Do you really need to see...

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Friday, May 27, 2005

WASHINGTON - Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra and viagra cialis online pharmacy pharmacy, a disclosure that comes at a time when the drug industry can ill afford negative publicity about another class of blockbuster medicines.

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

"We take this seriously," said FDA's Cruzan.

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

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

Viagra manufacturer Pfizer Inc. also refers on its Web site to some vision issues: "Less common are bluish or blurred vision, or being sensitive to light. These may occur for a short time." That language had been available before the current inquiry.

Pfizer spokesman Daniel Watts confirmed Friday that the drugmaker was in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness. However, he said there is no proof that Viagra caused the blindness. He said that men who take Viagra often have high blood pressure and high cholesterol, which are also associated with the conditions that can cause blindness.

Levitra is sold in the United States by GlaxoSmithKline PLC and Bayer AG.

Viagra was approved by the government in 1998. It may aid in the treatment of enlarged hearts that can result from high blood pressure, tests on animals indicate.

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

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

Levitra, Cialis and Viagra all work in the same fashion, but Flemming said that doesn't mean they all have the same side effects. "Every drug is different. Every drug is unique," he said.

Analyst Jason Napodano of Zacks Investment Research Inc. said he doesn't think Viagra sales will stumble because of the new reports because the number of cases is so small. "It is too early to say that Viagra is causing this (the blindness) and look how small the numbers are," he said.

Viagra, approved to treat erectile dysfunction, should not be used by men with heart conditions whose doctors have warned them not to have sex. Also, patients taking drugs that contain nitrates have been warned not to take Viagra because of sudden, unsafe drops in blood pressure.

The drug's label also warns of erections lasting longer than four hours, painful erections lasting longer than six hours, headache, flushed skin and vision problems.

Pfizer Inc. said in its most recent quarterly filing with the Securities and Exchange Commission that sales of the drug rose 5 percent - to $438 million in the first quarter of the year. Pfizer also said at the time that Viagra had a 68 percent worldwide market share.

Viagra sales have been under pressure from new competitors Cialis and Levitra, with revenue sinking 11 percent last year to $1.68 billion from $1.88 billion. Pfizer shares fell in early trading on the New York Stock Exchange.

Doctors and patients have become increasingly wary of the downsides of prescription drugs after Merck & Co. yanked its pain reliever Vioxx from the market last year because of its potentially lethal side effects.

Merck potentially faces thousands of lawsuits over Vioxx and analysts have estimated its liability may reach $18 billion.

Pfizer was asked to remove its pain reliever Bextra from the market because of its side effects and sales of its other arthritis drug Celebrex are falling. Vioxx, Celebrex and Bextra all fall into a category of drugs known as Cox-2 inhibitors.

Industry critics have been demanding that drug companies conduct more post-marketing studies in order to do a better job of discovering side effects once drugs hit the market.

For more than two decades, Americans have mostly pressed for quicker approval of what they hope can be lifesaving drugs for such diseases as AIDS and cancer. But many now are wondering if medicines - a $200 billion industry annually - are coming out too fast and doing too much harm.

Viagra also is at the center of controversy over Medicaid's payment for prescriptions of the drug to convicted sex offenders in New York and other states.

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On the Web:

http://www.viagra.com/getTheMost/index.asp

http://www.fda.gov

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Associated Press writers Theresa Agovino in New York and Elizabeth Wolfe in Washington contributed to this story

Boehringer Ingelheim’s lead hepatitis C compound moves into phase III – the first within the BI HCV portfolio

02 April 2011



FDA Fast Track designations granted for both: the protease online pharmacy viagra BI 201335 plus standard-of-care and the interferon-free combination of BI 201335 with polymerase inhibitor, BI 207127



Not for U.S. media



INGELHEIM, Germany, 2 April 2011 – Boehringer Ingelheim today announced the study outline for the pivotal Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus (HCV), the most challenging genotype to treat.



In parallel, the U.S. Food and Drug Administration (FDA) has granted Fast Track designations for BI 201335 plus standard-of care (SOC), and as part of the interferon-free combination with the polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients.



"We are delighted to receive the FDA’s Fast Track designation for both, our BI 201335 plus SOC, and interferon-free combination treatment approaches. If successful, the combination therapy carries the potential for patients to live without the burden of interferon’s side effects," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.



"We are committed to bringing BI 201335 forward, with the ambition of improving cure rates for the benefit of those living with hepatitis C."



BI 201335 Phase III Trials*



BI 201335 will be evaluated in multiple randomised, double-blind, placebo-controlled trials in combination with pegylated-interferon and ribavirin (PegIFN/RBV), the current HCV SOC. The Phase III trials include two studies in treatment- naïve and one study in treatment-experienced chronic genotype-1 HCV patients. The two studies in treatment-naïve patients will be conducted in the European Union and Japan, as well as the U.S., Canada, Taiwan and Korea. The study in treatment-experienced patients will be conducted globally. BI 201335 will be dosed once-daily at either 120mg or 240mg in combination with PegIFN/RBV and treatment durations will range from 24 to 48 weeks. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure. These studies are part of a broader Phase III trial programme expected to commence in the second quarter of 2011.



