Pradaxa, a pharmaceutical anticoagulant drug, was approved by the federal Food and Drug Administration (FDA) in October 2010. Pradaxa has since been linked to problems with internal bleeding.

Pradaxa internal bleeding symptoms can be mild to severe, but if left unchecked, Pradaxa internal bleeding can lead to organ system shutdown and even death.

Pradaxa was approved for the market in October 2010 by the U.S. Food and Drug Administration (FDA). Pradaxa is prescribed as a stroke preventative for patients with non-valvular atrial fibrillation, and a pulmonary and deep vein thrombosis preventative for patients undergoing total hip and knee replacement.

Pradaxa reportedly had 3,781 cases of adverse medical events reported cumulatively between the FDA, health professionals, databases, and the manufacturers in 2011 – its first year on the market.

Included in that total number of adverse events are 542 near-fatalities. A lot of those incidents were because of Pradaxa internal bleeding symptoms that were not caught in time.

A List of Pradaxa Internal Bleeding Symptoms

Pradaxa internal bleeding symptoms need to be recognized to get expert medical care as soon as possible. Here is a list of primary signs and symptoms to be on the lookout for:

• Bruises that seem to randomly occur without initiating injury. They may get larger without additional provocation.
• Gums bleeding excessively with minor irritation such as flossing.
• Vomit containing what appears to coffee grounds or obvious blood.
• Passing brown-tinged or pink-tinged urine.
• Bowel movements with black stools.
• Bleeding from the nose often.
• Heavy menstrual flow that is highly unusual for patient.
• Other bleeding that seemingly cannot be brought under control.
• Coughing up blood or blood clots.

Pradaxa Internal Bleeding Symptoms Can Now Be Treated

After Pradaxa’s initial approval, the drug was aggressively marketed by the manufacturer, Boehringer Ingelheim, to be superior to warfarin, an anticoagulant with a lengthy history of use.

The company based this marketing campaign on twin factors that set it apart – the fact that there was no need for regular blood monitoring to check dosage level, and the fact that there was no need to curtail diet while on the medication.

What also set Pradaxa apart from warfarin at the time of its initial approval was a total lack of remedy should uncontrolled bleeding occur. With warfarin, the blood-thinning effects of the medication could be reversed by giving the patient a significant dosage of vitamin K1.

In fact, according to www.pradaxa.com, the dietary restrictions necessary with warfarin included staying away from green leafy vegetables and some vegetable oils with vitamin K1 that would render the medication ineffective.

Boehringer Ingelheim has since created a remedy for Pradaxa known as Praxbind. Praxbind was not approved for the market until five years after the initial approval by the FDA. But in the interim, thousands of Pradaxa patients suffered from significant internal bleeding without the benefit of an antidote.

If you or a loved one took Pradaxa and suffered Pradaxa internal bleeding symptoms, you may qualify to seek compensation from the manufacturers. Product liability lawyers are available for a free consultation.