Yourlawyer.com (NAION News)

Parker & Waichman, LLP Files Suit Against Pfizer Inc. On Behalf of Victim Diagnosed With Non-Arteritic Anterior Ischemic Optic Neuropathy, NAION, After Using Viagra for 4-1/2 Years - PFE

Tue, 18 Apr 2006 00:00:00 -0700

Parker & Waichman, LLP (http://www.yourlawyer.com) announced that it has filed suit against Pfizer Inc. (NYSE:PFE) on behalf of a victim who was diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy, or NAION, after using Viagra for 4-1/2 years. In July 2005, the FDA issued alerts to physicians and patients about potential vision loss associated with the use of Viagra.

The suit, which was filed on behalf of the victim and his wife, was filed in United States District Court for the Southern District of New York. For more information on Viagra or NAION please visit http://www.viagra-vision-loss.com or http://www.yourlawyer.com/topics/overview/Viagra.

The plaintiff was diagnosed with NAION after using Viagra from July 1998 to January 2003. Prior to this diagnosis, the plaintiff did not suffer from any serious eye or vision problems. The plaintiff has incurred significant economic losses, including lost pay and medical treatment expenses, which will continue in the future. The suit seeks damages from Pfizer for the defective design of Viagra, and for the failure to warn consumers about the potential risk of vision loss that is associated with the drug.

NAION is a vascular event that occurs when blood flow to the small arteries that supply the optic nerve is decreased or blocked. The lack of blood supply to the optic nerve causes damage to the nerve, which may result in permanent vision loss in one or both eyes. NAION is usually permanent and often leads to legal blindness. NAION usually develops without pain, and patients often awake one morning with reduced vision or total vision loss in one or both eyes. The condition typically worsens over the next one to two weeks. Risk factors normally associated with NAION are age, diabetes, high blood pressure, high cholesterol, smoking and other eye problems.

The July 2005 FDA alerts about NAION were issued after the agency received 43 reports of varying degrees of vision loss, including blindness, among users of erectile dysfunction drugs. The FDA stated that 38 of the 43 reports it received were from Viagra patients, and that six patients had vision loss within 24 hours after using the drug. After the FDA alerts were issued, Pfizer added a section to the "Information for Patients" section of the Viagra label notifying patients that a potential link between Viagra and NAION may exist. Over 30 million men worldwide have used an erectile dysfunction drug since Viagra came onto the market in 1998.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca.

CONTACT: Parker & Waichman, LLP
         Jason Mark, Esq.
         Melanie H. Muhlstock, Esq.
         1-800-LAW-INFO
         1-800-529-4636 -- toll-free
         info@yourlawyer.com
         http://www.yourlawyer.com

Consumer Advocacy Group Petitions for Blindness Warning on Viagra, Levitra, and Cialis

Wed, 21 Sep 2005 00:00:00 -0700

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored. NAION is one of the most common causes of abrupt vision loss in older individuals.

People with diabetes and heart disease are specifically at risk for developing NAION. Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra. Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs. The only acceptable solution, he says, is for a black-box warning to be issued.

Consumer Advocacy Group Petitions for Blindness Warning on Viagra, Levitra, and Cialis

Wed, 21 Sep 2005 00:00:00 -0700

Consumer Advocacy Group Petitions for Blindness Warning on Viagra, Levitra, and Cialis

Wed, 21 Sep 2005 00:00:00 -0700

Consumer Advocacy Group Petitions for Blindness Warning on Viagra, Levitra, and Cialis

Wed, 21 Sep 2005 00:00:00 -0700

Get Eye Test Before Using Viagra: Expert

Sat, 06 Aug 2005 00:00:00 -0700

Men should have their eyes checked before taking impotency drugs like Viagra, or risk going blind, a leading international ophthalmologist says.

Professor Neil Miller, of Johns Hopkins Hospital in Baltimore, said drugs such as Viagra, Cialis and Levitra had the potential to lower blood pressure, putting some patients at risk of having a stroke in the optic nerve.

He was talking outside an ophthalmology conference on the Gold Coast which was told of two Australian cases of men in their 60s who had suffered vision impairment after taking Viagra.

"Almost nobody goes completely blind, but they can have significant visual loss in one eye," Prof Miller said.

Although there's been less than 20 cases of vision loss reported among people taking the drugs out of many millions of prescriptions worldwide, he said the extent of the problem was difficult to assess.

"We haven't asked the patients the right questions and not every ophthalmologist who sees a case winds up reporting it," Prof Miller said.

Another complication is that patients who suffer vision loss of this type a condition known as non-arteritic anterior ischemic optic neuropathy (NAION) are of an age where they could be at risk anyway from the effects of hardening of the arteries, hypertension, diabetes or other conditions.

For example, ophthalmologist Peter Cranstoun said the two Australian cases reported by a visiting medical officer at Brisbane's Princess Alexandra Hospital had other health issues which may have impacted on their eye problems.

Prof Miller recommended patients considering going on an impotency drug should have an eye examination to assess their risk of an optic nerve stroke.

He said people who developed NAION usually had a smaller than normal optic nerve head, also called the optic disc.

Optic nerve heads normally look like a circle with a depression in the centre, known as the optic cup.

In most people, the cup takes up about 30 to 50 per cent of the diameter of the optic nerve head.

Prof Miller said those at risk of NAION also had a much smaller optic cup.

