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FDA Probes ED Drug Blindness Claim

jweiss123 — Tue, 27 May 2008 14:11:37 +0000

(CBS/AP)Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra and Cialis, a disclosure that comes at a time when the drug industry can ill afford negative publicity about another class of blockbuster medicines.

The Food and Drug 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 42 reports of the blindness, 38 among users of Viagra and four among users of Cialis. There were no cases reported among users of Levitra, the third impotence drug.

“We take this seriously,” said FDA’s Cruzan.

The FDA is in about the reported cases with the manufacturers of the three drugs in case there is a problem with the class of medication and to see if changes need to be made to their labels.

Eli Lilly & Co., which markets Cialis with ICOS Corp., refers to vision problems as an uncommon side effect, including seeing a blue tinge or having difficulty telling the difference between blue and green. “These are not all the side effects of Cialis,” it says on its Web site.

Viagra manufacturer Pfizer Inc. also refers on its Web site to some vision issues: “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.

A spokesman for Lilly, Dan Collins, said the Indianapolis-based company had no immediate comment.

Levitra is sold in the United States by PLC and Schering-Plough Corp. and overseas by Bayer AG.

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, told CBS News Correspondent Sharyl Attkisson, who was the first to report the story, that it made sense that Viagra 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.

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.

Levitra was approved in August 2003, and Cialis in November of that year.

There have been no reports connecting Levitra to blindness, said Michael Fleming, a spokesman for GlaxoSmithKline PLC. “We are confident about the safety of our product,” said Fleming.

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Viagra Report Spurs Reaction

jweiss123 — Mon, 26 May 2008 07:31:09 +0000

(CBS)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 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 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 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 that is at high risk, and that would be the same group at risk for having a stroke.

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Feds Eye Viagra-Blindness Reports

jweiss123 — Sun, 25 May 2008 04:36:36 +0000

(CBS)Federal health investigators are looking into reports that some men who used Viagra may have suffered a new and very serious side effect — blindness.

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 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 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 with the FDA to update the labels to reflect the rare .

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.

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House Says No To Viagra

jweiss123 — Sat, 24 May 2008 03:59:48 +0000

(AP)Impotence drugs such as Viagra would not be covered by Medicaid and Medicare, the government health programs for the poor and the aged, under new prohibitions approved by the House on Friday.

By a 285-121 vote, the House approved an amendment by Rep. Steve King, R-Iowa, to stop the government from paying for the drugs. King said his amendment would save taxpayers $105 million next year alone.

King had earlier commissioned a budget study that found the government would spend more than $2 billion on such impotence drugs over the next decade. The amount spent would greatly increase as the Medicare prescription program begins next year.

“We don’t force taxpayers to pay for face lifts, drugs, hair-growth treatment or vacations, so we should not force them to pay for sexual-performance drugs,” King said. “Medicare and Medicaid were to provide lifesaving medication for the truly needy.”

The Senate has yet to act on the measure.

The vote came as the House debated a spending bill for health and education programs. The underlying bill already contains a ban on providing to sex offenders drugs such as Pfizer Inc.’s Viagra; Cialis, which is marketed by Eli Lilly & Co. and ICOS Corp.; and Levitra, which is sold by GlaxoSmithKline PLC and Corp. in the United States, and by Bayer AG elsewhere.

That provision came in response to outcries after it was revealed that almost 800 registered sex offenders in 14 states have been receiving taxpayer-funded impotence drugs through Medicaid. That prompted other states to search their databases.

But Rep. Nancy Johnson, R-Conn., said that the overwhelming majority of Medicaid and Medicare patients who are law-abiding deserve to receive the drugs, especially men who have lost sexual function after suffering prostate cancer and other life-threatening conditions.

In afternoon trading, shares of Pfizer fell 25 cents to $28.65; shares of Eli Lilly fell 42 cents to $57.10; shares of GlaxoSmithKline rose 3 cents, or 0.1 percent, to $49.18; and shares of Schering-Plough fell 32 cents, or 1.6 percent, to $20.03, all on the New York Stock Exchange. Shares of ICOS rose 33 cents, or 1.6 percent, to $21.18 on the Nasdaq Stock Market.

