Viagra lawsuit looms over 'party drug' adverts

Viagra lawsuit looms over 'party drug' adverts
By Stephen Foley
Published: 23 January 2007
Pfizer's marketing campaign for Viagra has turned the impotence pill into a "party drug" whose use is fuelling the Aids epidemic, according to a campaign group that is suing the pharmaceuticals giant.

The Aids Healthcare Foundation, which runs HIV clinics in the US and overseas and campaigns against the pharmaceuticals industry, has launched a lawsuit accusing Pfizer of reckless advertising. The organisation points to several recent Viagra promotions, including a 2005 newspaper ad that featured a smiling man asking, "What are you doing on New Year's Eve?"

Michael Weinstein, AHF president, said: "I've never before heard of a drug being marketed as a party favour. Viagra was approved to treat erectile dysfunction. The way they advertised this drug in the beginning was with [the former Senator] Bob Dole, who was a prostate cancer survivor, but now Pfizer is advertising it as a drug to improve your sex life. Erectile dysfunction is a medical condition; performance anxiety is not."

Pfizer has been in trouble with regulators over this issue, and two years ago it was ordered to pull Viagra ads set in a lingerie shop, where a man in devil horns said: "Remember that guy who used to be called 'Wild Thing'? He's back."

The AHF said that Viagra sales have been inflated by a black market in the pills. It said that users of crystal meth are combining it with Viagra to bolster their sexual performance, and are failing to take precautions against sexually transmitted diseases, leading to the spread of HIV.

The company said it does not promote Viagra for recreational use. "We have always been committed to safe and appropriate use of Viagra for the treatment of erectile dysfunction," a spokesman said.

Worldwide sales of Viagra were $450m in the final three months of 2006, compared with $430m for the same period in 2005.

Viagra suit filed in city

Viagra suit filed in city

Local user alleges pill led to partial vision loss

By Sara Eaton

The Journal Gazette

A Fort Wayne man is suing the country’s largest pharmaceutical company alleging the drug Viagra left him partially blind in one eye.

Robert Troutman, who received a Viagra sample package from his family doctor, took a pill Aug. 27, 2003, and woke the next morning to find “dramatic reduction in vision in his left eye,” according to the class-action lawsuit filed in U.S. District Court this week.

In the lawsuit, Troutman alleges Pfizer Inc. acted negligently in the promotion, production and distribution of the drug intended to aid men suffering from erectile dysfunction. Troutman was hospitalized and underwent medical procedures to determine the cause of the partial blindness. Troutman, according to the lawsuit, was not taking other medications that are warned against in the labeling of Viagra.

Troutman also contends that Pfizer misrepresented the results of studies during promotional efforts, therefore minimizing the risk of vision problems when marketing the drug to the public. Pfizer, according to the lawsuit, had the duty to responsibly research and develop the drug but failed to do so and failed to effectively alert consumers to the risks.

On behalf of men similarly situated, Troutman is seeking an unspecified amount of damages for medical expenses incurred, loss of earnings, diminished earnings and future medical expenses, as well as punitive damages.

A representative of Pfizer Inc., based in New York, did not return messages seeking comment Friday.

According to the April, 18, 2005, edition of Fortune, Pfizer is the largest pharmaceutical company in the United States. The company ranks 24th in the country’s top 500 companies and employs 115,000 people.

According to a May press releaseon the Pfizer Web site, Viagra has been used in 103 clinical trials with 13,000 patients, none of whom reported having the specific eye injury Troutman is suing over. However, the press release also says Pfizer was in the midst of trying to update the prescription labels to reflect the “rare ocular occurrences.”

The release also says that Viagra is a safe drug that has helped more than 23 million men and continues to be the leading drug to help those with erectile dysfunction.

So far, Troutman is the only person being represented in this class action lawsuit, his attorney, J. Michael Loomis, said. If other men come forward and wish to become part of the lawsuit, they can be added as a party, Loomis said.

The lawsuit states other people who would be considered part of the class are individuals who live in Indiana, orally ingested Viagra at the advice of their doctor for the treatment of erectile dysfunction, and who suffered irreversible vision loss as a result.

Lawsuit alert: Pfizer and FDA in Talks on Viagra Safety Warnings

Pfizer and FDA in Talks on Viagra Safety Warnings

Pfizer, the world's largest pharmaceuticals group, is in discussions with the US Food and Drug Administration (FDA) about updating the safety warnings for its impotence drug Viagra after rare reports of loss of vision among users.

News of the potential problem with the drug, one of the world's best-known medical brands, helped push Pfizer's share price down by nearly 2 per cent yesterday. One of the compounds in Viagra is manufactured at Pfizer's Cork plant.

The FDA confirmed that it was investigating 38 reports of partial blindness caused by non-arteritic anterior ischemic optic neuropathy (NAION) in Viagra users, but said it had not determined whether the drug was to blame.

The FDA probe comes at a time of heightened sensitivity to drug safety in the wake of a series of health scares including the withdrawal of cox-2 inhibitor anti-inflammatory drugs after concerns about strokes and skin conditions.

Pfizer released a statement saying it was talking to the FDA about updating the Viagra label to reflect these incidents. But it stressed: "There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra."

Pfizer said it had identified 23 cases of NAION-linked blindness or partial blindness. It was aware of one lawsuit, and the link between the ailment and Viagra had been highlighted in the Journal of Neuro-Opthamology in March. It has since been discussing updating information to doctors and users.

