Pradaxa Are These Side Effects

My mum has been on Pradaxa since they first came out a few years now.Her weight has increased dramatically around the abdomen it does not look like normal fat?? Her arms and legs are now the same, she is a vegan and does not eat a lot.Breathlessness is an issue which then causes her problems when walking.Any ideas

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Hi- I hope you have taken some steps to consider the alternatives, it sounds like she is encountering some adverse reactions but under the current FDA processes governing the release of new medicine, it will be impossible to determine if the reactions are related to the drug unless she gets off it for the 3-5 days it takes to clear out of her system. Having witnessed the process with an “insiders” view, I’ll share my concerns about how these well-marketed drugs are being prescribed under some faulty assumptions physicians may not even be aware, no longer apply. I am the daughter of a vascular surgeon and niece to an interventional radiologist, both very familiar with anti-coagulants. When their mom stopped driving, I was happy to “fill-in” as a chauffeur and frequent visitor to take my gma to the grocery store or evaluations for her warfarin. She was 90, taking cumadin for as far back as I could recall but I was the first one to realize dementia was just starting to become an issue. She would mess up her doses and in the battle for her independence, I served a convenient role as unofficial care-giver, I could be expected to help as needed and a consensus of wishful thinking maintained the idea that she required little if any help so discrediting my voiced concerns became a family sport until her dementia was finally recognized and appropriately addressed. Pradaxa was introduced as a regime change to circumvent the risk posed by her untreated symptoms of the dementia...

It had rave reviews in all the literature littering my dad's and uncle's offices and homes so when the cardiologist said lets try it, it was well-accepted by patient and family and afforded all more time to pretend she was not slipping cognitively. Roughly 3 months into treatment, she suddenly lost vision in one eye. It was not difficult to discern that Pradaxa was a culprit, she had basically been doing the same things for 90y and this was the only change, she takes no other meds, has her own teeth, makes her clothes, had made all her own food from scratch for 85y, no injury, no other changes to anything- BUT pradaxa...

Her sons' connections had her seen, evaluated, and referred, then seen and evaluated some more by some of the top national specialists, by the end of the week!! As the chauffeur and middle man reporter, it was shocking to me to see how rigidly all the MDs stood against the mere question of possibility of pradaxa being culprit (and I quote) “I have checked into the side effects and its not even mentioned so zero, there is a zero chance pradaxa had anything to do with this". Yet, as merely the dopey grandkid who did not go to medical school, even I could perceive the error of that trained response... if by discovery of a logical fallacy alone: it is impossible to prove a negative so Pradaxa was not being considered for reasons other than logic and proof. This was worrisome and here’s what I found ... Doctors, especially the older more experienced specialists are completely clueless that the legacy of FDA safety standards that once served the US public, no longer exists as the framework for their faith in new med approvals.

They were willing to accept medical nonsense before questioning a new drug, saying. “Nonna is getting old, 90y is a long time to expect a body to work as well as hers”. Basic reasoning that adversity consequent to aging is a gradual decline and that sudden, pronounced changes occur by cause, not age, went out the window without a second thought....apparently I was the only one who had time to look beyond the marketing material and do some research into “common side effects”, and learn how the term had been recently redefined by the new FDA standards. No longer is a new drug evaluated for its own merit, thereby establishing direct links to actual effects of real patients trying the actual drug. Adverse effects are determined by drug class, not actual populations evaluated by the actual medicine being prescribed because the sample size required for the initial trials is too small to establish statistical significance of side-effects unique to that drug. In other words, if trials reveal a trend of adverse effects that vary from what is already known about the drug class, it is the drug manufacturers’ responsibility to either reclassify the drug or ignore the data. Not a single doc in the process of evaluating her was even aware the new FDA standards permit an entirely new drug to ride the coat tails of other drugs in the same class. Manufacturers get to forego the lengthy “office trials" once required but still assumed by most prescribing docs, but even if every patient reported going blind in one eye after taking pradaxa, the sample sizes required for approval are too small to establish new standards for the class overall. It is no conspiracy, it is corruption of truth and the governing ethics of those regulating the public interest in healthcare and medicine.

In your instance, swelling around the limbs or feet is a common side-effect of many meds.. but you are wise to question the application of what is generally expected about abdominal swelling (“gas”). It makes no sense to be comforted by physician certainty about the safety of this medicine, based on the very requirements of approval and the rules of logic... so, be armed knowing that by our country’s corruption of what was once legitimate and solid standards for public interest and safety, there is not enough data for your physicians to NOT be concerned. Here is what I suggest: ... try to get her doc to agree to purge the medicine out of her system for 72-96h "just to see”. Be scientific about it and takes some measurements with scale and tape measures, note her weight daily for a week, keep track of what she eats (keep her on a non-gassy food diet for that week) take a base-line measure of those areas that swell- a few times a day and look for trends ..for at least a week before proposing anything to her doc. Point out if she starts to swell within a certain time of taking the medicine and when the swelling decreases... take notes of all of it so when she stops..you will continue taking measurements to compare and be ready to demonstrate there is an improvement if there is one bc unlike vision, it may be something you have to argue on your own evidence and doctors like evidence, yours has to be presented for it to compete with what Pradaxa has already convinced your doc... and pray because of all players in this game... it is our Manufacturer who has the most invested in us and ultimately calls the shots about our healing and well-being.
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As far as my grandma and her vision, I have to give credit to God and His word... which I had just started reading at the time... though I was troubled about the FDA standards, my suspicion was groundless, until I stumbled across a web page where some lady said her son took pradaxa, lost vision, stopped the meds and it came back... The cardiologist mocked me a little with his requirement that she get back on the meds after 72h (expecting the vision issue to remain)... I spent the weekend on my knees and prayed before during and after .. and obviously, God wanted to remind everyone who is in charge of what; almost exactly to the minute of 72h after she got off Pradaxa her vision returned; 6y later, she still sees fine.

It’s really remarkable to me how reluctant all parties were to assign blame to Pradaxa and credit to God. Personally, I don't need statistical significance to know Pradaxa hurt my grandma, God gave me the understanding to do my job for my grandma for His Glory, just like His word promises... in the process I learned the FDA does nothing and therein, I share this info so it may help anyone and remind all that God deserves all the glory for everything. I wish you relieve from these troubles.

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Elisaa Hi thanks for letting me know of your grandmas experiance with Pradaxa I will consider what you said the swelling doesn't, come and go it,s there all the time. She does not eat fatty foods at all That type of food disagrees with her. As she is a vegan the weight/fat issue is a worry. Thanks for your time

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