PegIFN-Free Phase II Trials of BI 201335 + BI 207127



In parallel, Boehringer Ingelheim is developing BI 207127, an oral HCV polymerase inhibitor that has completed Phase I clinical trials in combination with BI 201335. Phase II trials evaluating BI 207127 plus BI 201335 in PegIFN-free regimens, both with and without ribavirin, are currently underway. The FDA has designated this investigation as a Fast Track development programme. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.



About Hepatitis C Virus (HCV)



HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 170 million, with 3–4 million new infections occurring each year. Only about 20–45% of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20% will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is 2-5% per year. End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.



About Boehringer Ingelheim in Virology



Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research programme for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV (VIRAMUNE® (nevirapine) tablets/oral suspension, the first approved HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) and Aptivus®, an HIV protease inhibitor). The company has a well established research centre in Laval, Canada, dedicated to virology research since the early 1990’s, and is committed to developing new therapies for virological diseases with a high unmet medical need.



Boehringer Ingelheim in Hepatitis C Virus (HCV)



BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.



Boehringer Ingelheim



The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.



In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro (US $17.7 billion) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.



For more information, please visit http://www.boehringer-ingelheim.com/



www.twitter.com/boehringer



*Final results of the Phase II studies SILEN-C1 and SILEN-C2 for BI 201335 were presented yesterday at the International Liver Congress TM 2011, the 46 th Annual Meeting of the European Association for the study of the liver (EASL) in Berlin.



Source

Treating Symptoms of Benign Prostatic Hyperplasia - Positive Results from Phase 2 Study of Tadalafil Part 2

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Ambrisentan be the opening non-sulphonamide social order endothelin receptor antagonist (ERA) and the first PAH tablets passed in leg of WHO Functional Class II patients contained by Europe.

ICOS Corporation, a biotechnology enterprise headquartered in Bothell, Washington, is unswerving to publicize ahead of its time therapeutics to patients. Through Lilly ICOS LLC, ICOS is marketing its pilot employ, Cialis®. ICOS is compatible to refine treatment for insightful unmet medical wants such by way of pulmonary arterial hypertension, benign prostatic hyperplasia, hypertension, cancer and inflammatory disease. Additional statistics going next to for ICOS is going spare at Lilly, a superseding innovation-driven company is developing a swiftly expanding portfolio of first-in-class and best-in-class pharmaceutical products by apply the most up-to-date research from its personal macro laboratories and from group effort with prominent solid organization. Headquartered in Indianapolis, Ind., Lilly provide answers -- through medicines and information -- for whichever of the world's most essential medical needs. Additional information about Lilly is available at Except for historical information contained herein, this pinch giving out contain forward-looking statement within the gist of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are plinth on characteristic expectations, estimate and projection about the industry, admin way of life and unquestionable presumption made by the management of ICOS and Lilly. Investors are caution that article care to forward-looking statements take in for questioning risk and uncertainties, with monetary, ruthless, governmental, industrial, trial and other factor discuss in the two companies' respective filings with the Securities and Exchange Commission, which may affect the conglomerate and prospects of the two company and Lilly ICOS. Results and the time and consequence of measures may be dissimilar materially from those expressed or implied by the forward-looking statements here press release. More expressly, within can be no self-possession that tadalafil will wrench off commercial glory or that opposing products will not pre-empt marketplace opportunity that may perhaps subsist for the product.

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Teen Texting and Sex

Study links excessive texting among teens to sex, drugs.
The AP (11/10) reports, "Teens who text 120 times a day or more -- and there seems to be a lot of them -- are more likely to have had sex or used alcohol and drugs than kids who don't send as many messages, according to provocative new research." The authors of the study "aren't suggesting that 'hyper-texting' leads to sex, drinking or drugs, but say it's startling to see an apparent link between excessive messaging and that kind of risky behavior."
In "Vital Signs," the New York Times (11/9, Rabin) reported that "the study by researchers at Case Western Reserve University, presented Tuesday at a meeting of the American Public purchase cialis Association in Denver, is based on data from questions posed last year to more than 4,000 students at 20 urban high schools in Ohio." Approximately "one-fifth sent at least 120 text messages a day, one-tenth were on social networks for three hours or more, and four percent did both." Notably, "that four percent were at twice the risk of nonusers for fighting, smoking, binge drinking, becoming cyber victims, thinking about suicide, missing school, and dozing off in class."
"The hyper-texters were 3.5 more likely to have had sex than teens who texted less," the Time (11/9, Melnick) "Healthland" blog reported. "The hyper-networkers, however, were not more likely to have had sex compared with the hyper-texters," but "they did exceed the texters' predilection for fighting, drinking and drug use," according to the study authors.
Teen girls more likely to have risky sex, study suggests. The Time (11/9, Melnick) "Healthland" blog reported, "A doctoral candidate at Arizona State University made a surprising discovery during the course of her dissertation research on the impact of early sexual cheap cialis education." Nicole Weller "found that regardless of what type of sex-ed they received, teen girls were 30% less likely than teen boys to use protection during their first sexual encounter. She also found that black teens were 40% less likely than white teens to use protection the first time they had sex." The researcher "presented her analysis of data from the National Survey of Family Growth, in which she looked at responses from 5,012 adolescents aged 11 to 19," at "the annual American Public Health Association Social Justice Meeting and Expo in Denver."