"The implication is that all the nerve fibres are crowded into a much smaller space," he explained.

"You can think of it as a room with say, 100 people in it.

"Put those 100 people into a room that's half that size and they're all crowded together. They can't breathe, they can't walk around.

"Then something happens that reduces the oxygen and that's what tips them over the brink."

Prof Miller said impotency drugs worked by dilating blood vessels, allowing more blood into the penis, causing an erection.

"But they also dilate general blood vessels and when that happens, blood pressure can fall."

Dr Cranstoun suggested general practitioners should examine patients' eyes before prescribing Viagra.

"If there's a question about the optic disc - what we call a disc at risk - then they could ask an ophthalmologist for an opinion," he said.

Queensland branch members of the Royal Australian and New Zealand College of Ophthalmologists are on the Gold Coast for their annual scientific meeting.

The US Food and Drug Administration recently ordered that labels for impotency drugs contain a warning about vision loss.

A spokesman for Pfizer Australia, which markets Viagra, said the labels on the drugs sold in Australia had been amended to reflect the "extremely rare" possibility of developing NAION.

He said the amendments followed consultation with the Therapeutic Goods Administration (TGA).

Report from UK Links Viagra to 102 Deaths

Mon, 01 Aug 2005 00:00:00 -0700

Breaking News:

If the news coming out of the UK is accurate, and there is no reason to doubt the credibility of the story, Pfizer Inc. is about to face a major crisis with respect to its blockbuster erectile dysfunction (ED) drug, Viagra.
According to a breaking story, the Daily Mail (UK) is reporting that: “Government figures show that since the drug was launched seven years ago doctors have reported 102 deaths linked to it.”

This report linking Viagra to a significant number of deaths follows recent claims that the drug may also be responsible for cases of blindness and other serious side-effects including heart attacks, angina, eye pain, and vomiting.

While the report suggests that some of the deaths may have been caused by the drug “exacerbating existing heart conditions, particularly in men with blood-pressure problems,” many may be the result of “unfit men overexerting themselves.”

According to Dr. John Griffin, former editor of the medical journal Adverse Drug Reactions, the true death figures could be up to 10 times higher than government records show since previous “research has shown that only one in ten adverse drug reactions is reported. That means in the case of Viagra the real number of deaths may 1,000.”

In the U.S., newsinferno.com recently reported a federal lawsuit has been filed by James Thompson in the United States District Court for the Southern District of Texas seeking monetary damages for the loss of vision allegedly caused by the use of Viagra.

Mr. Thompson also seeks class- action certification on behalf of all other men injured by the drug. The lawsuit charges that Pfizer failed to warn the public that taking Viagra could cause blindness.

The FDA has disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of irreversible blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra). NAION restricts the flow of oxygenated blood to the optic nerve.

To be sure, NAION is a very rare condition and the FDA was quick to point out that a definite link between the drugs and the condition has not been established. Yet, the possibility that such a serious side-effect exists was enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION.

Pfizer has taken the position that its drug does not cause NAION and that a class-action is inappropriate. The company claims that NAION shares a number of common risk factors with ED, including high blood pressure, diabetes, and high cholesterol.

Pfizer (Viagra) said it was considering a label change while Eli Lilly (Cialis) had already added a reference to the reports of NAION. GlaxoSmithKline (Levitra) had not made any public Statement on the matter.

On July 8, the FDA approved updated labeling for Cialis, Levitra, and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION.

The FDA advised patients to stop taking these medicines, and call a doctor or healthcare provider immediately if they experience sudden or decreased vision loss in one or both eyes.

Further, patients taking or considering taking these products should inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again.

The FDA stated that: “At this time, it is not possible to determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems.” The manufactures contend their drugs are safe and not the cause of these problems.

In a release which followed on the heels of a July 8 announcement by the FDA that it was approving updated labeling for Viagra, Cialis, and Levitra to reflect the possible link between these ED medications and sudden vision loss, Health Canada issued a similar Advisory.

Viagra Cialis Levitra NAION Vision Injury Side Effects Lawyer

Mon, 01 Aug 2005 00:00:00 -0700

NAION (Nonarteritic Anterior Ischemic Optic Neuropathy)

NAION (Nonarteritic Anterior Ischemic Optic Neuropathy) is the leading cause of sudden vision loss in people over the age of fifty (50). NAION is estimated to affect as many as 6,000 Americans each year. In a recent study, US researchers describe seven patients who developed nonarteritic ischemic optic neuropathy (NAION), an eye ailment that can result in permanent vision loss, after taking Viagra (sildenafil) for erection difficulties. Combined with past reports, this study brings the total number of sildenafil-related NAION cases to 14.

"For years, we've known that a number of men who take Viagra will experience short-term color changes in their vision and see things as green or blue," study co-author Dr. Howard D. Pomeranz, from the University of Minnesota in Minneapolis, said in a statement. With the exception of one patient whose symptoms began 24 to 36 hours after using Viagra, the patients developed symptoms within 24 hours of use.

In all patients, the initial symptoms were blurred vision and some degree of vision loss. In one patient, both eyes were affected, whereas in the remainder, just one was involved. Three patients had preexisting eye problems that may have increased their risk of NAION.

A few cases of NAION have also been found in patients taking Cialis and Levitra.

If you or a loved one has taken Impotence drugs and been diagnosed with NAION (Nonarteritic Anterior Ischemic Optic Neuropathy), please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.