Yourlawyer.com (Viagra News)

Stiff Nights Contains Dangerous, Undeclared Ingredients

Fri, 06 Nov 2009 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Stiff Nights contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra.

Following a consumer complaint, the FDA determined that the product contains sulfoaildenafil and warns that sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and may cause dangerously low blood pressure.

"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”

Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant and use of such products exposes consumers to unpredictable risk and the potential for injury or even death.

Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs, and other compounds that do not qualify as “dietary ingredients.” The FDA has issued multiple alerts about these contaminated dietary supplements.

Stiff Nights is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. Stiff Nights is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

The FDA is advising consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use of these products should also be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online at: www.fda.gov/MedWatch/report.htm]; by telephone, toll-free at 1-800-332-1088; by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm] by mail the address on the pre-addressed form; or by fax to 1-800-FDA-0178.

Viagra, Cialis Amnesia Reports Prompt Labeling Change

Mon, 25 Aug 2008 00:00:00 -0700

The labeling for Viagra and Cialis will now include information about Transient Global Amnesia (TGA), a side-effect that may occasionally accompany use of the erectile dysfunction (ED) drugs. A third ED drug, Levitra, had information about the temporary form of memory loss added to its label in June.

TGA is a sudden, temporary episode of memory loss that can’t be attributed to a more common neurological condition, such as epilepsy, transient ischemic attack, stroke or head injury. During an episode of transient global amnesia, recall of recent events simply vanishes, so a victim is unable to remember where they are or how they got there. They may also draw a blank when asked to remember things that happened a day, a month or even a year ago.

Victims of TGA do remember who they are, and they will recognize family members and others they have known for a long time. When an episode of TGA is over, a victim will remember nothing that happened while their memory was impaired, and might not recall the hours beforehand.

The new information on TGA for Viagra and Cialis does not amount to a safety warning, but will be added to the "Postmarketing" section of the drugs' labels. Such label changes usually mean that multiple users have reported health problems after taking a drug, but the reports don't necessarily mean that the drug caused the problem, according to the Food & Drug Administration (FDA).

Despite a lack of direct evidence linking the ED drugs to TGA, this isn't the first time they have been implicated in the condition. A 2005 article in the International Journal of Impotence Research described the case of a 46-year-old man who was brought to the emergency room because he had couldn't remember any events since waking up in the morning or the night before, taking Cialis. His memory gradually improved, and tests for cardiovascular and brain problems - potential causes of TGA - came back normal. According to the authors of that article, there had been 35 reports of amnesia in Viagra users between 1998 and 2001.

Other side effects have resulted in other labeling changes for Levitra, Cialis and Viagra. In 2005, warnings about vision loss were added to their labels. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

In 2006, a second warning was added to the label of Levitra, Cialis and Viagra regarding sudden hearing loss related to the medications. The FDA said the warning was prompted by more two dozen instances of sudden hearing loss linked to the drugs. In about a third of those reports, the hearing loss was permanent.

Xiadafil Supplements Recalled, Said to Contain Viagra Ingredient

Wed, 28 May 2008 00:00:00 -0700

Today, the U.S. Food and Drug Administration (FDA) requested that SEI Pharmaceuticals of Miami, Florida recall all Xiadafil VIP Tabs sold in eight tablet bottles (Lot # 6K029) or blister cards of two tablets (Lot # 6K029-SEI). Florida officials issued a "stop sale" action at SEI's Miami distribution facility on May 13 that required SEI to hold—intact—violative Xiadafil VIP Tabs found on-hand at the facility.

The Xiadafil VIP Tabs contain a potentially harmful, undeclared ingredient found in the prescription drug Viagra that may dangerously affect a person's blood pressure as well as cause other life-threatening side effects. The lots of Xiadafil VIP Tabs containing the potentially dangerous ingredient, bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and claim to treat erectile dysfunction (ED).

According to the FDA, today's formal request by the agency follows an action by the state of Florida to prevent the further distribution of the Xiadafil VIP Tabs into consumer channels. The FDA is advising consumers not to buy or use this product. The FDA said it might take further regulatory action to protect consumers from this illegal product.

Xiadafil VIP Tabs are labeled as a dietary supplement and hyped as "all-natural"; however, according to the FDA, Xiadafil VIP Tabs are, in fact, an illegally marketed drug that contains a potentially harmful undeclared ingredient. The FDA said its chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra. Viagra is an FDA-approved prescription drug for ED.

Hydroxyhomosildenafil may interact with nitrates found in some prescription drugs—such as nitroglycerin, for example—and can also lower blood pressure to life-threatening levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates; ED is a common problem in men with these medical conditions. "Because these products are labeled as ‘all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."

The FDA said it has not approved Xiadafil VIP Tabs for any use and its safety and effectiveness is unknown. The product is promoted and sold over the Internet, was given away as free samples at trade shows, is sold in health food stores nationwide, and may be distributed in either bottles of eight tablets or blister cards of two tablets.

According to the FDA, alternative products such as Xiadafil VIP Tabs are often sought out because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should be aware that the FDA has not verified the safety, efficacy, and purity of such ingredients.

Viagra Ad Prompts FDA Warning

Tue, 22 Apr 2008 00:00:00 -0700

A Viagra ad has Pfizer in trouble with federal regulators. The Viagra ad, which runs online, does not warn of the erectile dysfunction drug's many side effects, prompting the Food & Drug Administration (FDA) to issue Pfizer a warning letter. For its part, Pfizer insists the omission was nothing more than a technical error on the website where the Viagra ad ran.

Viagra is a PDE5 Inhibitors that relaxes muscles and increases blood flow to certain parts of the body. Viagra, the most well-known of the PDE5 Inhibitors on the market, was approved in 1998 to treat male erectile dysfunction. In October 2007, the Viagra label was modified to include warnings about sudden hearing loss associated with the drug. The FDA had requested the changes after it had received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.

Many men who take Viagra are older, and it is not unusual for this patient population to experience some hearing loss. But that is almost always a gradual process, and sudden loss of hearing is rare. According to the FDA, the sudden hearing loss associated with Viagra was often accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.

The October 2007 label modification marked the second time Viagra users were warned of a serious side effect. In 2005, the Viagra label was changed to include warnings about vision loss associated with the drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

Apparently, a Viagra ad run on CNN.com made no mention of these side effects. In a letter to Pfizer dated April 16, the FDA said "The video raises public health and safety concerns through its complete omission of risk information for Viagra by suggesting that Viagra is safer than has been demonstrated."

Pfizer said that warning information was supposed to appear in print on the screen, but a technical error prevented it from doing so. CNN.com confirmed that a technical error did occur, and that it was corrected. To avoid such errors in the future, Pfizer has pulled all 30-second Internet video ads that require safety information to appear separately on the screen rather than within the advertisement.

FDA Warns on "Blue Steel", "Hero" Supplements

Wed, 26 Mar 2008 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) is warning consumers to not purchase or use both the “Blue Steel” and “Hero” products. Both of these products are being marketed as supplements for erectile dysfunction and sexual enhancement and are being labeled and marketed as dietary supplements throughout the United States. Blue Steel and Hero are considered unapproved drugs—the FDA is calling these products illegal drugs—they have not been proven to be safe or effective and, as a matter-of-fact, the FDA is saying that these illegal drugs pose serious health risks. Blue Steel and Hero products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level.

These products are promoted and sold over the Internet and are advertised as “all natural” and labeled as dietary supplements; however, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances which are similar in chemical structure to sildenafil, the active ingredient in Viagra. Viagra is an FDA-approved prescription drug for erectile dysfunction. "Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."

