Wiggles
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Wiggles, May 8,  2018  9:37am EST

Andexxa Approval

I was excited to hear about the approval of Andexxa, the new reversal agent for those of us on Xarelto, etc.  However, I don't think we should be overly confident that this drug is really "safe."  I fear that the FDA has rushed this through and it really is not thoroughly tested which has happened with other drugs rushed on the market in the past for which we've (and I have been!) been guinea pigs.  I only hope I don't ever need it.  I wonder if we Afib people would be considered "healthy" people such as who they talk about that the drug was tested on??  I took this quote from a website:

"Andexxa was approved under the FDA's accelerated approval pathway based on effects in healthy volunteers, and continued approval may be contingent on postmarketing studies to demonstrate an improvement in hemostasis in patients. A clinical trial comparing this agent or usual care is scheduled to start in 2019 and to be reported in 2023.

Andexxa was approved with a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, and sudden death. Treatment with the agent has been associated with serious and life-threatening adverse events, including arterial and venous thromboembolic events, cardiac arrest, sudden deaths, and ischemic events, such as myocardial infarction and ischemic stroke.

The most common adverse reactions in at least 5% of patients receiving Andexxa were urinary tract infections and pneumonia."

3 Replies
  • mdlagas
    mdlagas, May 9,  2018  8:16am EST

    Pharmacuetical companies are required to state any conditions that may have occurred to patients while taking a drug as possible side effects.  In many cases these "side effects" are completely unrelated to the condition the drug is treating and have absolutely nothing to do with the drug.  For example, at the extreme of this, someone taking a medication to treat a rash on their arm could die as the result of a heart attack brought about by excessive excercise and the medication they were taking would have to say death is a possible side effect.  As far as that goes, death is a possible side effect of every medication that you take if it is abused or just not taken as directed.

    As far as the allergy warnings are concerned you would be surprised how many times a prescription is written for a drug that is listed as an allergy in your medical history.  It doesn't happen nearly as much now as 20-30 years ago but I still occasionally will have a prescription written for penicillin or a penicillin derivative even though it has been in my medical history for 40+ years that I am allergic to it.

  • Jeanamo815
    Jeanamo815, May 8,  2018  5:14pm EST

    Oh, Roy...you took the words right out of my mouth about all those TV commercials for drugs that say "if you are allergic to it, don't take it".   How can  you know if you are allergic to it if you don't take it?!!!  What a dumb statement.   I think the pharmaceutical companies must cover every possible adverse effect in their commercials to protect themselves against future lawsuits....some even say "possible death".....now that is scary!  It sets off the "alarm button" in our brain to hear things like that.

     I had a major bleed at one time while taking Pradaxa and it was before there was a reversal agent.  It was also bad timing as it occured right after I'd had an ablation where my stroke risk was especially high when I could not take an anticoagulant for a few days.  That's when my EP switched me to Eliquis.  Even though it may take a while to perfect Andexxa....it is good to have it available for anyone who has a life threatening or uncontrolled bleed.  I hope the ERs in our hospitals will soon have it stocked for situations like that and know when, if, and how to use it effectively with little risk of adverse effects.

    Always hoping for new and better meds for those of us with A-Fib,

    Jean

    (My A-fib Experience Community Leader)

  • Rbrandt
    Rbrandt, May 8,  2018  2:52pm EST

    Wiggles, i hear what your saying.  I always shake my head at TV commercials where most of the commercial is listing side effects.  It always slays me when they say and if your allergic to this med dont take it. Now on a new med how in the ^%$# do you know if your allergic to it? Anyway, i am glad to see the reversal agent especially since I just went thru some intense bleed issues myself.  I guess my assumption here is that at least this drug wouldn’t be used in long stretches and probably mostly in hospital setting and /or under doctor supervision. Which hopefully would reduce the severity of any side effects.  It doesn’t surprise me that stroke increase is a risk since thats the main reason for taking it to reduce stroke risk.  I know in my case I ended up off of eliquis for right at 7 weeks which although I stayed in NSR my risk of stroke went up and I wasn’t very happy about that either. Hopefully we wont need to use but i think i would be ok with it in the short term. 

    May we all have NSR 

    Roy. 

    (MyAfibExperience Community Leader) 

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