The side effects of the drug Pradaxa (dabigatran) have been a prominent concern for anticoagulant patients and prescribing physicians for the past several years.

The concern of uncontrollable internal bleeding complications has resulted in Boehringer Ingelheim facing major criticism for allegedly failing to warn consumers.

Like other anticoagulants, Pradaxa is typically prescribed to treat patients with atrial fibrillation and are at high risk for stroke. These medications work by inhibiting the body’s clotting ability, which increases overall circulation of the blood.

However, this also disables the body’s ability to recover from simple internal bleeding incidents, which can quickly turn fatal if not treated in time.

FDA Warns About Side Effects of the Drug Pradaxa

The side effects of the drug Pradaxa may include:

• Unusual Bruising or Bleeding
• Pink or Brown Urine
• Red or Black Tarry Stool
• Coughing up Blood
• Vomiting resembling Coffee Grounds
• Headaches, Dizziness or Lethargy
• Gums Bleeding Frequent Nose Bleeds
• Weakness and Swelling of the Arms, Hands, Feet, Ankles or Lower Legs
• Nausea
• Severe Heartburn
• Abdominal Pain

Patients who exhibit any of the side effects of the drug Pradaxa above should contact their doctor immediately, especially if coughing up blood or bleeding gums.

The FDA sent out a public safety warning regarding the side effects of the drug Pradaxa in December 2011, warning the public that internal bleeding was believed to be a problem.

The agency released this warning after reviewing post marketing problem reports with the drug, while also examining whether or not Pradaxa posed an unreasonable risk to consumers.

Overview of Pradaxa Bleeding Concern

Pradaxa first entered the market in 2010, and was the first medication to be released for anticoagulant treatment purposes since Warfarin in the 1960s. At the time of its release, Boehringer Ingelheim marketed the drug as safer and more efficient than Warfarin and that Pradaxa could be prescribed in a single dose.

This particular convenience made the medication very attractive to potential customers, as Warfarin prescriptions required patients to frequently see their doctors for dose adjustments. Even though this was inconvenient for many patients, many believe this requirement prevented a number of internal bleeding incidents.

In addition to the dose adjustments, Pradaxa did not have a readily available bleeding antidote in the case of internal bleeding incidents. While Warfarin patients had the option of implementing vitamin K in the case of internal bleeding incidents, other patients did not that option when contending with the side effects of the drug Pradaxa.

Boehringer Ingelheim is still facing legal action for allegedly failing to warn patients against the side effects of the drug Pradaxa. Potential claimants should contact a specialized lawyer, to determine eligibility for a Pradaxa lawsuit.