Despite the fact that it has long been a major concern for men, an evidence-based definition for premature ejaculation has not existed until now. In October 2007, the International Society for Sexual Medicine (ISSM) gathered the world’s leading sexual health experts to develop an evidence-based definition of premature ejaculation. Experts will present the definition to reporters in a special press conference on May 19th at Monday, May 19, 2008 at 10:00 a.m. at the 103rd Annual Scientific Meeting of the American Urological Association (AUA).
The ISSM has defined premature ejaculation as "a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy."
"For something that has such a profound effect on men young and old, there needs to be a definitive measure to diagnose premature ejaculation," said Ira D. kaufen viagra soft Ohne Rezept Sharlip, M.D., the study’s main author. "The hope is that more people with these symptoms will understand this is an actual health condition and seek treatment. They no longer need to suffer in silence."
The ISSM panel of experts agreed that the constructs that are necessary to define PE are: time to ejaculation, inability to delay ejaculation and negative consequences from PE. The panel concluded that the definition could also apply to men with premature ejaculation who engage in sexual activities other than vaginal intercourse, although the definition does not apply to acquired premature ejaculation.
Sharlip ID, Hellstrom WJG, Broderick GA: The ISSM definition of premature ejaculation: a contemporary, evidence-based definition. J Urol, suppl., 2008; 179: 340, abstract 988.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
American Urological Association (AUA)
1000 Corporate Blvd.
Linthicum, MD 21040
United States

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Men’s Health News
Personal stigma associated with depression is higher among men and the less well educated, according to research published in the open access journal BMC Psychiatry. The findings by the Australian team highlight the importance of developing programs to tackle the stigma associated with depression.
Researchers from the Australian National University examined both personal stigma, which is the negative attitude a person has towards depression, and perceived stigma, which describes the stigma felt by a person with depression.
"We already know that stigma is a leading cause of concern for people suffering from depression but up until now not a lot has been done to examine it," explained lead researcher Kathleen Griffiths. "Our work is critical to the successful design and targeting of programs that address the public’s negative attitudes to people with depression and help to reduce the stigma felt by those who are already depressed."
Over six thousand Australian adults, including some with depression, answered the research surveys in an attempt to investigate and compare their own levels of perceived stigma as well as personal stigma. People who had come into contact with depression had lower levels of personal stigma. The researchers found that people who scored highest on a test of depression knowledge were less likely to stigmatize the condition.
At a national level, older people were more likely to hold stigmatizing views and to believe that the public viewed people with depression in a poor light. "Interestingly" said, Griffiths, "although it is often assumed that people from rural areas have more negative attitudes to mental disorders, we did not find any difference between stigma in the country and city."
Griffiths concluded; "This is the first study to investigate predictors of personal stigma among those people with high levels of depressive symptoms. Personal stigmas were higher for males, those with less education, those born overseas and people in greater psychological distress. comprare il viagra pillole While our study showed that stigma is not as high as many members of the public think, it is still a problem. For example, as many as one-in-five Australians say that they would not work with someone with depression". We recommend developing targeted programs to reduce these levels of stigma. A good place to start might be with men, older people, those with lower education levels and those born overseas."

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Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialty pharmaceutical company, and Plethora Solutions Holdings PLC ("Plethora") (AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, jointly announced that they have initiated patient enrollment for the Phase III clinical trials in the U.S. for PSD502 for the treatment of premature ejaculation. In May 2007, Sciele signed an exclusive licensing agreement for PSD502 with Plethora Solutions.
PSD502 is a proprietary formulation of two marketed drugs - lidocaine and prilocaine - dispensed by a metered dose aerosol and developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the U.S. and for which there currently is no FDA-approved prescription treatment. The product is applied locally when needed (often referred to as "on demand" therapy) and is effective within five minutes. The product has been shown to increase ejaculation latency time substantially when compared with placebo in a multi-center Phase II study. This data was published recently in BJU International (Dinsmore W et al 2007, BJU Int 99: 369-35).
Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma, said, "We are pleased with the excellent progress Plethora has made with the development of PSD502, initiating the Phase III pivotal trials within our previously announced timelines. PSD502 for premature ejaculation addresses an unmet medical need that affects a significant number of adult males in all age groups."
Steven Powell, Chief Executive Officer of Plethora, commented, "We are pleased to be advancing PSD502 into the final stage of clinical development for the treatment of premature ejaculation. If patient recruitment proceeds as planned, we would expect to see headline data towards the end of 2008 which will be a major milestone in the life of both this product and Plethora."
