The FDA is evaluating reports of serious bleeding events in patients taking the blood-thinning drug, and is issuing specific warnings to patients and physicians who are currently taking, or may be prescribed, this popular drug.

Frenkel & Frenkel, a Dallas law firm, recently learned of potential side effects that have led the Food and Drug Administration (FDA) to issue Pradaxa warnings.  The agency is evaluating reports of serious bleeding events in patients taking the blood-thinning drug, and is issuing specific warnings to patients and physicians who are currently taking, or may be prescribed, this popular drug. What is Pradaxa? Pradaxa[i], or dabigatran, prevents blood clots from forming due to irregular heartbeats, known as atrial fibrillation (AF), which reduces the risk of stroke in many patients.  The drug is an anticoagulant that blocks thrombin, a clotting protein, from forming in the blood.  Patients normally take the drug once per day to prevent clots after surgery, and twice per day to prevent clots from AF.  Because the drug reduces the clotting effect of blood, there is an increased bleeding risk, but the recent Pradaxa warnings indicate that the risk may be higher with Pradaxa than with other drugs. FDA Warning[ii] Although the current Pradaxa warnings found on the drug label contains wording that warns of an increased bleeding risk, and that the bleeding could be potentially fatal, recent reports indicate that bleeding in patients taking Pradaxa may be occurring more frequently than with other drugs.  Because the FDA is just beginning to investigate the reports, the agency issued Pradaxa warnings to patients and doctors about precautions when taking the drug. Precautions Suggested A few of the precautions[iii] suggested by the FDA in the Predaxa warnings include

• Do not take Pradaxa if you have a bleeding disorder, intestinal or stomach ulcers or bleeding, bleeding in the brain, an aneurysm, kidney disease, renal failure or any allergies to foods, dyes or preservatives.
• Inform your physician if you have upcoming surgery, are pregnant, may become pregnant, or are breastfeeding.

In addition, patients taking Pradaxa should contact their doctor immediately if they:

• Begin to bruise easily.
• Find that cuts and scrapes are slow to stop bleeding.
• Experience black, tarry stools, bright red blood in the stool, or vomiting of blood, as these are signs of gastrointestinal bleeding;
• Vision or speech changes, weakness in an arm or leg, or severe headache. as these are signs of bleeding in the brain.

If you have more questions about the FDA Pradaxa warnings, contact us at Frenkel & Frenkel at 214-333-3333, 817-222-2222, or toll free at 800-834-0000.