What is the status of the FDA review of Pradaxa?

 The law firm of Miller and Zois reports:

 “In early 2011, the FDA received over 500 reports of Pradaxa bleeding injuries—this within months of the drug’s release.  Users of Pradaxa may suffer from internal bleeding, hemorrhaging, or other problems.  By December of 2011, the FDA announced a Pradaxa safety review, the first step toward determining whether a Pradaxa recall is necessary. 

The National Institutes of Health reports 932 serious events between January 2011 and March 2011:

  • 120 deaths
  • 25 permanent disabilities because of the drug
  • 543 hospitalizations
  • 505 incidents of hemorrhage or internal bleeding

Warfarin, the drug that Pradaxa was intended to replace, may also cause internal bleeding.  However, those problems can be countered by administering vitamin K (because Warfarin interferes with vitamin K, which is essential to creating blood clots).  For Pradaxa patients, there is no similarly simple solution for excessive internal bleeding. 

Additionally, researchers are investigating whether the drug is effective.   The FDA is concerned that the drug may have too little effect, which may cause deep vein thrombosis and pulmonary embolism.

Though the investigation is continuing, there may have been over 500 Pradaxa-related deaths in the first year of use.  Experts are concerned that the initial clinical trials were faulty, which may have allowed this defective drug to be rushed to the market.  Boehringer Ingelheim conducted a study called the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, and gave that information to the FDA to prove that it was ripe for release to the market. “ (emphasis supplied)

       The same website states that Pradaxa was approved in August in 2011.

The FDA  states:

” Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial (18,000 patients) comparing Pradaxa (dabigatran etexilate mesylate) and warfarin, major bleeding events occurred at similar rates with the two drugs. At present, the FDA is evaluating the post-marketing reports of serious bleeding in patients taking Pradaxa submitted to the Adverse Events Reporting System (AERS) database. While serious, even fatal events have been reported, the FDA is analyzing the events to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa”. (emphasisi supplied.)

        It appears we have just passed the first year anniversary of a pharmaceutical of increasing popularity.

 Question:  When will the FDA complete its review of Pradaxa?



1 comment. Leave a Reply

  1. CRE

    Based upon subsequent research by CRE, we find:

    (1) While there is no antidote for Pradaxa, its effects are short-lived that is why it is prescribed two times a day.

    (2) It is too early to determine whether the recent reports associated with bleeding from Pradaxa are a result of more timely reporting of adverse effects of a new drug or a statistically significant increase. CRE expects an answer in the near future as a result of ongoing epidemiological studies.

    (3) CRE can not find one scintilla of evidence that FDA is considering a recall.

    (4) Randomized clinical trials show similar bleeding rates between Warfarin and Pradaxa.

    (5) In addition CRE could not locate one person with a medical background—as opposed to a legal background— who concluded that the RE-LY study was deficient or that Pradaxa was not effective.

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