Study Details:
Plethora intends to run the two pivotal studies in parallel, one in the U.S. and one in acheter cialis soft bon marche Europe. Each will be a multi-center, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. Patients will be treated for a 12-week period with an optional five-month open-label phase. The primary endpoints will be Intra-vaginal Ejaculation Latency Time (IVELT), sexual satisfaction and ejaculatory control. Secondary endpoints will include Sexual Quality of Life and partner satisfaction. The study design and powering, in agreement with both U.S. and E.U. regulatory authorities, employ validated patient reported outcomes (PROs). The two studies will recruit patients in 36 centers in Europe and 38 in the U.S. and Canada, including almost all North American opinion leaders. It also has been agreed with the regulators that one-year open-label extensions to the studies are not required, which will reduce time to study closure considerably.
About Plethora Solutions
Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder, stress urinary incontinence, interstitial cystitis, gynecological pain and premature ejaculation. In January 2006, Plethora acquired Minneapolis (MN) based Timm Medical Technologies, Inc. which markets the ErecAid® and Rigiscan® products for the treatment of erectile dysfunction (ED) to urology clinics through a US-based specialty sales team. Most recently, the ErecAid has been found to be effective for men that fail Medical Management and for men recovering from prostatectomy. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE) Further information is available at
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women’s Health and Pediatrics. The Company’s Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company’s success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.

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Men’s Health News
Even though deaths from prostate cancer death have fallen in the U.S. since screening became more common, new research is suggesting that this does not justify the need for such tests.
According to a team of scientists from the University of Bristol many other factors could be involved such as different treatment programmes for American men and some discrepancy over how deaths are reported.
Since screening became widespread in the U.S. mortality rates have fallen four times more than in the UK.
It seems that many men over 80 have evidence of prostate cancer when they die, but it is often unclear whether this or other conditions killed them, which leads to different accounts on death certificates.
The researchers say this does not mean that screening by using a blood test to detect what is known as the prostate specific antigen (PSA), is not saving lives.
But they suggest until research pins down the exact role of screening in decreasing prostate cancer mortality, it remains a matter of speculation.
Whereas prostate cancer screening became common in the States in the early 1990s, and nearly 60% of men over 50 were being tested by 2001, in the UK, between 1999 and 2002, an estimated 6% of men aged 45-84 had been tested.
At the start of the 90s, mortality rates for the two countries were similar, but after this period, the rate of decline in the U.S. at 4.17% per year, was almost four times that of the Kaufen cialis soft pillen mastercard UK, at 1.17% per year.
Simon Collin a statistician who led the research says other changes were occurring in the treatment of men with prostate cancer in the U.S. during that time and included the use of a particular hormone treatment in older men and more aggressive treatment of those with an advanced form of the disease.
Prostate cancer accounts for a quarter of cancers in men but the National Health Service (NHS) has resisted offering widespread PSA screening because the test is seen as notoriously inaccurate.
Even though 10-15% of men will have high enough PSA levels to justify carrying out a prostate biopsy, only 2-3% will require any treatment.
This means in fact that the majority will have been subjected to unpleasant, invasive and potentially costly investigations for no reason with possible serious side effects such as impotence and incontinence.
Experts say there is an urgent need for a new diagnostic test which could form part of a national screening programme and which would reliably identify the aggressive prostate cancers that need treatment.
The NHS says all screening programmes are based on an assessment that more good than harm will be achieved through their implementation and until there is clear clinical evidence to show real benefit can be gained from routine prostate screening, the NHS will not be screening men who have no symptoms for prostate cancer.
The authors of the study say while the differing outcomes are worrying, the jury is still out on whether screening is worthwhile.
The research is published in Lancet Oncology.
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Maxi-K gene therapy may be a safe and effective future option for men whose erectile dysfunction (ED) is not treatable with oral therapy. Two studies presented at the 103rd Annual Scientific Meeting of the American Urological Association (AUA) may give hope to these individuals. Researchers present their findings to reporters in a special press conference on May 20, 2008 at 10 a.m.
Maxi-K therapy is a unique, locally administrated gene-transfer technology to treat erectile dysfunction (ED). The safety and the restorative effects of the treatment have been shown by data from participants in a phase I trial. In some men, the effect lasted up to six months. The gene therapy appears safe as no transfer-related adverse events were reported more than two years after the transfer in some subjects. Unlike conventional oral therapies for men with ED, Maxi-K therapy does not require prior planning, fosters sexual spontaneity and can be used by men taking heart medication.