Blue Steel is sold in bottles containing 10 blue capsules or blister packs containing two blue capsules. Hero is sold in blister packs containing two blue capsules. Both products distributed by Active Nutraceuticals or the Marion Group, Carrollton, Georgia.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs, such as the heart medication nitroglycerin. These products can also lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and erectile dysfunction is a common problem in men with these medical conditions. Because men with these conditions may have been advised against taking medications for erectile dysfunction, they may seek products like Blue Steel and Hero because the products are marketed as "all natural" or as not containing the active ingredients in approved erectile dysfunction medications. FDA chemical analysis revealed that both Hero and Blue Steel contain substances similar in chemical structure to sildenafil; however, they are not components of an FDA approved drug. It’s important to note that these products’ labels do not list any of these substances.

The FDA is advising consumers who may have used Blue Steel or Hero to discontinue their use and consult their health care professional if they have experienced any adverse events which could be related to these products. Also, consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. The FDA recommends consumers speak with their health care professional about FDA‑approved treatments for erectile dysfunction; the FDA may take further regulatory actions to protect consumers from these illegal products.

Phony Viagra, Cialis Pills Seized by French Customs Officials

Tue, 08 Jan 2008 00:00:00 -0800

Men using Viagra, Cialis and other impotence drugs should be sure to get these from a trusted source. That's because the market - especially the internet, is awash in phony impotence drugs.

In a market worth over $3 million and for the millions of men suffering from erectile dysfunction, the boom of fake Erectile Dysfunction (ED) medications is cause for concern. Another cache of fake medications was recently seized when French customs officials intercepted a shipment of 224,000 counterfeit Viagra and Cialis pills worth 2.4 million euros—$3.5 million—the Budget Ministry said Monday. Copies of the drugs were found on December 18th during a search at the French capital's main air hub at Roissy, in a freight cargo on its way to Brazil from India. "Branded Powergra and Erectalis, each box contained, in fact, four tablets in the characteristic shape and color of Viagra or Cialis pills," Budget Minister Eric Werth's office, which in charge of customs, said. "The companies Pfizer and Eli Lilly, which respectively own the Viagra and Cialis brands, quickly confirmed the counterfeit nature of these products and the 224,000 pills were seized," Werth's office added.

Last July, Chinese police seized over a ton of phony drugs including at least 18,000 fake Viagra tablets. Over 30 people were detained on suspicion of either making or selling the drugs. Police in the eastern province of Zhejiang raided the gang making counterfeit Viagra and selling the tablets to 12 countries, including the United States and Holland. In Guangdong, police arrested 12 people and seized one ton of fake drugs, two production lines, and large quantities of raw materials for making "sildenafil citrate," the scientific name for Viagra.

Late last year, Ashish Halai and his group bought counterfeit drugs from Chinese suppliers and sold them to customers who thought they were buying Viagra and Propecia. Their network stretched from Britain to Hong Kong, Dubai, the Bahamas, and the US—to name a few—in Britain’s largest drug counterfeiting case. The fake pills were produced in secret factories in China and Pakistan and smuggled to the US and Europe. Halai and his wife, a pharmacist, ran a legitimate pharmacy for years. When the business was sold, he continued to use the name to sell herbal weight-loss aids. In 2002 he started to deal in counterfeit Viagra, selling via email. He made a deal to supply a Mexican company based in the Bahamas and developed a network of contacts to help him smuggle into Great Britain and ship to the Bahamas. Packages, many of which were shipped with companies such as DHL, were marked as containing vitamin supplements for dogs to avoid detection. The case dates back to 2003 and 2004, when counterfeit batches of the impotence drugs were seized while being smuggled into Heathrow and Stansted airports. Samples revealed the medicines contained about 90 per cent of the active pharmaceutical ingredients found in genuine tablets. Most of the fake pills were sold via the Internet; some were sold as prescription medicines. In 2003, the US Food and Drug Administration seized 8,000 packages of Viagra in Miami. In July 2003, Britain’s Medicines and Healthcare Products Regulatory Agency officers seized over 120,000 fake Viagra tablets.

Viagra, Cialis, Levitra Information Sheet Warns o f Sudden Hearing Loss

Thu, 15 Nov 2007 00:00:00 -0800

Doctors who prescribe Viagra, Cialis and Levitra will need to read up on a new information sheet released by the Food & Drug Administration (FDA) regarding sudden hearing loss associated with the erectile dysfunction drugs. Last month, the FDA warned that Viagra, Levitra, and Cialis have been connected with more than two dozen instances of sudden hearing loss. Those reports prompted the FDA to announce that the labels on these erectile dysfunction drugs would bear new warnings about this potential side effect.

Following the publication of a report in the Journal of Laryngology and Otology, the FDA conducted a search of its adverse event reporting system for cases of hearing loss in patients taking Viagra, Levitra and Cialis. Twenty-nine postmarketing reports of sudden hearing loss defined as new hearing loss occurring over a period of 3 days or less following the last dose, both with and without tinnitus and dizziness, were identified. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs. In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in two thirds of the cases the hearing loss was permanent.

The FDA is advising physicians who prescribe Viagra, Levitra or Cialis for erectile dysfunction to tell their patients to immediately stop taking the drug if they experience any sudden decrease or loss of hearing and seek prompt medical attention. The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information. The new warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra, Levitra and Cialis. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas t
he previous label simply stated “deafness” as a possible side effect.

This is the second time that the Viagra, Levitra and Cialis labels have been changed to warn of a serious side effect. In 2005, warnings about vision loss associated with the drugs were added to their labels. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

Viagra, Cialis, Levitra Users Report Hearing Loss, Prompting New Warnings

Mon, 22 Oct 2007 00:00:00 -0700

Viagra, Levitra, and Cialis have been connected with more than two dozen instances of sudden hearing loss. Last week, those reports prompted the Food & Drug Administration (FDA) to announce that the labels on these erectile dysfunction drugs would bear new warnings about this potential side effect.

Viagra, Levitra and Cialis are PDE5 Inhibitors that relax muscles and increase blood flow to certain parts of the body. Viagra, the most well-known of the PDE5 Inhibitors on the market, was approved in 1998 to treat male erectile dysfunction.   Another PDE5 Inhibitor, Revatio, is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. In announcing the changes to the Viagra, Levitra and Cialis labels, the FDA also said that it was working with the maker of Revatio to update that drug’s labeling to also include warnings on sudden hearing loss.

The FDA’s decisions to change the labeling on Viagra, Levitra and Cialis comes seven months after an article in the April issue of the Journal of Laryngology & Otology published a case report on a 44-year-old man who experienced this sudden hearing loss after taking Viagra for 15 days. Since then, other such cases have been reported. So far, the FDA says it knows of sudden hearing loss occurring in 29 patients taking PDE5 Inhibitors. Many men who use Viagra, Levitra and Cialis are elderly, and gradual hearing loss is not uncommon in this group of patients.   However, sudden hearing loss is highly unusual. As a result, the FDA asked the manufacturers of Viagra, Levitra and Cialis to update the drugs’ labeling to include warnings about this serious side effect.

The previous Viagra labeling did mention that deafness was a possible side effect of the drug, because a few cases were reported during its initial testing. But the new labeling on Viagra, Levitra and Cialis will include much more information.   The new warning on sudden hearing loss will be included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra, Levitra and Cialis. It also says that patients should seek immediate medical attention if they experience a sudden loss or decrease in hearing or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”, whereas the previous label simply stated “deafness” as a possible side effect.