It said NAION and erectile dysfunction were common in men over 50 with high blood pressure, high cholesterol and diabetes, making it impossible to determine how far Viagra could be a contributory factor to the condition.
Story from REDNOVA NEWS:

Lawsuit alert: Viagra linked to blindness?

Viagra linked to blindness?

Monday • May 30, 2005

LONDON — An investigation has been launched into the health risks of Viagra, the popular anti-impotence drug, amid concerns that it has caused blindness in up to 50 people.

United States drugs regulators announced that they are examining a number of cases in which users have suffered optic neuropathy — known as "stroke in the eye", reported the Times.

Health officials in Britain said that they too had received reports of six suspected cases of blindness in similar circumstances — when blood flow to the optic nerve is cut off. The condition can lead to irreversible loss of vision.

Since its launch in 1998, Viagra has proved a global sensation. More than 23 million men have admitted to using it, and licensed and illegal trade on the Internet, which allows men to buy the drug anonymously, accounts for tens of millions more sales.

Officials from the US Food and Drug Administration (FDA) announced that they were investigating 42 reports of blindness, 38 among users of Viagra and four among users of Cialis, one of its leading competitors. Non-arteritic anterior ischemic optic neuropathy (Naion) can occur in men who are diabetic or have heart disease — the same conditions that can cause impotence and lead to Viagra use.

An FDA spokeswoman said that the investigation was continuing but that there was no concrete evidence that the drugs were to blame. The FDA is in touch with the manufacturers of Levitra, another drug for erectile dysfunction, in case there is a problem with the entire class of medication. There have been no cases of blindness reported by Levitra users so far.

Pfizer said that it was aware of rare cases of blindness in Viagra users and that the company was in talks with regulators to change warnings on its label. The company also emphasised that no proof existed that blindness was linked to the drug.

Pfizer is facing at least one lawsuit from a user for loss of sight.

Several experts have recently raised concerns about the possibility that Viagra might be linked to Naion. They suggested that all men suffering from the eye condition should be asked if they had taken Viagra.

Pfizer said a review of 103 clinical trials involving 13,000 patients had found no reports of the condition and that reports of loss of vision were "extremely rare".

The Medicines and Healthcare Products Regulatory Agency in Britain said that five of the six British cases, who are all over the age of 50, had concurrent illnesses that may have contributed to their blindness. Pfizer advises that possible side effects of Viagra include "bluish or blurred vision, or being sensitive to light" which "may occur for a short time".

Copyright MediaCorp Press Ltd. All rights reserved.

Blindness reported in some taking Viagra

This is how it begins.
No link; and then blammo!

Story from Reuters

Blindness reported in some taking Viagra

By Lisa RichwineFri May 27, 5:03 PM ET

U.S. regulators said on Friday they have received more than 40 reports of a type of blindness in men taking impotence drugs, most involving Pfizer Inc.'s (NYSE:PFE - news) Viagra, but have not determined if the medicines were responsible.

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

More than 23 million men worldwide have taken Viagra over the past seven years, Pfizer said. Reports are extremely rare of the condition known as non-arteritic anterior ischemic optic neuropathy (NAION), the company said. NAION can cause permanent vision loss in one or both eyes.

"FDA is aware of these reports but has not determined there is a cause and effect due to use of Viagra ... We're working with the company to make sure this information is available to doctors and patients," FDA spokeswoman Susan Cruzan told Reuters.

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

"While we expect the FDA to take these cases seriously, we do not believe they warrant concern with the product at this time," AG Edwards & Sons analyst Al Rauch said in a research note.

The news pushed shares of Pfizer, a component of the Dow Jones industrial average, down more than 2 percent, weighing on the broader market.

NO EVIDENCE OF LINK

Viagra's label currently lists the most common side effects as headache, facial flushing and upset stomach, and says less common events are bluish or blurred visions and sensitivity to light that may occur for a short time.

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

Dr. Michael Berelowitz, Pfizer's vice president for worldwide medical, said in an interview he did not think the FDA would require a "black box" warning - the strongest for prescription drugs - about the NAION reports.

Pfizer contacted the FDA about the blindness cases in March, after a study in the Journal of Neuro-Ophthalmology reported seven NAION cases in Viagra users, Berelowitz said. The study said the cases occurred within 36 hours after the men took Viagra.

All of the patients had high blood pressure, diabetes or elevated cholesterol - conditions that raise the risk of NAION, the study said. All developed some degree of blurred vision or vision loss in one eye, while one patient had the problem in both eyes.

"It's quite hard to see causality" between the vision loss and Viagra use, Pfizer's Berelowitz said.

The FDA said patients should contact a doctor if they have questions about the drugs or the condition.

Eli Lilly changed the Cialis label earlier this week to note the reports of NAION, company spokeswoman Kindra Strupp said. Five million men have taken the drug, she said.

GlaxoSmithKline officials could not immediately be reached for comment. The FDA will talk with GlaxoSmithKline about the Levitra label, Cruzan said.

FDA critic Sidney Wolfe said the agency should mandate a black-box warning for all three impotence pills, even though the blindness problem appears rare.

"The trade-off between blindness and something that could remedied by some psychological counseling is a really bad trade-off," said Wolfe, director of Public Citizen's Health Research Group.

Pfizer shares fell 1.87 percent, or 54 cents, to close at $28.36 on the New York Stock Exchange. Shares of Eli Lilly fell 5 cents to close at $59.05, and GlaxoSmithKline shares gained 38 cents to close at $49.78, also on the NYSE.

(additional reporting by Kim Dixon in Chicago)