Researchers not only provided follow-up to previous studies on Maxi-K therapy in men, but also explored whether increased erectile function enhanced other areas of sexual behavior. Male cynomulgus monkeys with ED were observed during their injection period and while in the presence of estrogen-implanted females. Researchers observed and measured the monkeys’ number of ejaculations, time to ejaculation, number of mounts, time to first mount, number of thrusts, number of sexual invitations by the female and number of erections achieved. Researchers observed dramatic changes after gene transfer, including increases in the number of partial and full erections and a two-fold increase in erection duration. An increase in intimacy was also seen. The data imply that increased erectile function per se may lead to increased sexual function.
"This study gives hope to men who experience ED but have not responded to oral therapies," said Arnold Melman, M.D., one of the study’s authors. The importance of these observations in clinical and pre-clinical trials is that it appears that gene transfer with the Maxi-K channel enhances both erectile capacity as well as other important measures of sexual behavior."
Researchers also presented updated data reaffirming that human patients being treated with hMaxi-K therapy for ED were not adversely affected. The trial, conducted with 11 men between the ages of 18 and 65 with moderate to severe ED who received previous unsuccessful treatment, concluded that direct, organ-targeted, naked DNA gene transfer with hMax-K produced no treatment-related adverse events and the treatment is not associated other diseases or conditions. These results open the door to further testing involving Maxi-K gene transfer and could lead to its effective use in treating the human population.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Christ GJ, Andersson K, Williams K, Zhao W, D’Agostino R, Kaplan J: Restoration of erectile function and sexual behavior in atherosclerotic monkeys following maxi-k gene transfer with a smooth muscle-specific promoter. Kaufen generishe levitra J Urol, suppl., 2008; 179: 425, abstract 1240.
Melman A, Davies KP, McCullough AR, Bar-Chama N, Christ GJ: Long-term safety follow up of a phase I trial for gene transfer therapy of ED with hMaxi-k. J Urol, suppl., 2008; 179: 426, abstract 1241.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
Source: Lacey Holt
American Urological Association
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Maxi-K gene therapy may be a safe and effective future option for men whose erectile dysfunction (ED) is not treatable with oral therapy. Two studies presented at the 103rd Annual Scientific Meeting of the American Urological Association (AUA) may give hope to these individuals. Researchers will present their findings to reporters in a special press conference on May 20, 2008 at 10 a.m.
Maxi-K therapy is a unique, locally administrated gene-transfer technology to treat erectile dysfunction (ED). The safety and the restorative effects of the treatment have been shown by data from participants in a phase I trial. In some men, the effect lasted up to six months. The gene therapy appears safe as no transfer-related adverse events were reported more than two years after the transfer in some subjects. Unlike conventional oral therapies for men with ED, Maxi-K therapy does not require prior planning, fosters sexual spontaneity and can be used by men taking heart medication.
Researchers not only provided follow-up to previous studies on Maxi-K therapy in men, but also explored whether increased erectile function enhanced other areas of sexual behavior. Male cynomulgus monkeys with ED were observed during their injection period and while in the presence of estrogen-implanted females. Researchers observed and measured the monkeys’ number of ejaculations, time to ejaculation, number of mounts, time to first mount, number of thrusts, number of sexual invitations by the female and number of erections achieved. Researchers observed dramatic changes after gene transfer, including increases in the number of partial and full erections and a two-fold increase in erection duration. An increase in intimacy was also seen. The data imply that increased erectile function per se may lead to increased sexual function.
"This study gives hope to men who experience ED but have not responded to oral therapies," said Arnold Melman, M.D., one of the study’s authors. The importance of these observations in clinical and pre-clinical trials is that it appears that gene transfer with the Maxi-K channel enhances both erectile capacity as well as other important measures of sexual behavior."
Researchers also presented updated data reaffirming that human patients being treated with hMaxi-K therapy for ED were not adversely affected. comprare levitra mastercard The trial, conducted with 11 men between the ages of 18 and 65 with moderate to severe ED who received previous unsuccessful treatment, concluded that direct, organ-targeted, naked DNA gene transfer with hMax-K produced no treatment-related adverse events and the treatment is not associated other diseases or conditions. These results open the door to further testing involving Maxi-K gene transfer and could lead to its effective use in treating the human population.
In addition to the author, Ira D. Sharlip, M.D., a Member of the AUA Public Media Committee, will be on hand to answer questions and provide third-party perspective on the study.
Christ GJ, Andersson K, Williams K, Zhao W, D’Agostino R, Kaplan J: Restoration of erectile function and sexual behavior in atherosclerotic monkeys following maxi-k gene transfer with a smooth muscle-specific promoter. J Urol, suppl., 2008; 179: 425, abstract 1240.
