their diet during treatment.

What Dietary Modifications Does Coumadin Require?

Warfarin requires dietary modifications to avoid decreasing or increasing its thinning action on the blood.

According to the Mayo Clinic, takers of Coumadin must avoid large amounts of green vegetables high in vitamin K such as kale, spinach, brussels sprouts, and collard greens. They also need to avoid a large intake of alcohol and cranberry juice which can further thin the blood. There are also several herbal and mineral supplements that can interfere with its effectiveness, including ginkgo biloba, coenzyme Q10, ginseng, and St. John’s Wort.

A Drug Commercially Released without an Antidote

The major reason green vegetables high in vitamin K needed to be avoided while taking Coumadin was that this vitamin counteracts the action of the blood-thinner and is a well-known antidote.

If a patient had an episode of internal bleeding, physicians knew that a rapid infusion of this vitamin would bring the bleeding under control.

Unfortunately, instances of internal bleeding, such as Pradaxa cerebral hemorrhaging, had no such antidote for its first five years on the market. It wasn’t available until the FDA granted accelerated approval to Praxbind, in October 2015.

For those that experienced Pradaxa cerebral hemorrhaging leading to stroke or gastrointestinal and other uncontrolled bleeding leading to injury or even wrongful death, this antidote came into the picture a little late.

There were numerous injuries reported with the use of this drug. According to the FDA adverse medical event database, there were over 300 reports of serious health consequences including Pradaxa cerebral hemorrhaging just in the first quarter of the drug’s commercial availability.

By Pradaxa’s first anniversary of FDA approval, the drug oversight agency was issuing its first warning of the possibility of serious and uncontrolled bleeding associated with its use. There were supposedly 300 deaths associated at that time.

There have been a great number of lawsuits filed against Boehringer Ingelheim for this delay in providing an antidote and for their alleged knowledge of these serious life-threatening side effects such as Pradaxa cerebral hemorrhaging. Current class action lawsuit investigations are looking for people who have experienced injury from this medication.

Symptoms of internal bleeding can seem relatively benign such as discolored excrement and urine or getting nosebleeds several times a week. If you’ve experienced these or other indicators of internal bleeding, fill out our form for a free initial consultation with one of our expert medical products liability attorneys.