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More Viagra, Blindness Questions

jweiss123 — Thu, 22 May 2008 22:41:41 +0000

(CBS)For weeks the FDA and Pfizer have been exactly how to change the Viagra label to mention rare, serious cases of eye problems, and even blindness. Now that the maker has agreed to put a new warning on the label, some are concerned about other types of blindness and Viagra, and the problem might be broader than anyone knows, reports CBS News Sharyl Attkisson.

“I’m completely blind in one eye and have about 60 percent vision in the other,” says one man, who took Viagra twice. The man, who doesn’t want to be identified, had a type of stroke in the eye that doctors call “NAION” for anterior ischemic optic neuropathy.

“My eye was having a problem seeing … like someone pulling a shade down on it,” he said.

The FDA is looking into several dozen cases of eye stroke and it’s the subject of an unknown number of lawsuits. But a CBS News investigation finds more links between Viagra and all kinds of blindness.

CBS analyzed four years of Viagra adverse events reported to the FDA. There were eye problems in more than 800 patients with more than 140 cases of partial or total blindness. These reports alone aren’t proof of a direct link, but experts look to them for patterns.

Dr. Alessandra Bertolucci of the New York Eye and Ear Infirmary, treated a 51-year-old patient who permanently lost some eyesight four hours after taking Viagra. She published the case two years ago, while other doctors were writing up their own cases.

“I thought it was to make the public aware, and the agency in charge of checking of the side effect, aware of this event,” says Bertolucci.

Here’s where it gets tricky. Many men using Viagra are prone to eye damage to begin with because they have circulation problems. That’s why they need Viagra. So the argument is you can’t necessarily blame the drug if they go blind.

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Sex, Drugs, And Congress

jweiss123 — Wed, 21 May 2008 16:22:05 +0000

(CBS)Last week, the House of Representatives voted to bar Medicaid and Medicare from paying for Viagra and similar medicines. that often Congress itself is quite impotent, I was surprised that they didn’t have more empathy for those who suffered from this problem. Their reasoning was that the American people should not pay for “lifestyle drugs.” We pay for the lavish lifestyles of oil magnates and other super-rich people who get tax breaks. Isn’t that more offensive to you than paying to help people who have a medical condition?

Considering else going on in the world, whether the government should or shouldn’t pay for these drugs is not a top priority for me. On the other hand, the idea of federal programs paying for these doesn’t bother me, especially when I think about all the ridiculous things that we taxpayers pay for. Billions of dollars are spent on wasteful “pork” projects every year. Some examples over the recent past include authorizing $102 million to study screwworms and a mere $50 million for an indoor rainforest in Iowa. NASCAR gets $92 million in federal economic , while poor Tiger Woods only gets $100,000 in federal grant money for his foundation. In this context, paying for these drugs doesn’t seem all that frivolous to me.

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FDA Warning For Impotence Drugs

jweiss123 — Tue, 20 May 2008 15:28:07 +0000

(AP)The government on Friday ordered warnings onto the labels of Viagra and two other impotence drugs that some users have developed a form of blindness while cautioning that it’s to know if the pills are to blame.

The Food and Drug move comes as the agency is under intense pressure to more aggressively and warn the public about drug side effects.

At issue is sudden vision loss when blood flow to the optic nerve is blocked, a condition called NAION or non-arteritic anterior ischemic optic neuropathy.

NAION is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year. Moreover, risk factors include diabetes and heart disease, two of the leading causes of impotence.

The FDA has 43 reports of NAION among the impotence drug users: 38 for Viagra, four for Cialis and one for Levitra. They include varying degrees of vision loss, including blindness.

Those are rare numbers, given that Viagra alone has been used by 23 million men worldwide since its approval in 1998, according to maker Pfizer Inc.

“It is not possible to determine whether these oral medicines for erectile dysfunction were the cause,” or whether other health conditions triggered NAION in the men, the FDA said in a statement Friday.

In addition to heart disease and diabetes, risk factors include being over age 50, high blood pressure, high cholesterol and smoking.

But FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode.

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Viagra For Women? Not Even Close

jweiss123 — Mon, 19 May 2008 14:19:23 +0000

(AP)Drug companies make $2.5 billion a year selling Viagra, Cialis and Levitra to help men enjoy sex. Since more women suffer from sexual than men, developing a drug that could double those sales would seem to be a no-brainer.