Melman A, Davies KP, McCullough AR, Bar-Chama N, Christ GJ: Long-term safety follow up of a phase I trial for gene transfer therapy of ED with hMaxi-k. J Urol, suppl., 2008; 179: 426, abstract 1241.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients, including UrologyHealth.org, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.
American Urological Association (AUA)
1000 Corporate Blvd.
Linthicum, MD 21040
United States

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Mohammed Azim Dad (30) of 116 Chippenham Lane, Slough, SL1 5BA was sentenced to 250 hours community service on three counts under the Trade Marks Act 1994 relating to counterfeit erectile dysfunction medication, namely Viagra, Cialis and Levitra. Mr Dad appeared at Reading Crown Court following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).
Mr Dad was charged on 4 November 2005 after he was caught selling the counterfeit products to undercover agents from the drug manufacturer, Eli Lilly. The undercover agents purchased some of the products over the internet. When tested, the prescription only medicines did not contain the correct amount of the active ingredients. When Mr. Dad was interviewed by the MHRA, Mr Dad admitted to buying Viagra and Cialis from China and selling them on eBay for ??4.00. generishe cialis online kaufen mastercard Whilst being actively investigated by the MHRA Mr. Dad continued to sell the counterfeit medicines over the Internet. Mr Dad’s home was raided in July 2005, where the counterfeits were seized, with the estimated value of ??45,000 - ??50,000. He pleaded guilty to the offences in July 2006.
Notes:
The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.
If an individual is convicted of offences under the Medicines Act 1968, they can be sentenced to a maximum of two years imprisonment and/or an unlimited fine. Where appropriate the MHRA will use the Proceeds of Crime Act 2002 to determine whether or not benefits were accrued through criminal activity and will recoup illicit earnings if the individual is found guilty.

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Men’s Health News
Using a special ultrasound technique to spot areas of blood flow in the prostate gland may substantially reduce the number of unnecessary biopsies, according to a new study by urologists and radiologists at the Jefferson Prostate Diagnostic Center and the Kimmel Cancer Center at Jefferson in Philadelphia.
The researchers found that biopsies targeted to areas of increased blood flow in the prostate were twice as likely to be positive for cancer compared with conventional prostate biopsy techniques.
They reported their initial results from a clinical trial this week at the annual meeting of the American Urological Association in Orlando.
According to Prostate Diagnostic Center co-director Edouard Trabulsi, M.D., assistant professor of Urology at Jefferson Medical College of Thomas Jefferson University, finding the best areas to perform biopsies in the prostate has always been difficult. Standard methods entail simply dividing the prostate into a dozen regions within the gland, almost randomly. Center co-director Ethan Halpern, M.D., who is principal investigator on the four-year, National Cancer Institute-supported trial, has been developing and refining techniques to enhance targeted biopsy of the prostate for more than a decade.
Dr. Trabulsi, Ethan Halpern, M.D., professor of Radiology and Urology at Jefferson Medical College, and their co-workers randomly divided 63 prostate biopsy patients into two groups. One group was given the drug dutasteride, which can reduce the blood flow in benign prostate tissue, while the other half received a placebo. They then compared the results from biopsies targeted by blood flow changes using contrast-enhanced ultrasound to those that were done the standard way. The study involved 979 biopsies.
"We’ve previously shown that a two-week course of the drug Avodart (dutasteride) before biopsy reduces the benign blood flow, or background noise," Dr. Trabulsi explains, "allowing us to see subtle flow changes to target for biopsy. When we did this, we found that targeted biopsies based on the contrast-enhanced ultrasound are much more likely to detect prostate cancer. That’s the exciting part about this."
Dr. Halpern explains that standard procedures fail to diagnose prostate cancer in approximately 30 percent of men with the disease, even though the biopsy protocol may sample 12 to 18 tissue cores from the prostate. "comprare il viagra senza ricetta In the future, our goal is to perform a limited number of targeted biopsies and leave the rest of the prostate alone," he says. "This will provide a safer, more cost-effective approach to diagnosing prostate cancer."
The doctors say that the current study involves a novel ultrasound algorithm called flash replenishment imaging to show fine vascular flow differences. "The novelty is using the dutasteride before biopsy, using contrast-enhanced ultrasound and using the latest ultrasound technology to look for blood flow changes associated with prostate cancer."
"We are beginning to have patients who were operated on come back in," Dr. Trabulsi notes. "If we can show that we reliably hit the areas of cancer based on the ultrasound results and didn’t miss any, it’s a home run."

