Viagra Report Spurs Reaction 

CBS News 27may2005

Washington — A consumer group says it will soon ask the FDA to add the strongest warning possible – a black box – to Viagra and other drugs in the same class after reports of blindness among dozens of men who used the impotence drugs, reports CBS News Correspondent Sharyl Attkisson.

In some respects, the writing may have been on the wall. The makers of Cialis, a Viagra rival, have updated their label warning of rare cases of blindness. The makers of Levitra say they're unaware of any issue with that drug.

But consumer advocate Dr. Sidney Wolfe flagged the potential risk of vision loss in all three drugs in his book "Worst Pills Best Pills," and he alerted the FDA seven years ago when sporadic reports first surfaced.

"We will be asking the FDA in the next couple of weeks to put a black box warning on all three of these drugs' labeling," says Wolfe, "and also to require when a patient gets a prescription filled, that they get an informative and accurate information sheet that warns, among other things, about vision loss."

On Thursday, Attkisson was first to report that a small number of men have gone blind after taking Viagra.

"I've pretty much accepted that my eyesight is not going to come back," said Jimmy Grant, who started using Viagra in 1998, when he was 57. "But I've also pretty much accepted that Viagra done it."

Eye specialist Dr. Howard Pomeranz was first to flag the potential problem in 1998.

"I can't tell you how many other people have contacted me thinking that there may have been an association," said Pomeranz, "that they had raised the issue with their physicians and their physicians had said, 'Well, I'm not aware of that.'"

The FDA says no definite link has been proven, but agrees the public needs to be warned promptly. Just how to do that is what they're discussing. Pfizer says there's no evidence of more vision loss in men taking Viagra than similar men who don't.

Attkisson notes that when talking about a lable change, there are a lot of discussions and negotiations between the FDA and the drug company. It's unlikely the product would be removed from the market.

CBS News Correspondent Elizabeth Kaledin explains the vision loss is often called "the stroke of the eye." There is a certain group of the population that is at high risk, and that would be the same group at risk for having a stroke.

Those would be men over 50 with diabetes, high blood pressure, heart disease. Coincidentally, that is the same population of men most likely to be taking Viagra, notes Kaledin. So until the FDA can prove or disprove a causal link, that population should really check with their doctor about this.

Viagra and its competitors are blockbuster drugs that revolutionized treatment of erectile dysfunction, and they already come with serious warnings: They're not to be used by men who take nitrate-containing drugs, because the interaction could cause deadly drops in blood pressure, or by men with heart conditions whose doctors have warned that sex itself could be too much exertion

Viagra and its competitors work by slightly dilating arteries so that blood flow in the penis increases. Whether it affects blood flow to the eye isn't known, but Pomeranz argued that some effect on the optic nerve is plausible.

So he urged that ophthalmologists ask patients whether they use impotence drugs, and report any additional cases. Also, Viagra users who suffer blindness in one eye should be cautioned that continued use might raise the risk of vision loss in the other eye, Pomeranz wrote.

Big money is at stake. Pfizer Inc. said in its most recent quarterly filing with the Securities and Exchange Commission that sales of Viagra rose 5 percent — to $438 million — in the first quarter of the year.

Pfizer shares declined Friday on the New York Stock Exchange after news of the blindness cases.

source: http://www.cbsnews.com/stories/2005/05/26/eveningnews/printable698124.shtml 30may2005

Feds Eye Viagra-Blindness Reports

CBS News 26may2005

Washington — 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.

Pfizer Statement Regarding Viagra:

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.

source: http://www.cbsnews.com/stories/2005/05/26/eveningnews/printable698124.shtml 30may2005

Viagra Reported to Cause Blindness 

XINHUA (China) 30may2005

BEIJING, May 30 — US regulators have received more than 40 reports of a type of blindness in men who use Viagra and other impotence drugs, but have not determined if the medicines were responsible.

The Food and Drug Administration (FDA) said it has about 38 reports of the rare condition among Viagra users, four reports among users of Eli Lilly and Co.'s Cialis and one report in a man who took GlaxoSmithKline Plc's Levitra.

In some cases users are getting visual problems within a short time.

While it has been known for years that users of impotence drugs could experience short-term vision changes, seeing green or blueish hues, what has raised the red flags is the immediacy of the drug's impact and its lasting effect.

They say the vision loss — known as non-arteritic anterior ischemic optic neuropathy (NAION) — is caused by a sort of stroke affecting the blood vessels of the eye when they become choked off, eventually causing some of the cells in the eye to die.

Interestingly, the number of people who get this same type of stroke is actually about four times higher for people who don't take Viagra, the study's researchers say.

New York-based Pfizer, Viagra's manufacturer, said it is weighing a change to the Viagra label. But it emphasized no proof exists that links the blindness to the drug, which was introduced in 1998 and had $1.68 billion in sales in 2004.

More than 23 million men worldwide have taken Viagra over the past seven years, Pfizer said. Reports are extremely rare of the condition of NAION, the company said. NAION can cause permanent vision loss in one or both eyes.

Pfizer already warns the drug 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.

source: http://news.xinhuanet.com/english/2005-05/30/content_3020770.htm 30may2005