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Strokes, Blood Thinners, Bleeding Out: FDA Foolishness and a need for New Rules


Douglas A. Wallace
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In 1994 at the age of 65, this writer suffered a stroke of the cerebellum [the lower part of th brain] often referred to as the primitive brain. The stroke had been preceded by several months of random TIAs [Transit Ischemic Attacks]. The TIAs were an embarrassment when the wrong words were coming out of my mouth and if in a semi-public setting, a retreat to privacy was in order until the attack passed. It took several years to become fully aware of what the attacks were and the need to get past embarrassment and seek immediate medical assistance when they occurred.

Between the first TIA, which occurred in the fall of 1991, and the stroke that occurred on my 65th birthday in 1994, I probably had eight to ten TIAs.

After the stroke, I received aspirin and cholesterol-lowering drugs. Years later, in June 2000, I awoke to a full-blown heart attack. I had heard others describe the feeling as the weight of an elephant on your chest and now I could concur. That day a stent was placed in my heart and a month later I had open-heart surgery. A pace maker was implanted in December 2010 which left a blood clot in my left arm. That incident was my first introduction to a blood thinner, which was used to remove the clot. The thinner was warfarin or Coumadin [sometimes used as rat poison], which needed twice-weekly monitoring of keep blood levels. After six months, with no further evidence of a clot, I was taken off Coumadin.

About a year ago, July 2014, my cardiology team became concerned about my susceptibility to a stroke and urged me to start on a regular regimen of blood thinner for the remainder of my life.

Remembering the inconvenience of Coumadin monitoring, I was told there were then three blood thinners (Xarelto, Eliquis, and Pradaxa) that did not require monitoring. I opted for Pradaxa, which consisted of two capsules per day. But when it came time to get the next three months' supply via Costco, I learned the insurance co-pay on the formulary had tripled. An economic decision was made to change to Xarelto, which had a lower co-pay.

My partner and I usually watched the evening TV news as we ate and I recall commercials for two of the blood thinners--happy actors pretending to be the smartest persons alive as they hustled about supposedly beating the odds of a stroke while the voice of a commercial fast talker spewed out the positive and negative merits of the medication, blah, blah, blah, blah, blah! I never remembered hearing or noticing words like "fatal bleeding" in the jumble. After all, it is expected the FDA protocols are in place.

Since February or March 2015 I was happy as I thought myself safe from stroke. At age 86 that is a sure comfort! But things changed.

Just before noon on June 15, 2015, I felt numbness in my left hand that migrated to my left face--very possibly a stroke. Most everyone knows there is a 3-hour window to treat a stroke provided you get to a hospital. A call to a nurse's clinic urged that visit. It was not an ambulance necessity so a trip in the car was made to the closest of a network of hospitals and urgent-care facilities in Reno.

Upon arriving with the announcement of a possible stroke, the ER went into immediate active mode. Registering in could wait. All of the usual testing was done with strips attached to my chest along with a CAT scan. After an hour or so the ER doctor showed up, sat down in a chair and asked me why I came there. I said I thought I had symptoms of a stroke. "But you are on Xarelto. We can do nothing for you here!" Apparently a patient on blood thinners other than Coumadin needs to seek a facility especially set up to handle strokes.

I had been urged by at least five doctors and a nurse practitioner to get on a blood thinner because over the past 30 years I have had strong indications that a stroke was a real possibility. Now after almost a year on a blood thinner I had a stroke. No one had told me that a stroke while on a blood thinner could only be handled by a single facility!

Blood thinners are designed for a single purpose: to prevent blood clots in the brain and the rest of the body. While on blood thinners, however, the blood becomes so thin that it is unstoppable in serious situations; even tourniquets may be ineffective. In such cases, all effort to stop the blood flow fail, resulting in bleeding out and death.

That is why a major hospital facility is required for a stroke victim on blood thinner. They have complete facilities for blood transfusion that would be needed in the event of bleeding out.

The ER doctor I spoke with was explicitly against the use of any blood thinner except warfarin [Coumadin] for the simple reason that vitamin K is a natural antidote to warfarin--injected, vitamin K can thicken the blood very quickly. The other blood thinners have no such antidote.

I switched back to Coumadin, but this issue raises other questions.

Widespread television commercials project an over-happy clientele pushing the product without serious discussion of bleed out.

Why does the medical field fail to fully apprise its patients on the risk of bleed out while on blood thinners?

And why does the FDA not require that each pharmaceutical company that develops its brand of thinner also develop and produce an antidote to diminish the possibility of bleed-out?

Failing to do that tells me that the FDA has loosed a killing "medication" on the market for which it needs to have its butt kicked! Because I have only recently stumbled into this arena I feel it important enough to start a petition on Change.Org to put some pressure on the FDA to clean up this fraud of pharmaceutical companies that are pushing known hazards on America's ignorant but willing elderly and generating wealth from their victims.

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Retired Designer-Builder formerly practicing Attorney at Law.

Credentials include ordaining a Black man to priesthood in the LDS Church leading to a public struggle with the church yielding and ordaining Black men about 2 years (more...)
 

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