The U.S. Food and Drug Administration (FDA) announced that it will be looking into post-marketing reports of Pradaxa® internal bleeding events. Pradaxa® (dabigatran etexilate) was first released onto the U.S. market in October 2010 as an anticoagulant, designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF). By August 2011, the drug had been administered to over 370,000 patients in the U.S., according to Pradaxa®'s manufacturer, Boehringer Ingleheim.
In the first quarter of its use in the U.S., Pradaxa® was the subject of hundreds of reports of serious adverse events, including internal bleeding and internal bleeding deaths.
Pradaxa® Linked to Internal Bleeding
Pradaxa®'s link to internal bleeding has resulted in intense scrutiny. The FDA initiated an investigation into the internal bleeding deaths associated with the anticoagulant in late 2011. In a safety announcement sent on Dec. 7, 2011, the FDA said it is "working to determine whether the reports of bleeding in patients taking Pradaxa® (dabigatran) are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa®."
The agency noted that a serious bleeding event that may result in death is a "well-recognized complication of all anticoagulant therapies."
Symptoms of Internal Bleeding
Everyone who is treated with Pradaxa®/dabigatran etexilate or another anticoagulant should be well informed about the signs and symptoms of internal bleeding, which include:
- abdominal pain and/or swelling
- chest pain
- external bleeding through a natural opening, such as vaginal bleeding (heavier than normal or after menopause)
- blood in the stools or urine
- blood in the vomit (red, or brown like coffee grounds)
These symptoms can get worse as the internal bleeding continues.
Internal Bleeding and Death
Internal bleeding can result in death. If you've been treated with Pradaxa® (dabigatran) or another anticoagulant (e.g., warfarin) and you're experiencing the above symptoms, call 911 or an emergency facility. It's not wise to "wait it out" or hope that the symptoms are temporary. The link between Pradaxa® and internal bleeding deaths should not be overlooked.
Contact a Pradaxa® Injury Attorney
If you'd like to know more about Pradaxa®'s internal bleeding risk, contact a Pradaxa® injury attorney for a free consultation.