In the majority of the Viagra, Levitra and Cialis users who experienced this problem, the sudden hearing loss occurred within hours to two days of taking one of the drugs. In some of the cases, the sudden hearing loss was accompanied by tinnitus – ringing in the ears – and dizziness.   All of the reports involved the loss of hearing in one ear, and in two thirds of the cases the hearing loss was permanent.

This is the second time that the Viagra, Levitra and Cialis labels were modified due to a serious side effect. In 2005, the labels were changed to include warnings about vision loss associated with the drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

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

UAB study links vision loss with Viagra, Cialis use

Tue, 17 Jan 2006 00:00:00 -0800

A study from the University of Alabama at Birmingham indicates men with a history of heart attack who use the erectile dysfunction medications Viagra or Cialis may be at increased risk for vision loss.

The study, published in the British Journal of Ophthalmology, indicates a link between use of the medications and non-arteritic anterior ischaemic optic neuropathy (NAION), a condition affecting up to 6,000 people each year in the United States.

The condition, described as a "stroke of the eye," can cause vision loss in one or both eyes. It is caused by insufficient blood flow to the optic nerve head, damaging the nerve and leading to permanent vision loss.

Gerald McGwin, an associate professor of epidemiology and ophthalmology at UAB and the lead author of the study, says his team's research uncovered a "strong link" between the medications and NAION incidents in men with a history of heart attack.

"We found similar results in men with hypertension which, while not as dramatic, are substantial enough to indicate that men with a history of either heart attack or hypertension should be warned of the risks of NAION before use of these medications," McGwin said.

He notes this is the first study to investigate the association since the U.S. Food and Drug Administration suggested in 2005 a link might exist.

The drug Levitra did not appear on the market until after the study began, so it is not included in the findings.

The study was funded by Research to Prevent Blindness Inc., and the Eyesight Foundation of Alabama.

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.

Health Canada Issues Advisory Concerning Vision Problems Possibly Associated with Viagra, Cialis, and Levitra

Wed, 27 Jul 2005 00:00:00 -0700

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

All of this began on May 27, when the FDA disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra).

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.

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.

The new labeling information is available along with additional information for healthcare providers and consumers online at:

Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)
The Advisory from Health Canada follows:

“Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.
The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible.

Risk factors for NAION include:

•   age greater than 50 years
•   heart disease
•   high blood pressure
•   high cholesterol
•   diabetes
•   smoking
•   certain pre-existing eye problems

An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.

Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer AG/GlaxoSmithKline (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.

While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.”

Health Canada Advises About Vision Problems Possibly Associated With Viagra, Cialis and Levitra

Tue, 26 Jul 2005 00:00:00 -0700

Health Canada is advising individuals who use the drugs Viagra, Cialis and Levitra to consult their physicians and seek immediate medical attention if they experience sudden vision loss or vision-related problems while taking these drugs. Viagra, Cialis and Levitra are drugs used to treat impotence and erectile dysfunction in men.

The specific type of vision loss, called nonarteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic nerve is blocked. It causes sudden and painless loss of vision in one or both eyes. Those who experience one episode are at a greater risk of experiencing a second episode affecting the other eye. Vision loss may be partial or complete. While in some cases the condition may improve over time, it can also be irreversible. Risk factors for NAION include:

    * age greater than 50 years
    * heart disease
    * high blood pressure
    * high cholesterol
    * diabetes
    * smoking
    * certain pre-existing eye problems

An article in the March 2005 issue of the Journal of Neuro-Ophthalmology discussed 14 cases of NAION that occurred in patients using Viagra. All these patients had other risk factors for NAION, including high blood pressure, high cholesterol or diabetes. Health Canada is currently reviewing two Canadian reports of vision problems in patients using Viagra that may be consistent with NAION, but it has not yet been confirmed that these problems are related to the use of the medications above. It is difficult to determine whether the use of Viagra, Cialis or Levitra is causing NAION, as individuals who have erectile problems often have high blood pressure, diabetes or other conditions that put them at increased risk.

Health Canada continues to monitor these drugs and has requested additional safety information from all three manufacturers - Pfizer (Viagra), Eli Lilly (Cialis), and Bayer Inc. (Levitra). Changes to the product information for health care professionals and patients are anticipated, and the information will be communicated to the public after all the safety data has been thoroughly assessed.

While Health Canada's assessment of the safety data on this issue continues, the Department is advising Canadians of this information now to address any concerns.

FDA Orders Warning Label on Viagra

Sat, 09 Jul 2005 00:00:00 -0700

The government on Friday ordered warnings onto the labels of Viagra and two other impotence drugs after some users developed a form of blindness. The Food and Drug Administration's move comes as the agency is under intense pressure to investigate 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.

Cialis is marketed by Eli Lilly & Co. and ICOS Corp. Levitra is sold by GlaxoSmithKline PLC and Schering-Plough Corp. in the United States, and by Bayer AG elsewhere.

FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems Possibly Associated with These Drugs

Sat, 09 Jul 2005 00:00:00 -0700

The Food and Drug Administration (FDA) has approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

The FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away 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 states 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.

The new labeling information is available along with additional information for healthcare providers and consumers online at:

Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)
Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)
Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)

FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing Reports of Eye Problems

Fri, 08 Jul 2005 00:00:00 -0700

The Food and Drug Administration today approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

FDA advises patients to stop taking these medicines, and call a doctor or healthcare provider right away 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.

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 new labeling information is available along with additional information for healthcare providers and consumers online at:

Viagra (http://www.fda.gov/cder/consumerinfo/viagra/vIAGRA.htm)

Levitra (http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm)

Cialis (http://www.fda.gov/cder/drug/infopage/cialis/default.htm)

FDA Was Told of Viagra-Blindness Link Months Ago

Fri, 01 Jul 2005 00:00:00 -0700

More than 13 months before a scientific journal reported that Viagra had been linked to a rare form of blindness in some men, a Food and Drug Administration safety officer made the same observation from monitoring adverse event reports and told her supervisors that doctors and patients should be warned of the findings.

Her recommendation was well received, she told congressional investigators, but nothing happened. The FDA issued no public notice or proposed changes to the Viagra label. That came only following widespread publicity last month about the journal article and public concerns about the possible blindness-Viagra link.

The safety officer's experience was outlined in a letter last week to FDA Acting Commissioner Lester M. Crawford from Sen. Charles E. Grassley (R-Iowa), who said the agency had moved far too slowly on an emerging safety concern.

Criticism of the FDA's response to potentially harmful drug side effects has been frequent and sharp since Merck & Co. took its popular arthritis painkiller, Vioxx, off the market last fall after studies indicated that it increased the risk of heart attacks and strokes. The FDA has sought to tighten its drug safety oversight since then, but some critics say the agency is doing too little and still puts more emphasis on reviewing and approving new drugs than on safety concerns.

"I am troubled by the FDA's action, or lack thereof, relating to the updating of Viagra's product label," Grassley wrote. He said the agency's Office of New Drugs (OND) had done nothing "despite OND's knowledge of the blindness risks since January 2004 and general agreement among FDA staff last spring that the label should be updated."

Grassley also wrote that the safety officer, whose name was not disclosed, explained the agency's inaction by saying the Office of New Drugs "is under such time pressure to approve new drugs, often safety concerns needed to be 'fit in' where they could."