Yet the pharmaceutical industry has failed women miserably there isn’t a single sexual dysfunction drug on the market that can help them. Pfizer Inc. last year abandoned an eight-year Viagra study involving 3,000 women, conceding that its famous blue pill only works for men.

“I hate to say it, but women are much more complex than men,” said Beverly Whipple, the sex researcher who co-wrote “The G-Spot.”

Viagra and its two are rather blunt instruments they work simply, by increasing blood flow down below. Women who take the drugs tend to experience the same physical effect, but this alone rarely satisfies them.

“You are not going to make a product by looking at what works in men and apply it to women,” said Amy Allina, program director at the National Women’s Health Network in Washington D.C. “That does reflect, in part, a lack of knowledge of what is underlying women’s sexual problems.”

The latest research being done by academics, rather than commercial drug companies suggests a neurological solution is needed. Because when it comes to achieving orgasms, women are more affected by mood, self-esteem and other issues of the psyche than men.

While Pfizer and other pharmaceutical titans have abandoned the pursuit of a Viagra for females as too complicated, a growing number of university researchers are reporting progress with the help of brain scanners and other technology.

Yes, they’re watching women’s brains while they have orgasms. And they’re coming to some .

For example, by studying paralyzed women who can still experience orgasm, they discovered that for women, the vagus nerve appears to be quite important, and therefore may be a promising target for drugs. This nerve which is outside the spinal cord carries information to areas of the brain that control mood.

“We basically found the areas of the brains that are activated in orgasm in women,” said Barry Komisaruk, who worked with Whipple on this research, which is being funded by the federal government and the Christopher Reeve Paralysis Foundation.

Brain scans measure the blood flow of research volunteers, whose heads are strapped tightly down inside the noisy machines. When brain cells start firing in a part of the brain that governs a particular emotion or activity, they need more oxygen, which is carried by the blood. During a brain scan, active regions of the brain can be seen lighting up on a computer monitor.

The scans reveal something else about women during orgasms, the pain centers in their brains shut down, and pleasure centers the same ones that become active when people ingest cocaine light up.

But a big problem with these scans done through magnetic resonance imaging is that no machine yet built is designed to simultaneously monitor both the brain and the body. And even if they could, the images’ clarity would be muddied by “background noise” such as hand movements.

That’s why Komisaruk is currently studying the brains of women who can self-stimulate purely through thought an apparently rare attribute that eliminates the noise as he seeks to find out exactly what makes women tick during sex.

“The strange thing is that everyone knows that it all happens between the ears and not between the legs,” said Gert Holstege, a leading sexual researcher at Groningen University in The Netherlands.

In June, Holstege published one of the first studies that mapped brain activity during orgasm for men and women, who were stimulated by their partners.

Among other results, Holstege found that the part of the brain thought to control fear and anxiety the amygdala deactivated during orgasm for both women and men.

He acknowledged that his data for men is a little suspect however because they don’t orgasm long enough to take a proper brain scan.

Brain scanning technology has been available for close to 20 years, but is only now being used to study sex. Researchers attribute the delay to several factors, including managerial skepticism and government reluctance to fund much of the work.

“In the United States people are little more reserved when it comes to sex than in the Netherlands,” said Holstege. He said that his U.S. colleagues told him they’d be afraid to propose such a project to their own bosses.

Sex research using brain scans is only just getting started, and scientists warn that any potential new drugs or even better diagnoses of sexual dysfunction are years away.

Still, many researchers including those at the Kinsey Institute for Research, Sex, Gender and Reproduction at Indiana University see brain scans as an important tool.

“We tried to come to conclusions about the brain through all kinds of detours,” said Erick Janssen, a Kinsey researcher. “This is a much more direct way to do it.”

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Katrina Aid Ends Viagra Subsidies

jweiss123 — Sun, 18 May 2008 13:45:37 +0000

(AP)It took a hurricane to do it, but Congress has finally ended federal subsidies for users of Viagra and other sexual performance drugs.

