The news story that is the subject of this blog entry found people using Viagra are going blind. This story belongs in the Happeh Theory For The Scholar section because it supports the claim by Happeh Theory that Masturbation and Excessive Sexual Activity will make a human being blind and crippled.
It is not the drug Viagra that is making the people blind though. It is the excessive sexual activity that Viagra enables the people to engage in that is causing the blindness.
Viagra is said to give a man an erection for four hours. It is common for sexual activity to usually last fifteen minutes to a half hour, so Viagra is enabling the people to have sex eight to sixteen times longer than is normal.
If a man took Viagra repeatedly, then engaged in sexual activity eight to sixteen times longer than was normal, that would be “excessive sexual activity”, which is what Happeh Theory claims is really causing the blindness.
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Federal health officials are examining rare reports of blindness among some men using the impotence drug Viagra.
The Food and Drug Administration still is investigating, but has no evidence yet that the drug is to blame, said spokeswoman Susan Cruzan.
This type of blindness is called NAION, or non-arteritic anterior ischemic optic neuropathy. It can occur in men who are diabetic or have heart disease, the same conditions that can cause impotence and thus lead to Viagra use.
The
FDA has 50 reports of the blindness. Viagra has been taken by more than 23 million men worldwide.
“We take this seriously,” said FDA’s Cruzan.
On its Web site, Viagra manufacturer Pfizer Inc., states: “The most common side effects of Viagra are headache, facial flushing, and upset stomach. Less common are bluish or blurred vision, or being sensitive to light. These may occur for a short time.” That language had been available before the current inquiry.
Pfizer spokesman Daniel Watts confirmed Friday that the drugmaker was in discussions with the FDA about adding a disclosure to Viagra’s label to say that in rare cases, men taking Viagra had developed blindness. However, he said there is no proof that Viagra caused the blindness. He said that men who take Viagra often have high blood pressure and high cholesterol, which are also associated with the conditions that can cause blindness.
FDA is working with Pfizer to determine what, if any, information about the condition should be added to the drug’s label. The story was first reported by CBS News.
Viagra was approved by the government in 1998. It may aid in the treatment of enlarged hearts that can result from high blood pressure, tests on animals indicate.
Viagra, approved to treat erectile dysfunction, should not be used by men with heart conditions whose doctors have warned them not to have sex. Also, patients taking drugs that contain nitrates have been warned not to take Viagra because of sudden, unsafe drops in blood pressure.
The drug’s label also warns of erections lasting longer than four hours, painful erections lasting longer than six hours, headache, flushed skin and vision problems.
Pfizer Inc., the New York-based maker of Viagra, said in its most recent quarterly filing with the
Securities and Exchange Commission that sales of the drug rose 5 percent — to $438 million in the first quarter of the year. Pfizer also said at the time that Viagra had a 68 percent worldwide market share.
STORY FROM CBS NEWS BELOW _ MORE DETAIL
Federal health investigators are looking into reports that some men who used Viagra may have suffered a new and very serious side effect — blindness.
Twenty-three million men worldwide have used Viagra. A very small number of them are going blind after taking normal doses. And CBS News has learned from the FDA that it is urgently meeting about it with experts and Pfizer.
Jimmy Grant started using Viagra in 1998, when he was 57. At first, he felt pressure in his temples and saw color changes in his vision.
“I noticed the symptoms probably within 45 minutes to an hour,” he told CBS News correspondent Sharyl Attkisson.
Soon, he went blind in his right eye. Doctors didn’t make a connection to Viagra.
“After your loss of vision, did you continue taking doses?” Attkisson asked.
“On occasions, I did,” he said. “And then in March 2000 after taking Viagra I experienced loss of sight — partial loss of sight in my left eye.”
With both eyes damaged, a friend found an article on the Internet about Viagra and blindness, and Grant put two-and-two together.
“What convinced me that Viagra did it was what Dr. Pomeranz had in his report.”
That’s Dr. Howard Pomeranz, an eye specialist who appears to be the first doctor to make a connection in one of his patients back in ’98. To him, it made sense that Viagra — which alters blood flow in key parts of the body — could also affect circulation to the optic nerve.
“And so I thought, well, in both of these situations, blood flow is being altered, so maybe there is a connection between the two,” said the University of Minnesota neuro-ophthalmologist.
He published his patient’s case looking for feedback. By 2001, he had five cases to report to the FDA and Pfizer, the makers of Viagra. Slowly, more reports trickled in.
“So they certainly are aware of this possible side effect of their medication,” Pomeranz said.
The FDA tells CBS News it’s looking at about 50 reported cases of vision loss and, while no direct link has been proven, an FDA medical supervisor says “We’re very concerned. This issue is front and center, it’s a priority. We know people need to know as promptly as possible.”
Pfizer told us its Viagra studies show no report of vision loss and say there is no more evidence of vision loss in men taking Viagra than those who don’t. However Pfizer confirmed it in in discussions with the FDA to update the labels to reflect the rare occurrences.
Jimmy Grant is now spending retirement in a way he never imagined: living with his 83-year-old mother, suing Pfizer, and sorry he ever tried Viagra.
“I’ve pretty much accepted that my eyesight is not going to come back. But I’ve also pretty much accepted that Viagra done it,” he said.
The FDA says it’s monitoring adverse event reports for the similar drugs in the same class as well.
A review of 103 Viagra clinical trials involving 13,000
patients found no reports of non-arteritic anterior ischemic optic neuropathy (NAION). Outside of clinical trials, Viagra has been used by more than 23 million men worldwide over the past seven years and reports of visual field loss due to NAION are extremely rare.
There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra.
NAION is the most common acute optic nerve disease in adults over age 50 and it shares a number of common risk factors with erectile dysfunction: age over 50, high blood pressure, high cholesterol, diabetes. Most of the reported cases in which NAION has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors associated with the development of NAION. This makes it impossible to determine whether these events are caused by the patient’s underlying vascular risk factors, anatomical defects, Viagra or a combination of these factors — or to other factors.
Pfizer is in discussions with the Food and Drug Administration to update the Viagra label to reflect these rare ocular occurrences. Viagra has a strong safety profile and remains an effective medication that benefits millions of patients.