"What we appear to have here, Dr. Crawford, is yet another example of the 'separate but unequal' relationship" between the Office of New Drugs and the Office of Drug Safety, Grassley wrote.

Researchers remain uncertain whether Viagra and other impotence drugs pose a significant risk of blindness. Pfizer Inc., which makes the drug, says the side effect has not appeared in any of its 103 clinical trials of Viagra involving 13,000 patients and that the 23 million users have not reported an increased risk of blindness.

Late last month, however, after the possible link was reported in the Journal of Neuro-Ophthalmology, FDA spokeswoman Susan Cruzan said, "We take this seriously, and the FDA is working with the sponsors to make sure the public is aware of this so they can take it into consideration." The journal study examined seven cases where men suffered an unusual form of sudden blindness within 36 hours of taking Viagra.

On Monday, Pfizer said in a statement that it does not believe there is a causal relationship between Viagra and blindness but that it will add information about the possibility to its label. The company said the FDA had asked the makers of all impotence drugs to do the same.

"There is no evidence that Viagra causes blindness or any other serious ocular condition," said Joseph Feczko, Pfizer's chief medical officer. "Men taking Viagra are at no greater risk for blindness than men of similar age and health not taking the medicine."

In all, the FDA has said, 38 Viagra users and five users of other impotence drugs reported a sudden and permanent blindness in one eye called non-arteritic anterior ischemic optic neuropathy, or NAION. In a report Monday, CBS News said that the number is much higher, and that more than 800 patients and doctors have reported eye problems to the FDA after using Viagra over the past four years, with more than 140 cases of partial or total blindness. While these "adverse event" reports do not prove a causal link between the drugs and sudden blindness, drug safety experts look to them for trends and patterns.

This form of sudden blindness is caused by the blockage of blood flow to the optic nerve and is most common in older people, who disproportionately use Viagra. An estimated 1,000 to 6,000 Americans suffer an optic blockage each year.

Grassley's letter said the FDA safety officer first brought her concerns to the Office of New Drugs in January 2004. That was followed by a more formal draft safety "consult" in March 2004 and a final report the next month.

The letter paraphrases internal FDA documents as saying that Pfizer "resisted the FDA's initial request to update the Viagra label to include information about the NAION risks." Pfizer spokesman Mariann Caprino said the company does not comment on its interactions with the FDA. Earlier, another Pfizer spokesman said the company contacted the FDA about the blindness cases in March, after the journal report was published.

Grassley's letter also questions whether the FDA's adverse event reporting system would be capable of detecting NAION cases that might be associated with Viagra. Until now, it said, few doctors who prescribe Viagra would know to ask patients about vision problems, and few ophthalmologists who treat sudden blindness would know to ask about Viagra use. FDA officials said they had no comment on Grassley's letter.

All three impotence drugs on the market, Viagra, Cialis and Levitra, already warn users that the drug can cause minor vision changes that include blurring, sensitivity to light and the presence of a bluish hue. The makers of Cialis, Eli Lilly & Co. and Icos Corp., have voluntarily added a notice about the risk of sudden blindness to their label.

LAWSUIT ALLEGING BLINDNESS FROM TAKING VIAGRA IS FILED IN TEXAS FEDERAL COURT

Fri, 10 Jun 2005 00:00:00 -0700

A federal lawsuit filed by James Thompson in the United States District Court for the Southern District of Texas seeks monetary damages for the loss of vision allegedly caused by the use of Viagra, Pfizers blockbuster erectile dysfunction (ED) drug. Mr. Thompson also seeks class- action certification on behalf of all other men injured by the drug.

The Food and Drug Administration has received over 40 reports of blindness in men taking Viagra, Levitra, or Cialis. This type of irreversible blindness known as non-arteritic anterior ischemic optic neuropathy (NAION) restricts the flow of oxygenated blood to the optic nerve.

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.

The lawsuit charges that Pfizer failed to warn the public that taking Viagra could cause NAION.

Parker & Waichman, LLP Contacted by Viagra, Cialis & Levitra Users Claiming Vision Problems, Blindness & Other Side Effects; Firm to File Lawsuits in Coming Weeks

Fri, 03 Jun 2005 00:00:00 -0700

Drug side effects lawyer receiving hundrends of inquiries from Viagra, Cialis and Levitra users that claim to have impaired vision or complete vision loss (blindness) after using these drugs. The FDA is evaluating erectilie dysfunction drugs link to NAION.

For the past 6 months, Parker & Waichman, LLP (www.yourlawyer.com) has been contacted by prospective clients who claim to have suffered loss of vision as a result of using the erectile dysfunction drug Viagra (sildenafil citrate). Last week, the FDA announced that it is investigating a link between erectile dysfunction drugs and NAION - nonarteritic anterior ischemic optic neuropathy - which can cause blindness. Parker & Waichman, LLP has also received a significant number of inquiries from Cialis and Levitra users who claim to have suffered vision loss after using those drugs. Viagra, Cialis and Levitra patients can learn more by visiting http://www.yourlawyer.com/practice/overview.htm?topic=Viagra.

In its announcement last week, The Food and Drug Administration said it had received 43 reports of varying degrees of vision loss, including blindness, among users of erectile dysfunction drugs. There were 38 reports of blindness among Viagra users (Six patients had vision loss within 24 hours after use of Viagra), four among Cialis users and one among Levitra users. Eli Lilly & Co. (NYSE: LLY) and ICOS Corp. (NASDAQ: ICOS), the makers of Cialis, have already added a warning about possible vision loss to the drug’s label. The FDA has said it is in discussions with Pfizer Inc. (NYSE: PFE) the maker of Viagra, and the makers of Levitra, Bayer AG (NYSE: BAY), GlaxoSmithKline PLC (NYSE: GSK) and Schering Plough CP (NYSE: SGP) about warnings on those drugs’ labels. Over 30 million men worldwide have used an erectile dysfunction drug since Viagra came onto the market in 1998.

NAION occurs when blood flow to the optic nerve is blocked. NAION can be temporary, but it is usually permanent and often leads to legal blindness. Parker & Waichman, LLP continues to offer free case consultations to Viagra, Levitra and Cialis users and their families. Patients can click the appropriate link below for a free consultation:

Viagra Patient Case Consultation: http://www.yourlawyer.com/practice/overview.htm?topic=Viagra

Cialis Patient Case Consultation:
http://www.yourlawyer.com/practice/overview.htm?topic=Cialis

Levitra Patient Case Consultation: http://www.yourlawyer.com/practice/overview.htm?topic=Levitra

For more information on Parker & Waichman, LLP please visit: (http://www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).

Contact:
Parker & Waichman, LLP
David Krangle, Esq.
(800) LAW-INFO (800-529-4636) (toll free)
http://www.yourlawyer.com

Viagra Linked to Vision Problems FDA Studies Reports, Discusses Disclosure

Sat, 28 May 2005 00:00:00 -0700

An investigation into whether Viagra and other popular impotence drugs may cause permanent eye damage is unlikely to lead to a recall, federal officials and medical experts said Friday, but could prompt new warnings.

The Food and Drug Administration is looking into 38 reports of eye damage in men who took Viagra, four involving Cialis, and one with Levitra. About 30 million men worldwide have taken the drugs.

"We haven't been able to determine that there is a cause and effect due to the medication," FDA spokeswoman Suzanne Trevino said. "But we are taking it seriously."

Most of the men who suffered eye damage did not go completely blind but lost part of their vision in one eye. Complicating the FDA's investigation, many of the patients had other risk factors, such as high blood pressure, that would make them vulnerable to the particular kind of eye problem.

