Pradaxa and Chantix Account for the Most Drug Complaints to the FDA

The October 2012 QuarterWatch report from the Institute for Safe Medication Practices details the number of drug complaints received by the FDA over the past four years. Prescription medication complaints issued to the FDA have risen 90 percent between 2008 and 2012. This increase amounts to an additional 27,290 cases per quarter1.

“All the increase was attributable to reports from drug manufacturers rather than cases submitted directly to the FDA,” the report claims1.

Prescription medications Pradaxa and Chantix are said to make up 37 percent of the 90 percent increase of serious adverse drug event reports1. The FDA has been investigating Pradaxa and its dangerous side effects since December 7, 2011. The FDA has received hundreds of reports of deaths among Pradaxa users for the year 2011, more than any other prescription medication in that same year.

Pradaxa is a blood-thinning drug meant to treat atrial fibrillation and reduce risk of stroke, pulmonary embolism and other blood-clotting conditions. Contrary to this, Pradaxa has been linked to complicated and often serious health problems such as internal bleeding, heart failure and death.

Other Pradaxa side effects may include:

  • Serious allergic reaction
  • Chest pain
  • Swelling of the face or tongue
  • Trouble breathing or wheezing
  • Feeling dizzy or faint
  • Indigestion
  • Stomach burning or pain
  • Nausea

Pradaxa has been on the market since October 2010 and has been the center of FDA investigations for reports of association with serious injuries. Learn more about Pradaxa side effects, FDA warnings, and issues associated with the blood-thinning drug today.

1 Institute for Safe Medication Practices. QuarterWatch: Monitoring FDA MedWatch Reports. Why Reports of Serious Adverse Drug Events Continue to Grow. October 3, 2012. PDF.

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