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New Blue Pill Risks
Scientific research has recently identified three new risks associated with the use of Viagra. These are permanent loss of vision, disturbances in the electrical rhythm of the heart and an elevated blood clotting factor. The latter two resulted in death from cardiac arrest and heart attack (myocardial infarction). Viagra’s labeling addresses the risks associated with vision impairment, dangerously low blood pressure when taken with nitrites, and hearing loss.
There are fewer than 100 cases of permanent blindness caused by Viagra. Fewer than 7,000 cases of cardiac death have been linked to Viagra use. The risks are increased in men with heart disease, high blood pressure, diabetes, high cholesterol, and high lipoprotein levels. Viagra’s interaction with statins is a problem, especially for men with heart disease. Men after a heart attack are in a dangerously high risk group. Some scientists advise men after a heart attack not to use Viagra.
Pfizer received FDA approval for Viagra in 1989. This product created a two billion dollar market for the treatment of erectile dysfunction (ED). Pfizer claims to have 30 million users to date.
Risks to vision:
FDA clinical trials found the side effect of temporary vision impairment associated with light sensitivity and blue-green color distortion. These warnings are on the packaging.
The University of Minnesota has published evidence linking Viagra to non-arteritic ischemic optic neuropathy (NAION). NAION is described as an “eye stroke” that occurs when blood flow to the optic nerve is interrupted. Of the 42 reports of blindness, 38 were related to blindness due to Viagra, and the remaining four were related to Cialis.
Because of this link, the FDA is discussing revising package warnings to include the risk of permanent blindness. Pfizer’s position is that the incidence of Viagra-induced NAION is lower than that seen in the general population and cannot be directly attributed to Viagra use.
Permanent blindness occurs within 24 to 36 hours of using Viagra. There is an anatomical predisposition to permanent vision loss, identified by a low cup-to-disc ratio. This ratio is an expression of blood flow in the connection between the optic nerve and the eyeball. Patients with a low ratio are at greater risk of vision loss when using Viagra. High blood pressure, cholesterol, blood lipids and diabetes increase the risk of permanent vision loss.
Viagra narrows the vestibules in the eye, which causes an interruption of normal blood flow to the eyeball connection of the optic nerve. Some patients experience temporary visual impairment, while others experience permanent vision loss.
As of July 1999, within a year of Viagra’s release, an estimated 16 million men worldwide were taking Viagra. According to the Journal of the American Medical Association, 564 deaths have been reported to date.
The number of cardiac deaths linked to Viagra, Cilias and Levitra is poorly reported. Extrapolating the above data and taking into account the increased number of users would indicate that there have been 7,000 to 10,000 Viagra-related heart attack deaths to date. The numbers above refer to Viagra only. The total for all three ED products would be much higher.
It is difficult to identify the effect of Viagra on cardiac death. Pfizer, Ely Lily and Glaxo Smith Kline manufacture Viagra, Cialis and Levitra. These pharmaceutical giants are motivated to downplay the importance of reporting and manipulate data related to their products. Post-release reporting is not of the same caliber as FDA approval trials. Once a drug is released, it is difficult to corroborate FDA trial data with case studies.
Viagra’s label warns against using it with nitrates, which are used by heart patients with advanced heart disease to relieve angina (chest pain). Both nitrates and Viagra are vasodilators that relax blood vessels and allow more blood to flow through compromised coronary arteries. Combined, this can lead to insufficient blood supply to compromised coronary arteries due to dangerously low blood pressure. You might think of it as an overdose of a vasodilator. Lack of adequate blood supply can lead to myocardial infarction (heart attack), myocardial meaning heart tissue and infarction meaning cessation of blood supply.
There are two additional cardiac dangers that are poorly recognized at this point. The former affects heart patients, while the latter affects men with no history of heart disease. Both resulted in cardiac deaths.
Men with heart disease:
Cardiac deaths fall into two categories, cardiac arrest, which is the cessation of the electrical heartbeat, and infarction, which is the cessation of blood supply to the tissue of the heart shell due to a blockage of a coronary artery, usually due to a blood clot. This risk is associated with electrical stimulation of the heart. There is an interaction between Viagra and common heart medications. The danger is related to the interruption of the normal electrical impulses that cause the heart to beat, which can lead to cardiac arrest.
In the normal cardiac cycle of contraction and rest, regeneration of the electrical potential occurs during the period of rest, preparing the heart for the next contraction. This regeneration of electrical potential is called repolarization. It is most critical in the contraction of the ventricles because these chambers are considered the main pumping component of the heart. The mineral calcium plays a major role in repolarization.
Common heart medications that interact with Viagra include statins such as Zocore and Lipator, calcium channel blockers such as Norvasc and Lotrel, and over-the-counter antihistamines. Viagra, in combination with these drugs, causes QT prolongation (repolarization) in men with heart disease, which can lead to cardiac arrest.
This is the conclusion of a scientific study at the University of Montreal in Québec, Canada. The language is a little technical, but you can get the idea.
Sildenafil (Viagra) blocks IKr and prolongs cardiac repolarization (QT) at concentrations that can be seen after drug overdose (elevated doses, ie 100 mg Viagra) or in the presence of impaired drug elimination (poor renal function). Clinical attention to QT prolongation and triggered ventricular tachyarrhythmias (irregular heartbeat) is warranted in patients with hepatic (liver) or renal (kidney) insufficiency or long QT syndrome (post-heart attack – heart disease) and in patients on multiple regimens of medication (meaning the typical heart patient).
Men without cardiac history:
This risk is related to blood clotting factors, which cause both healthy men and men with heart disease to experience increased clotting, leading to myocardial infarction (heart attack) in both groups. It is difficult to classify the causes of death because the pattern is the same for Viagra users.
Researchers have discovered an unexpected effect of a group of drugs that are supposed to reduce clotting. The research produced a result that dramatically surprised the researchers. Biochemical cGMP has been shown to lower blood clotting factors in past research. However, this new research found that its initial effect was to increase the clotting factor and then decrease it. Previous research has focused on the later effect of downsizing. Scientists have found a dramatic increase in initial clotting (platelet aggregation) when taking Viagra. They characterized the effect in this way. “It’s similar to an external wound. Platelets initially respond by becoming sticky and clumping together (a clot) to stop blood loss. Once that phase is complete, platelets reduce clotting to allow blood flow to heal the wound.”
This elevated blood clotting factor combined with moderately narrowed (ischemic) arteries can trigger a heart attack. Men who are considered healthy may actually be at risk for a cardiac event. Studies have shown that men in their twenties have 50% to 70% blockage. This along with Viagra’s increased clotting effect is like Russian Roulette. You don’t know if your makeup will trigger a fatal event.
On October 18, 2007, the FDA announced labeling changes for Viagra that include sudden hearing loss. Two-thirds of hearing loss cases resulted in permanent hearing loss. Minimal scientific research has been done on the causes of hearing loss in Viagra users. Other diseases cause hearing loss due to reduced blood supply. Given the vascular narrowing documented above in NAION blindness, it seems obvious that this effect may be the cause of hearing loss.
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