The condition nonarteritic anterior ischemic optic neuropathy, or NAION involves damage to the optic nerve caused by an interruption of blood supply.

Trevino said the FDA is talking with Pfizer Inc., Viagra's manufacturer, about formally disclosing the risk in its prescribing literature for doctors. Eli Lilly & Co., which makes Cialis, recently changed its information to acknowledge reports of eye damage.

Dr. Howard Pomeranz, a professor of ophthalmology at the University of Minnesota, reported a suspected link between Viagra and eye damage in a medical journal article published in March.

"This particular eye problem should be added to the list of side effects that patients have access to," Pomeranz said Friday. But, he added, the medical evidence at this point would not warrant withdrawing the drug.

"I'm not recommending that men stop taking this drug," he said. "It's very good for what it's prescribed for."

However, Pomeranz said, patients who already have NAION in one eye should be strongly cautioned about the risk of using Viagra. And any patient who experiences blurriness or a loss of peripheral vision should stop taking such medications and consult a doctor immediately.

For patients who want to know whether they may be at risk, an eye exam may help answer the question. Doctors say one risk factor for NAION is tightly bundled nerves and blood vessels in the back of the eye. An eye doctor can identify that condition.

Medical factors that increase the risk of NAION include high blood pressure, high cholesterol and diabetes. Older people also are more likely to have the problem.

Dr. Michael Lee, a neuro-ophthalmologist at the Cleveland Clinic Foundation, treated a 67-year-old architect who had received a sample pack of Cialis from his primary care doctor.

One morning, two hours after taking the drug, the patient noticed a blurry patch in the bottom of his field of vision in his right eye, Lee said. His vision recovered by the next morning.

The patient took the drug three more times, with the same effect. Then he took another dose. That time, the blurry patch did not go away. The damage was permanent, Lee said.

The patient had two risk factors for NAION: high cholesterol and an especially small channel for blood vessels that run through the optic nerve behind the eye.

NAION strikes fewer than 10 people out of every 100,000 over age 50, Lee said.

In a statement, Pfizer said there was no evidence that NAION occurred more frequently in men taking Viagra than in men of similar age and health who did not take the drug.

"Most of the reported cases in which NAION has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors," the company said. "This makes it impossible to determine whether these events are caused by the patient's underlying risk factors, anatomical defects, Viagra, or a combinations of these factors."

Eli Lilly spokeswoman Kindra Strupp said the company has updated its prescribing literature to reflect the reports of NAION. But "we don't see any cause-and-effect link," she added. "It certainly has not been established at this point."

Pomeranz said he disagreed with the drug companies' assertion that any association between the medications and eye damage was coincidental. In the 20 or so cases he reviewed, the onset of eye problems followed the patient's taking of Viagra -- usually by several hours, but sometimes by as few as 45 minutes.

"It's really the time connection between when the patient took the drug and when he noticed the loss of vision that convinces me there's a link," Pomeranz said.

His medical journal article conceded that "a definite causal relationship cannot be established at this time." But in view of the ever-growing use of such drugs, he wrote, the FDA must investigate.

"It is critical that irreversible ocular side effects such as NAION be ruled out in this class of drugs," he wrote.

The situation presents a common dilemma for the FDA: Although drugs may be tested on several thousand people before their approval, rare side effects may not emerge until many more have used the medication.

Some doctors said Friday that patients inquiring about the potential risk of eye damage were not overly alarmed.

"It's way out of proportion," said Dr. Steven Schwartz, chief of the retina division at the Jules Stein Eye Institute at UCLA. He sent three cases to the FDA, but as in the other reports received by the agency, the patients had other risk factors for NAION.

Side effects

Federal health officials are examining rare reports of blindness among some men using Viagra and Cialis. The warning labels of both impotence drugs, as well as Levitra, currently list the following side effects, according to the drugs' Web sites:

Viagra: "Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light or blurred vision."

Cialis: The drug "may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green."

Levitra: The drug "may uncommonly cause vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green."

FDA Investigating Possible Link Between Vision Loss And Viagra

Sat, 28 May 2005 00:00:00 -0700

The Food and Drug Administration is investigating whether impotence drugs such as Viagra and Cialis are linked to blindness and partial vision loss in some men, the agency announced Friday.

The FDA said it has 43 reports of such problems, including seven from a University of Minnesota ophthalmologist.

The federal agency cautioned that there is no evidence that the drugs cause the problem, and that the reports of it among men taking the drugs are exceedingly rare. About 30 million men around the world have used the drugs since Viagra was first introduced in 1998.

But Dr. Howard Pomeranz, the university researcher and associate professor, said that he thinks the drugs are suspect because vision loss in six patients occurred within 24 hours of taking the drug. And it might happen more often than anyone knows, he said. Men who suffer the vision problem, which results from blood loss to the optic nerve, may not volunteer that they are taking drugs for impotence, he said.

"I think the investigation is worthwhile," Pomeranz said Friday. And anyone taking the drugs "owe themselves a visit to their eye doctor to see if they have any risk," he said.

Another bad turn

The disclosure comes at a time when the drug industry is already reeling from reports of harm from other blockbuster drugs, including Vioxx and Celebrex, and the FDA has been criticized for not acting fast enough to make newly discovered risks public.

Viagra is one of the biggest selling drugs made by Pfizer Inc., with nearly $1 billion in sales last year. In all, the three largest selling impotence drugs generated more than $1.3 billion in sales last year, according to the drug tracking firm IMS Health.

Pfizer said in a statement Friday that it is in discussion with the FDA about adding a warning to Viagra's label. Cialis, which is made by Eli Lilly & Co. and ICOS Corp., has already done so voluntarily.

The FDA said that 38 of the eye-problem cases are related to Viagra, four cases are linked Cialis, the second largest selling drug, and one case was linked to Levitra, the third largest, said FDA spokesperson Susan Cruzan.

The drugs carry other risks. They should not be used by men with heart conditions or who take nitrate drugs, which can cause a dangerous drop in blood pressure.

And labels on all three drugs already warn about possible eyesight problems, including increased sensitivity to light, blurred vision, and trouble distinguishing blue from green.

Permanent damage

This eye problem is different. Pomeranz said that the loss of vision, which can be complete and is always permanent, occurs when the tiny bundle of arteries that feed the optic nerve do not get enough blood.

It's called non-arteritic anterior ischemic optic neuropathy (NAION), also known as a "stroke of the eye." There could be a connection to the drugs, he said, because they affect blood flow and reduce blood pressure, he said.

The FDA and Pfizer said the eye condition commonly occurs in older men, who are the most common users of the impotence drugs. Some of the risk factors for erectile dysfunction high blood pressure, high cholesterol, and diabetes also put men at risk of a stroke of the eye, the company said.

Pomeranz said that he first saw a link in 1998 when a patient told him his vision loss occurred less than hour after taking Viagra. Pomeranz began looking for similar cases.

In March he published a study describing seven patients seen at the University of Minnesota. All of them were between 50 and 69 years old, had high blood pressure, high cholesterol or diabetes.

Some had taken Viagra for some time before the vision loss occurred. All but one experienced vision loss within 24 hours of taking an impotence drug.

Pomeranz recommended in the March issue of the journal Neuro-Opthalmology that eye doctors should ask all men who develop this kind of vision impairment whether they take impotence drugs.

