A Chicago man is suing the manufacturer of the blood thinner Pradaxa claiming the drug caused him to develop a severe hematoma for which he needed to be hospitalized. The bleeding condition required the man to under go surgery and to have a blood transfusion.
Pradaxa is a blood thinner that was approved by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with a common type of heart rhythm abnormality known as atrial fibrillation. Pradaxa became the first anticoagulant approved for that indication since warfarin, which hit the market more than 50 years ago.
Pradaxa showed promising results in stroke prevention. And, unlike warfarin, it does not require patients to follow specific diets and be regularly monitored for potential bleeding events. The drug’s maker, Boehringer Ingelheim, launched a massive marketing campaign, which paid off with sales topping $1 billion in its first year.
Also in its first year, Pradaxa was associated with more deaths than any other drug monitored by the FDA.
Pradaxa may do a better job than warfarin of preventing strokes, but because it is so new to the market, there is no antidote to reverse the effects in the event of a bleed as there is with warfarin. If serious bleeding occurs, it may be irreversible, permanently disabling, and life-threatening.
The FDA is currently conducting a safety review of Pradaxa’s bleeding risk. Canada’s drug regulator, Health Canada, is also investigating cases of heart attack associated with the drug.
Source: Opposing Views