A Promising Drug With a Flaw was the name of an article published in the New York Times this past week.
Dr. Bryan A. Cotton, a trauma surgeon in Houston, had not heard much about the new anticlotting drug Pradaxa other than the commercials he had seen during Sunday football games. Then people using Pradaxa started showing up in his emergency room. One man in his 70s fell at home and arrived at the hospital alert and talking. But he rapidly declined. “We pretty much threw the whole kitchen sink at him,” recalled Dr. Cotton, who works at Memorial Hermann-Texas Medical Center. “But he still bled to death on the table.” Unlike warfarin, an older drug, there is no antidote to reverse the blood-thinning effects of Pradaxa. “You feel helpless,” Dr. Cotton said. The drug has contributed to the bleeding deaths of at least eight patients at the hospital. “And that’s a very bad feeling for us.” Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim.
Pradaxa has been linked to more than 500 deaths in the United States, demonstrating that in our current civilization it is fine to make a fortune killing people. Though a chorus of complaints has risen from doctors, victims’ families and others in the medical community, the FDA is not worried that its approval process was not sufficiently rigorous.
“Pradaxa was identified as the primary suspect in 542 patient deaths reported to the FDA in 2011, and was linked to more reports of injury or death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices, a nonprofit based in Pennsylvania that monitors medicine safety,” reported the Times.
They are not at all concerned that they allowed a dangerous drug to be sold without an option for reversing its effects. They sleep at night, the whole lot of them over at the FDA, CDC and all the other health and medical organizations in the United States and Europe knowing that over 100,000 Americans die from their properly-prescribed medicines each and every year.
The Food and Drug Administration released a report on Friday that found that the drug did not show a higher risk of bleeding than for patients taking warfarin. The report did not address the lack of an antidote for Pradaxa.
What does the pharmaceutical company who makes the drug say? “In other words, the drug is still safe. But some reports have indicated that doctors are not sufficiently cautious when prescribing Pradaxa, giving the drug to older people or those with kidney problems even though there is evidence that the bleeding risks are higher in those groups. The company recommends testing patients’ kidney function before prescribing Pradaxa and notes that the risk of bleeding increases with age,” reports the Times.
Magnesium deficiency can cause metabolic changes
that may contribute to heart attacks and strokes.
National Institute of Health
The hidden subject, and one of the most important for the world of medicine, is that this anti-clotting anti-stroke medicine is no match for magnesium chloride when it comes to either treating or preventing strokes. Magnesium chloride is a true medicine where Pradaxa is a true pharmaceutical poison especially designed to make money not heal people of their diseases.
In my practice the use of magnesium in the early
stages of a stroke has rendered the best results
for my patients who have the greatest deficits.
Dr. Al Pinto
In Los Angeles, California, the FAST-MAG trial, has ambulance personal injecting magnesium sulfate quickly upon arrival to stroke victims. The Field Administration of Stroke Therapy (FAST-MAG Trials) is an NIH-NINDS-sponsored study whose goal is to evaluate the effectiveness and safety of field-initiated magnesium in improving the long-term functional outcome of patients with acute stroke.
The FAST-MAG trial addresses the crucial factor of delayed time to treatment that has hindered all past human clinical trials of neuroprotective drugs. The FAST-MAG Pilot Trial demonstrated that field initiation of magnesium in acute stroke is feasible, safe, and potentially efficacious. The basic design is to inject magnesium within 1-2 hours of onset of stroke when the benefits of neuroprotective acute stroke therapies are likely to be greatest. By utilizing field delivery via the ambulance, medical scientists are conducting the first neuroprotective study ever performed in the 0-2-hour window.
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Most stroke patients typically don’t receive treatment within these brief windows. Patients typically arrive at the hospital too late; and the consequences as such are great. Now many stroke patients are being given magnesium sulfate within 30 minutes and in July 2012 it was also reported that 37% of FAST-MAG ischemic stroke patients received TPA, the clot-dissolving medicine tissue plasminogen activator. This high treatment rate will allow FAST-MAG to identify any potential synergistic benefits of magnesium and TPA.