FDA MAY REQUIRE WARNING THAT IMPOTENCE MEDICATIONS MAY CAUSE BLINDNESS

Sat, 28 May 2005 00:00:00 -0700

For the past seven years, the jubilation surrounding the availability of drugs like Viagra, Cialis, and Levitra has been remarkable. No other drugs since oral contraceptives have had such a dramatic impact on sexual practices and expectations. As with every other powerful prescription drug, however, the day of reckoning regarding potentially dangerous side-effects was always lurking in the shadows. That day has now arrived.

The FDA has disclosed that, since 1998, it has received some 43 reports of non-arteritic anterior ischemic optic neuropathy (NAION), a type of blindness, in men taking impotence drugs (38 involving Viagra, 4 for Cialis, and 1 for Levitra). 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 is enough to raise the issue of whether the FDA should require a warning these drugs to carry a warning with respect to NAION. Pfizer (Viagra) is considering a label change while Eli Lilly (Cialis) has already added a reference to the reports of NAION. GlaxoSmithKline (Levitra) has not made any public Statement on the matter. .

Personal Injury & Side Effects News

FDA Looking Into Blindness-Viagra Link

Fri, 27 May 2005 00:00:00 -0700

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.

FDA is working with Viagra manufacturer Pfizer Inc. to determine what, if any, information about the condition should be added to the drug's label.

FDA Probing Possible Link Between Viagra, Blindness

Fri, 27 May 2005 00:00:00 -0700

Shares of Pfizer, maker of the impotence drug Viagra, sank today after federal health officials said they were investigating a relatively small number of cases in which men taking Viagra and similar drugs reported suffering from blindness or partial vision loss.

The Food and Drug Administration has received 38 reports of blindness from Viagra users and four from those taking Cialis, said FDA spokeswoman Susan Cruzan.

The agency emphasized that the reports amount to a tiny fraction of the people taking the drugs, and that the blindness might have been triggered by other health problems. An estimated 23 million people have used Viagra, according to the manufacturer.

The vision problems "also occur in people who have never taken Viagra," Cruzan said. "We will continue to evaluate [the reports] but we can say that the drug is safe and effective as labeled."

Reports of blindness and the FDA's investigation, first reported by CBS News on Thursday, sent shares of Pfizer lower on Wall Street today. Viagra shares were down more than 2% in afternoon trading on the New York Stock Exchange.

Shares of Eli Lilly, which makes Cialis in partnership with another company, were virtually unchanged. The stock of GlaxoSmithKline, which sells Levitra domestically, were up slightly.

Viagra is a blockbuster product for New York-based Pfizer and is the best-selling drug to treat erectile dysfunction. The drug generated $438 million in revenue for the company during the first quarter of the year.

Pfizer spokesman Daniel Watts told Associated Press that the company was talking to the FDA about changing the Viagra label to include information about the few cases of vision damage reported by users. However, Watts said that there is no proof that Viagra caused the blindness, and that many of the men taking the drug also suffered from other conditions such as high blood pressure and high cholesterol that can also lead to blindness.

Indianapolis-based Eli Lilly had no immediate comment.

US Probes Viagra 'Blindness Risk'

Fri, 27 May 2005 00:00:00 -0700

US health officials are examining reports of varying degrees of blindness among a small number of men using the anti-impotence drug Viagra.

The Food and Drug Administration (FDA) has identified 50 cases of the condition, which can occur in men with heart disease or diabetes.

The FDA says it has as yet found no evidence that Viagra is to blame for the condition.

More than 20 million men worldwide have used the drug since its launch in 1998.

A spokesman for Pfizer, the makers of the drug, said the company was considering changing its warning on the drug label.

"We are in discussions with the FDA to update our language to reflect these rare ocular events that have occurred," said Daniel Watts.

He said that men who took Viagra often already had those types of diseases that could cause blindness.

Simple test

There have been no reports of the condition among 13,000 people tested in clinical trials for the drug.

The condition, known as nonarteritic anterior ischemic optic neuropathy (NAION), causes a rapid reduction of vision and can, in the most serious cases, lead to blindness.

Dr Howard Pomeranz, co-author of a report on the condition published in the Journal of Neuro-ophthalmology in April, said the drug had long been linked to sight problems.

Viagra was known to cause temporary colour changes in some men's vision, he said, but NAION was a much more serious condition.

Dr Pomeranz said the problem may have been underreported as most people would not think to mention to their ophthalmologist that they were taking the drug.

"When patients see their ophthalmologist at the time they are examined for loss of vision how many of them would think to bring up the fact that they are using a drug like this to an eye doctor?"

He said men could avoid the condition by undergoing a simple screening test.

Dr June Raine, of the UK Medicines and Healthcare products Regulatory Agency, said it had only received six reports of adverse reactions to Viagra resulting in blindness, including four of optic neuropathy.

In contrast, about 900,000 patients had been prescribed Viagra in the UK.

Dr Raine said the issue had been kept under review by European regulators, but as yet there was no firm evidence that Viagra caused eye problems.

"Anyone who has concerns about their eyesight should speak to their doctor.

Viagra Possibly Linked to Blindness

Fri, 27 May 2005 00:00:00 -0700

COOPER: There's a disturbing new report out tonight about a possible devastating side effect of popular impotence drugs like Viagra and Cialis. The U.S. Food and Drug Administration is investigating whether the drugs cause a rare form of blindness. Already, the government is looking into reports that 38 users of Viagra suffered permanent vision loss. To put that in perspective, 28 million men take these drugs, so 38 is a relatively small number, but alarming nevertheless. 360 MD Dr. Sanjay Gupta is following the story, joins us from Atlanta with the latest Sanjay.

SANJAY GUPTA, CNN SR. MEDICAL CORRESPONDENT: Anderson, yeah, the numbers are very small, that's the first thing to point out here; 38 Viagra users, also four Cialis users and one user of Levitra having these sorts of problems.

Important to put this in context a little bit. There has been some known visual problems with Viagra in the past. Not blindness per se, but difficulties with colors. Actually, seeing bluish and greenish hues after use of this particular medication. So there is a little bit of a history there.

But now what we're specifically talking about is a sort of stroke-like thing in the back of the eye. That's the optic nerve there. Those are some of the blood vessels actually turning dark. That's what happens in this particular condition, and what is causing a permanent sort of visual problem here.

We're talking about all of the various drugs for erectile dysfunction, again, Viagra, Levitra and Cialis. If you look at that, again you see the animation there, but what's important to point out is that this is just an association. No one yet, Anderson is drawing an exact link between any of these medications and blindness. They're saying they're seeing this in small numbers. They're investigating a little bit further right now, Anderson.

COOPER: All right. I want to listen to what the Pfizer Vice President Michael Berelowitz had to say about the reported problems linked to his drug, to Viagra. Let's listen.

MICHAEL BERELOWITZ, PFIZER: We've looked in 103 studies at 13,000 patients. And basically remembering, these are the patients who have erectile dysfunction. These are people who have erectile dysfunction by the very people who will be taking this treatment, and we did not see any cases, we did not see any cases of NAION in those studies.

COOPER: I mean, he seems to be inferring there's absolutely no connection. What have these studies found?

GUPTA: You know, it's interesting, Anderson. I have talked to the researchers who actually conducted these studies in detail about this. What you will find, first of all, interestingly, is if you look at this sort of stroke condition of the eye, it exists in the general population among people who have never taken one of these medications. That's worth pointing out.

But in the people who did take the medications, what got everyone's antenna sort of up was the timing association. Meaning, they take the medication, then they'd have a visual problem. They wouldn't take the medication, they didn't have a visual problem. Then they would take it again, and the visual problem would come back. So it was that timing that sort of got everyone sort of concerned.

