Pradaxa Poses Threat of Excessive Bleeding in Patients, over 500 Deaths Reported

 Posted on November 28, 2014 in Defective Drugs & Treatments

Pradaxa is a blood thinner, which was approved by the FDA in 2010, and prescribed to prevent blood clots in patients not suffering from a heart rhythm abnormality. Over a period of 11 months, an estimated 1.1 million prescriptions were written for the medication.

Since then, the FDA has issued multiple safety warnings about the potential of serious risks the use of Pradaxa carries for patients. Post-marketing reports have pointed to serious bleeding, some of which may lead to fatalities, occurring in patients taking the blood thinner.

The New York Times reported in 2012 that unlike warfarin, an older blood thinner, there is not an antidote to reverse the blood-thinning effects of Pradaxa and over 500 deaths had been linked to the drug. In the same month, the FDA issued an additional safety announcement stating that Pradaxa should not be used to prevent stroke or blood clot in patients with mechanical heart valves.

The FDA cited a report based on a clinical trial that was halted due to Pradaxa users being more susceptible to experiencing blood clots forming on the mechanical heart valves, strokes, and heart attacks.

Patients taking Pradaxa who exhibit any of the following symptoms are urged to contact their health providers right away:

• frequent nose bleeds;
• pink or brown urine;
• red, black, or tarry stools;
• unusual gum bleeding;
• coughing or vomiting blood; and
• heavier than usual menstrual bleeding.

Results from medical research can alter the original approval of a medication, causing a higher risk in some patients. The warnings issued by the FDA are made known to the public in order to protect patients.

When a drug manufacturer fails to properly test, label, or market its product, it can result in harm to a patient and the company should be held accountable. If you or a loved one experienced severe Pradaxa side effects, contact an Arlington Heights defective medical product attorney who can provide legal counsel about your case.