In a latest report issued by The New York Times and Forbes the federal agency FDA is accused of not assessing the post marketing surveillance study effectively and that the statement that the rate of bleeding events linked to Pradaxa are no higher than those associated with Warfarin is flawed and needs to be re-evaluated and reconsidered. Pradaxa is a blood thinning and anticoagulant drug widely used across the United States to treat occurrence of thrombosis and embolus in the blood that are some of the main reasons of heart attack. However in the light of Pradaxa side effects that drug was under the scrutiny of FDA and other federal agencies.

The thrombosis and embolus are generally produced in the muscles of thigh and legs and once they escape these areas they enter into the blood circulatory system of heart which ultimately leads to myocardial infarction and other complications like chest pain and heart attacks. The drug is widely being used as the alternative to the drug Warfarin.

FDA had issued a report that stated that the rate of bleeding events linked to Pradaxa is no higher than those associated with Warfarin. The report was based on a number of post-marketing surveillance studies that reported bleeding after having used this drug by users.

However the New York Times and Forbes have said that the FDA failed to mention serious safety issues associated with the drug as the report didn’t reveal that the blood thinner Pradaxa lacks an antidote that has raised a number of health concerns to people and agencies. Unlike warfarin, there is no way to stop the bleeding in a Pradaxa patient.

What is pradaxa?

The drug Pradaxa manufactured by the pharmaceutical giant Boehringer Ingelheim is a blood thinner or commonly called as anticoagulant from the class of the direct thrombin inhibitors used for various clinical indications. The drug was widely recognized and considered as an effective alternative to Warfarin.

Some Side Effects of Pradaxa

  • Continuous and non-stop bleeding
  • Passing black or tarry stools
  • Passing blood in urine or stool
  • Weakness
  • Appearance of red or purple spots under the skin
  • Unusual bleeding through various parts of the body like mouth, nose, vagina
  • Vomiting and coughing up blood
  • Pain in bones and joints
  • Heavy menstrual bleeding

Some other side effects of Pradaxa are:

  • Upset stomach
  • Indigestion
  • Continuous pain in the abdomen or stomach region
  • Heartburn
  • Itching of skin
  • Diarrhea
  • Appearance of rash on the skin

The blood thinner Pradaxa was approved by the Food and Drug Administration in the year of 2010 under an expedited review process. However, the latest happenings are posing many questions to such kinds of expedited reviews and various stakeholders are of the opinion that this could be a primary example of how this type of approval can expose patients to serious safety risks from unsafe medications. The incidence has also raised concerns about the way the agency is evaluating the performance of a drug after they are being marketed and stake holders are of the opinion that post-marketing surveillance mechanism needs to be strengthened and empowered.