The Senate on Wednesday passed without debate and sent to the president that ends Medicare and Medicaid payments for erectile dysfunction drugs as part of a package that extends medical help for the poor and provides unemployment benefit aid to states hit by Hurricane Katrina.

“This legislation extends very important benefits for people who live on the edge of poverty,” said Senate Finance Committee Chairman Charles Grassley, R-Iowa.

“And the provision included to offset the cost of these programs that taxpayers shouldn’t have to pay for certain lifestyle prescription drugs through Medicare and Medicaid.”

The measure ends federal Medicaid payments for erectile dysfunction drugs as of Jan. 1, 2006. Medicare payments for such drugs will be terminated Jan. 1, 2007.

Rep. Nathan Deal, R-Ga., who sponsored the original House bill, said the government could save $690 million over five years by stopping federal subsidies for sexual performance drugs.

The savings will allow the government to extend for two years the Qualified program that helps low-income families with their Medicare Part B premiums. It extends for three months a temporary medical assistance program that helps families make the transition from welfare to work.

Deal said the legislation also would provide $500 million in federal unemployment funds to hurricane-affected states to help them pay benefits to out-of-work people: $400 million to Louisiana, $85 million to Mississippi and $15 million to Alabama.

Under Medicaid, the state-federal program for the poor, states will still be allowed to subsidize Viagra and other impotence drugs if they determine such drugs are medically necessary. But they will no longer receive federal matching grants.

Congress has made several attempts in recent years to end federal subsidies for erectile dysfunction drugs, but this is the first to clear both chambers and be sent to the president.

A survey by The Associated Press earlier this year showed nearly 800 convicted sex offenders in 14 states received erectile dysfunction drugs filled by Medicaid.

The bill is H.R. 3971.

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Impotence Drugs Under Attack

jweiss123 — Sat, 17 May 2008 12:03:36 +0000

(CBS/AP)A prominent consumer advocacy group is calling for the government to add the most serious of warnings to the labels of Viagra and other impotence drugs, noting that some users have gone blind.

Public Citizen the Food and Drug Thursday to add black-box warnings to the labels of Viagra, Cialis and Levitra, as well as the hypertension drug Revatio, which is similar to Viagra.

CBS News correspondent Sharyl Attkisson reports that two reasons fueled Public Citizen’s FDA request. First, studies show that people don’t pay much attention to the type of warning that was added in July. They do pay attention to a Black Box warning, which is what Public Citizen is pushing for.

Second, Attkisson adds, there’s new . Pfizer had claimed men weren’t more likely to go blind if they take Viagra. But Public Citizen says in men with similar risk factors, Viagra users are much more likely to suffer a type of eye stroke called “NAION.” And it’s not just a question of eye stroke but other types of blindness.

Attkisson first reported a possible link between Viagra and blindness in May.

A small number of people taking the impotence drugs have developed NAION, or non-arteritic ischemic optic neuropathy, a loss of vision that is frequently .

NAION is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year. Risk factors include diabetes and heart disease, which are also two of the leading causes of impotence.

In July, the FDA ordered less prominent warnings be added to the labels of the three impotence drugs. The warnings noted that some users have suffered vision loss but cautioned it was impossible to know if the pills are to blame.

Public Citizen, however, used FDA data to compare the rates of people who developed NAION while on the impotence drugs with those who were taking Lipitor, the cholesterol drug that is used by people with the same risk factors.

The group found that number of reports of the condition per million prescriptions was 18 times higher for patients taking Viagra and 25 times higher for Cialis compared to Lipitor. The group contends this data more closely associates the risk of blindness with the impotence drugs than the FDA has acknowledged.

The actual number of cases are few: between 1998 and 2004, there were 48 reports to FDA’s database of people taking Viagra the condition. Public Citizen found an additional 50 cases of other visual problems among Viagra patients, the group said in its petition. That’s out of 89 million prescriptions written during that period.

Vision problems reported among those taking Cialis and Levitra number 12, including only two NAION cases, both in Cialis users, according to Public Citizen. Roughly 5.2 million prescriptions for the two drugs were written over those six years.

“It is the Food and Drug Administration’s job to immediately and coherently tell consumers about the risks associated with the drugs they put into their bodies,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a statement. “The agency has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed.”

The FDA, in July, advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes, and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode.