Blood Thinner Pradaxa Linked to Serious Bleeding Events

On December 7, 2011, the Food & Drug Administration (FDA) issued a safety communication regarding the recently approved blood thinner Pradaxa. Patients taking Pradaxa have reported serious bleeding events while on the drug.

Pradaxa, which is manufactured by Boehringer Ingelheim, was approved in October 2010 to reduce the risk of stroke and blood clots in patients who have non-valvular atrial fibrillation. Less than one year after being approved, Pradaxa had been prescribed to an estimated 371,000 patients, and more than 1.1 million prescriptions had been written for the drug.

Serious Bleeding Events
In November 2011, 50 cases of fatal bleeding associated with Praxada had been reported worldwide. Boehringer Ingeleheim later acknowledged that as many as 260 deaths had occurred from the severe bleeding.

The FDA is currently conducting studies to determine whether the risk of bleeding for patients on Pradaxa is more serious than for patients on traditional blood thinning medications like Warfarin. While all blood thinning drugs carry the risk of bleeding, experts worry that Pradaxa may cause more serious and life-threatening bleeding events.

Pradaxa’s label already contains a warning that significant and sometimes fatal bleeding events can occur in patients taking the drug. Additionally, a new study conducted by the Cleveland Clinic shows that patients taking Pradaxa have a 33 percent increased risk of experiencing a heart attack than patients taking Warfarin.

The FDA has issued a statement regarding Pradaxa, saying “At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.”

Both Japan and Australia have issued safety warnings linking the drug to serious bleeding events. While the FDA has not issued any additional safety warnings, the agency has said that the drug breaks down quickly when removed from its original container.

Signs & Symptoms of Serious Bleeding Events
If you experience any of the following symptoms, the FDA recommends that you contact your health care provider immediately:

Persistent nose bleeding
Severe or uncontrollable bleeding
Unusual gum bleeding
Heavier than normal menstrual bleeding
Vomiting blood
Coughing up blood
Bruising
Red or black stool
Pink or brown urine

If you or a loved one has experienced a serious bleeding event while taking Pradaxa, you may have a claim against the manufacturer. Call experienced dangerous drug attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 to learn more about your legal rights.

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