Researchers believe that magnesium slows the chemical process that can kill 12 million brain cells per minute during an untreated stroke, leading to long-term disability and death. So every moment is crucial to outcome. At least nine preclinical studies have examined the effect of systemic magnesium sulfate upon final infarct size in animal focal ischemic stroke models. Eight of the nine demonstrated substantial decreases in infarct size in treated animals, with reductions ranging from 26-61% in studies.
Early studies using rats and mice showed that if given at high
concentrations, magnesium can decrease the area of the
brain that is permanently lost as a result of a stroke.
Dr. Jose Vega
Dr. Gregory Lip, professor of cardiovascular medicine at the University of Birmingham, says that the majority of strokes are preventable, but under-diagnosis and poor care, as well as under-use of medicines and the side effects of drugs means stroke creates “an unnecessary and heavy burden” on patients and health systems. Stroke is the most common cardiovascular problem after heart disease and kills an estimated 5.7 million people worldwide each year.
“How does magnesium protect the injured brain?” asks Dr. Vega. “The response to a lack of oxygen and nutrients (i.e., ischemia) by the brain includes a local release of chemicals which can damage brain cells, even beyond the damage that can be expected by ischemia alone. Perhaps the most harmful of these chemicals is glutamate, an amino acid used in very low amounts by brain cells to communicate with each other. During a stroke, however, the massive amount of glutamate released produces a flood of calcium inside brain cells, which in turn causes them to die prematurely. Magnesium is thought to have the ability to prevent glutamate from causing this flood of calcium in the cells, thus protecting them from premature death.
Dr. Vega continues, “If magnesium infusion is found to be an effective approach for the treatment of acute stroke, it would be a much needed addition to the current armamentarium of medical therapies. Currently, less than 10% of stroke patients can benefit from tissue plasminogen activator (TPA) infusions partly because of the 3-hour limit after the onset of stroke symptoms in which it can be used, and partly because it is contraindicated in hemorrhagic strokes.”
An essential prerequisite for any pharmacological agent to offer significant brain neuronal protection during strokes is its ability to freely cross the blood-brain barrier. Several studies show that magnesium crosses the blood-brain barrier in both animals and in humans. Magnesium ions cross the intact blood-brain barrier efficaciously so that intravenous magnesium sulfate or chloride significantly raises cerebrospinal fluid and brain extracellular fluid magnesium to supraphysiologic levels.
Ancient Minerals has put together a page on their site that makes it easy to tell if you are magnesium deficient. But don’t expect mainstream allopathic doctors to even think about magnesium. They will not be asking these questions or be predicting heart attacks or strokes anytime soon.
Prescription drug deaths now outnumber other deaths in the U.S. Prescription medications have become the leading cause of illness, disability, and death. Many medications’ side effects are worse than the conditions for which they are prescribed. These deaths are from accidental overdoses, from the inherent side effects of the drugs, and also taking two or more prescription drugs at the same time.
Most drugs approved by the FDA are under-tested for adverse drug reactions, yet offer few new benefits. Drugs cause more than 2.2 million hospitalizations and 110,000 hospital-based deaths a year. Serious drug reactions at home or innursing homesare not counted in this number, so certainly the number of deaths is significantly higher.
Special Note: If you suspect a loved one is suffering a stroke, if you have access to magnesium oil, while waiting for the ambulance, rub the magnesium all over the person’s body or, in the case of a child, quickly put the child in a bath loaded with magnesium chloride (recommended are 2-5 pounds of magnesium flakes in a full bath for an adult with an added pound or two of sodium bicarbonate with much less for children of course. This will not replace an injection of magnesium that could be offered by the ambulance operators (but is usually not, except in L.A.) but it opens up quick intervention that will help. One can also drink magnesium chloride. The point is: the quicker one intervenes, the greater the chance of a quicker and more complete recovery.