Again, it's an association at this point. They haven't proven that it actually causes this, but they do say that the same people who are most likely to be taking these drugs, Viagra, Cialis and Levitra, are also the same people who are more likely to just have these strokes in the first place. So it's hard to figure out what's causing what here, Anderson.

COOPER: So a patient comes to you and says, should I stop taking these? Should I keep taking them? What do you tell them?

GUPTA: Well, first of all, you know, there's no direct link now between the drugs and the blindness. So you can't say for sure to stop taking these medications. If you've ever had a problem with your eyes in the past, if you are at high risk because of high cholesterol, high blood pressure, diabetes, history of smoking, things like that, then you could be at higher risk for stroke. Then it's probably worth talking to your doctors about. Numbers are very small, Anderson. Most of the people watching today, they will never have this happen to them.

COOPER: All right. Dr. Sanjay Gupta, appreciate it.

Can Viagra Cause Blindness?

Fri, 27 May 2005 00:00:00 -0700

AARON BROWN, CNN ANCHOR: Good evening again. If you've ever seen a prescription drug commercial, in other words, if your television works at all, you've gotten to know the fast talking guy, the one that tells you about the dizziness, fainting spells and dry mouth. Today the Food and Drug Administration said it wants to give him one more thing to mention maybe. It is asking the maker of Viagra to update its warning label to mention vision loss.

So far the numbers are tiny and the connection not fully explored, but given how many people who use Viagra and drugs like it to treat impotence of just for the thrill, nobody's taking any chances. So, we begin tonight with Dr. Sanjay Gupta.

DR. SANJAY GUPTA, CNN SENIOR MEDICAL CORRESPONDENT (voice-over): The concern isn't new. It has been known for years that users of Viagra could experience short term vision changes, seeing green or bluish hues.

MICHAEL BERELOWITZ, VP WORLDWIDE MEDICAL, PFIZER: The first reports we were aware of was in 2000. More cases were published in the literature in March of this year.

GUPTA: The numbers are small, extraordinarily small, only 38 Viagra users of the more than 20 million who take it have come forward with vision problems. There have also been four users of Cialis and one with Levitra with similar problems, the pills manufacturers say.

They say the vision loss is caused by a sort of stroke affecting the blood vessels of the eye. That stroke in the back of the eye occurs when the blood vessels become choked off, eventually causing some of the cells in the eye to die.

Interestingly, the number of people who get the same type of stroke is actually about four times higher for people who don't take Viagra, the study's researchers say. But it's the relationship of timing between someone taking the drug and then within a short time getting visual problems that raised the red flags.

DR. HOWARD POMERANZ, UNIVERSITY OF MINNESOTA: Well, this patient that I just described from 1998 noticed the effect within 45 minutes after using the drug. Most of these patients experience this within hours.

GUPTA: And what Dr. Pomeranz who published the research showing the association noticed was not complete blindness, but things like loss of peripheral vision or a worsening of vision, for example, going from 20/20 to 20/40.

The truth is, It may be difficult to ever show a link between these medications and vision problems. That's because the same problems who get the stroke in the back of the eye are those with high cholesterol, high blood pressure, diabetes and a history of smoking. They're also more likely to have erectile dysfunction and take a medication like Viagra.

BERELOWITZ: You have the same group of patients with the same characteristics who might be at risk for this very, very infrequent condition that affect the eyes.

GUPTA: Still, if you happen to be one who actually reads those package inserts, you won't find reference to visual loss in there. But Pfizer is talking to the FDA about whether to add it.

Still worried?

POMERANZ: Well, I think there's some concern, but I don't think that everyone needs to go running in panic to their doctors.

GUPTA: And certainly, if you ever had a visual problem after taking Viagra, Levitra or Cialis talk to your doctor about getting your eyes checked.

Dr. Sanjay Gupta, CNN, reporting.

BROWN: Flesh out a bit more on the science and the medicine behind the concerns here with Viagra and the other drugs, we spoke earlier tonight with Dr. Pomeranz again.

BROWN: Do you know what it is about the drug that causes this problem when the problem is caused?

POMERANZ: Well, I only have a hypothesis. I don't have a certain answer. But I think it has something to do with what the drug may cause in terms of circulatory changes to the optic nerve.

BROWN: Did anyone go completely blind forever?

POMERANZ: Well, it depends what you mean by blind.

BROWN: Can't see.

POMERANZ: Yes.

BROWN: Forever.

POMERANZ: Yes. The patients in these studies that I reported all have permanent vision loss. This isn't a temporary transient color change that patients get for a few minutes or an hour that goes away. This is permanent damage that occurs to the eye.

BROWN: So you're talking about someone who could see yesterday and can't see anything, essentially anything.

POMERANZ: Correct. It could be a loss of eye chart vision, instead of being 20/20, they might be 20/50, 20/200. Or they may have peripheral visions. They might still have 20/20, but have lost half of all their peripheral vision.

BROWN: OK. I think when I say blind, I mean I'm not trying to be cute here, I mean like Ray Charles, blind. You can't see anything.

POMERANZ: No, I don't think that applies to people here in the study. Maybe one of the patients out of this most recent study that came out had really poor vision, meaning they could barely see light or maybe a hand moving in front of them. But that was maybe one patient out of the seven. The rest of them had vision that was much better than that.

BROWN: One of the things that the piece that precedes this conversation says, and that Pfizer says, is that the people that there's a certain predisposition that they have hypertension, or they are smokers or they're overweight. But what I hear you saying is that actually it's not quite that simple. That you might be perfectly healthy in all respects, nonsmoking but you have this thing in your eye that makes it vulnerable.

POMERANZ: Correct.

BROWN: Is that can you check that?

POMERANZ: Yes, by looking through the pupil into the back of the eye, you can look at the optic nerve and see if the optic nerve has this structure.

BROWN: Is the incidents of this enough so that doctors prescribing it ought to send a patient to you or someone like you first to look in the back of their eye and see what's going on?

POMERANZ: Well, it is kind of difficult to answer that question. The number of people who probably have this particular structure of the optic nerve is very small to begin with, if you just took a cross section of the population. So you'd be screening a lot of people to find people who have this particular nerve configuration.

I've actually thought about this issue myself and debated is it worth saying screen everybody. But I think you'd be looking at hundreds of thousands of people to find a few people who would fit that category. So, I'm not sure that's the most efficient way to do it.

BROWN: How long does the test take?

POMERANZ: You can pick up an ophthalmoscope and look at the back of the eye, less than a minute.
BROWN: So, in that sense. I presume that before you before someone prescribes Viagra, they check their blood pressure and probably check other things.

POMERANZ: Assuming they get it from a legitimate means.

BROWN: It takes at least as long as a minute to look in their eye.

POMERANZ: Sure. So yes, an internist or family physician could pick up their ophthalmoscope and look at the back of eye and see if they have this small cupdisperatio (ph).

BROWN: Last question. Are you surprised at the flurry of attention that the study has received today?

POMERANZ: Well, it kind of started as a trickle. And it suddenly turned into an avalanche that's kind of overwhelmed me all day long. It has kind of been an interesting experience, to say the least.

BROWN: I'll bet it has. Nice to meet you.

POMERANZ: Thank you very much.

BROWN: Have a great holiday weekend.

POMERANZ: Thank you. You too.

BROWN: Thank you.

Viagra Causes Blindness in Small Percentage of Users

Fri, 27 May 2005 00:00:00 -0700

O'BRIEN: Well, you can almost hear the late night monologues writing themselves, but the FDA says it is serious about investigating more than three dozen reports of blindness among users of Viagra and some other wildly popular erectile dysfunction drugs, 43 to be precise, out of the millions of men who have used those drugs since '98.

Details now from CNN medical correspondent, Christy Feig.

CHRISTY FEIG, CNN CORRESPONDENT: The FDA says they are investigating about 38 cases of blindness in men taking Viagra. This type of blindness is called nonarteritic anterior ischemic optic neuropathy. It's basically a stroke of the eye. The blood flow is cut off to the optic nerve, injuring the nerve and causing permanent vision loss.

Researchers from the University of Minnesota say in 14 cases they've seen, the men were between the ages of 50 and 69 years old. And almost all of them had health problems like high blood pressure, diabetes, high cholesterol or a history of smoking.

In those cases the men lost either the central part of their vision or their peripheral vision. It was not total vision loss, but it was permanent.

Pfizer, the maker of Viagra, released a statement saying, "There is no evidence that NAION occurred more frequently in men taking Viagra than in men of similar age and health of men who did not take Viagra."

In an FDA statement, they say, "Viagra is safe and effective as labeled. There are no changes to the overall risk-benefit profile. Patients should talk to their doctor about using the drug and whether the drug is right for them."

There are two other impotence drugs on the market, Cialis and Levitra. The makers of Cialis say they have had four cases of NAION and have already changed their labels. The makers of Levitra have reported one case.

Christy Feig, CNN, Washington.

Viagra Link To Cases of Blindness

Fri, 01 Apr 2005 00:00:00 -0800

Men who use Viagra may put themselves at risk of permanent blindness, experts warn.

Researchers say there have been 14 known cases in which men have suffered a 'stroke of the eye' shortly after taking the drug used to cure impotence.

A stroke of the eye occurs when the blood flow to the optic nerve is cut off, leading to irreversible loss of vision. Experts at the University of Minnesota Medical School in the U.S. said the number of cases supported the belief that there may be a causal link between Viagra and the condition.

Lead researcher Professor Howard Pomeranz said that all men who have suffered a stroke of the eye also known as nonarteritic ischemic optic neuropathy, or NAION should be asked about use of Viagra so that any link can be more firmly established.

Vision loss

He added: "For years, we've known that some men who take Viagra will experience temporary colour changes in their vision and see things as blue or green. But this stroke of the eye is a much more serious condition because it can lead to permanent vision loss."

Viagra has been used by more than 23million men since it was launched in 1998.

It works by inhibiting a natural enzyme in the body which helps to regulate blood flow. But Professor Pomeranz warns that the way in which it functions could have other unwanted and potentially dangerous effects elsewhere in the body.

Damage the blood vessels

He said: "Viagra regulates a chemicalin the body to constrict the arteries. This constriction may cut off the blood flow to the optic nerve where the blood vessels and nerves are tightly bundled provoking NAION."

The researchers, writing in the journal Neuro-ophthalmology, gave details of seven men, aged between 50 and 69, who showed features of stroke of the eye within 36 hours of taking Viagra. They said seven similar cases have been reported.

Professor Pomeranz said patients who have suffered NAION in one eye should be warned that taking Viagra may increase the risk of suffering the condition in the other eye.

All the patients studied had at least one risk factor for narrowing of the arteries such as high blood pressure or diabetes.

Past research shows that in more than 70 per cent of cases of erectile dysfunction there is an underlying condition such as these which can damage the blood vessels involved in sexual intercourse.

There have been persistent fears that Viagra might be dangerous in men already at risk of heart attack and stroke, but clinical trials have found no actual evidence.

U of M Researcher Says Viagra May Cause Permanent Vision Loss in Some Men

Wed, 30 Mar 2005 00:00:00 -0800

Ophthalmologists at the University of Minnesota say that a condition that causes permanent vision loss has been diagnosed in a small group of men who have taken the erectile dysfunction drug Viagra. The condition, nonarteritic ischemic optic neuropathy (NAION), described as "stroke of the eye," occurs when blood flow is cut off to the optic nerve, which injures the nerve and results in permanent vision loss. These cases were published in the March 2005 issue of the Journal of Neuro-ophthalmology.

Seven patients, aged between 50 and 69 years, had typical features of NAION within 36 hours after ingestion of Viagra for erectile dysfunction. Seven similar cases have been previously reported.

"For years, we've known that some men who take Viagra will experience temporary color changes in their vision and see things as blue or green," said Howard Pomeranz, M.D., associate professor of ophthalmology at the University of Minnesota Medical School. "NAION is a much more serious condition because it can lead to permanent vision loss."

All of the patients had at least one arteriosclerotic risk factor, including hypertension, diabetes, hypercholesterolemia, or hyperlipidemia. All of the patients also had a low cup to disk ratio, which is a way doctors measure the small circular indentation where the optic nerve connects to the eyeball. The low cup to disk ratio means that the blood vessels and nerves are tightly bundled together into the small space in the back of the eye.

"Viagra regulates a chemical in the body to constrict the arteries. This constriction may cut off the blood flow to the optic nerve, especially in people with a low cup to disk ratio, where the blood vessels and nerves are tightly bundled provoking NAION," says Pomeranz.

The onset of NAION within hours after ingestion of Viagra in 14 patients supports an association between the use of the drug and NAION. Based on the fact that 14 cases of NAION have now been reported soon after the use of Viagra, the researchers believe that ophthalmologists should ask all men with NAION about the use of Viagra, and recommend that patients with a history of NAION in one eye be cautioned that Viagra may increase the risk of NAION in the fellow eye.

Viagra Vision Hearing Loss Lawsuit Side Effects Lawyer

Wed, 30 Mar 2005 00:00:00 -0800

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Viagra Associated with Sudden Hearing Loss
In October 2007, the Viagra label was modified to include warnings about sudden hearing loss associated with the drug. The Food & Drug Administration (FDA) had requested the changes after it had received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.

Many men who take Viagra are older, and it is not unusual for this patient population to experience some hearing loss. But that is almost always a gradual process, and sudden loss of hearing is rare. According to the FDA, the sudden hearing loss associated with Viagra was often accompanied by tinnitus – ringing in the ears – and dizziness. All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.

During Viagra’s pre-approval testing, some cases of hearing loss were reported. For that reason, there was a one-word mention of “deafness” as a potential side effect on the old Viagra label. In contrast, the new warning on sudden hearing loss is included in both the “Precautions” and “Adverse Reactions” sections of the label. In the “Precautions” area, the label now advises physicians to warn patients that sudden hearing loss is a possible side effect of Viagra. It also says that patients should stop taking Viagra and seek immediate medical attention if they experience a sudden loss or decrease in hearing, or dizziness. In the “Adverse Reactions” section, the label now warns of “sudden decrease or loss of hearing”.

Viagra Vision Loss - Nonarteritic Ischemic Optic Neuropathy (NAION)
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 (Generic: Sildenafil) for erection difficulties. Combined with past reports, this study brings the total number of sildenafil-related NAION cases to 14. Viagra was approved by the FDA in 1998.

"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.

Pfizer Inc., the world's largest drugmaker, said U.S. regulators may require a label warning that the Viagra impotence drug has been linked to reports of blindness and vision loss in at least one in a million users. The FDA has 38 reports of the blindness among users of Viagra. Pfizer has been 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.

If you or a loved one took Viagra and suffered NAION or other side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.