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Men’s Health News
Is screening or treatment for prostate cancer the reason for decreased mortality in the USA, compared to the UK?
The striking decline in prostate cancer mortality in the USA, compared with the UK in 1994-2004, coincided with a much higher uptake of screening in the USA.
Nevertheless, conclude researchers at the University of Bristol, speculation over the role of screening and treatment for prostate cancer will continue until evidence from randomised controlled trials is published. Their study and conclusions are published online (17 April) in The Lancet Oncology.
In the USA, prostate cancer screening based on the prostate-specific antigen (PSA) test, is almost routine. In 2001, 57% of men aged 50 years or older reported having a PSA test within the previous 12 months. By contrast, for each year between 1999 and 2002, an estimated 6% of men aged 45-84 were tested in the UK.
However, there is no robust evidence that routine PSA testing decreases prostate cancer mortality. Previously published comparisons of USA/UK prostate cancer trends - using data up to the late 1990s - showed that mortality rates in the USA and UK had begun to fall, albeit more rapidly in the USA, but the changes seemed too early to be attributed to the effect of PSA testing.
Simon Collin, from the University of Bristol, UK, and colleagues analysed trends in prostate cancer mortality in both countries between 1975 and 2004, and compared them with trends in screening and treatment.
They found that mortality rates peaked in the early 1990s and then began to decline, but after 1994, the rate of decline of mortality in the USA (4.17% per year) was almost four times that in the UK (1.17% per year). The mortality decline in the USA was greatest and most sustained in patients aged 75 years or older, whereas death rates stabilised in this age group in the UK by 2000.
The authors say that the difference in mortality could be related to different treatment and screening policies in the two countries - for example the greater use of gonadotropin-releasing hormone treatment in older men, or more aggressive treatment of men with locally advanced and asymptomatic prostate cancer found through greater PSA testing in the USA. Another factor could be the misattribution of cause of death.
They conclude: "The decline in mortality from prostate cancer in the USA is striking in comparison to the UK, but we can only continue to speculate about the relative contributions of differences in detection and treatment, or the relative balance of benefits and harms, until the publication of findings from trials provides the robust evidence that is so eagerly awaited."
In addition, the findings from this paper give support to the views from the British Association of Urological Surgeons that many recommendations in recently released UK NICE Guidance are unfounded, inappropriate and risk worsening mortality rates in the UK from prostate cancer.
Please contact Cherry Lewis for further information.
Further information:
Kaufen generishe levitra The paper: Prostate-cancer mortality in the USA and UK in 1975-2004: an ecological study by Simon M Collin, Richard M Martin, Chris Metcalfe, David Gunnell, Peter Albertsen, David Neal, Freddie Hamdy, Peter Stephens, J Athene Lane, Rollo Moore and Jenny Donovan. Lancet Oncology, 2008; 9: 445-52.

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The US Food and Drug Administration (FDA) has received reports of sudden reduction or loss of hearing following the use of PDE5 inhibitors, a class of drugs
that includes the erectile dysfunction (ED) medications Viagra, Levitra, and Cialis and also Revatio, used to treat pulmonary arterial hypertension
(PAH).
The FDA has approved manufacturers’ label changes for the ED drugs that highlight this risk more prominently and advise consumers what to do if they
experience sudden problems with hearing.
The revised labelling for the ED drugs includes a new Precaution and updated Adverse Reactions Sections. A similar update is expected soon for the PAH drug,
Revatio. PAH is a potentially fatal condition where continuous high blood pressure in the arteries of the lungs weakens heart muscle and can lead to heart
failure and death.
In some cases the sudden loss of hearing is reported to be accompanied by tinnitus (ringing in the ears) and dizziness. The FDA said it is not possible to
establish if the hearing loss and accompanying symptoms are directly caused by the drugs because medical follow up information is limited. It is possible
the symptoms are caused by other drugs or underlying medical conditions, or even other risk factors for hearing loss, or a combination of these
things.
The number of reports of people experiencing sudden hearing loss after taking PDE5 inhibitors is said to be "very small", but there is also concern that some patients,
especially the elderly, may not realise their symptoms could be drug related, said Dr Janet Woodcock, FDA deputy commissioner for scientific and medical
programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research:
"Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it."
The FDA said that patients who are taking Cialis, Levitra, or Viagra and find themselves suddenly losing the ability to hear, should stop taking them
immediately and go and see their doctor. Patients taking Revatio should not stop taking it because it is treating a potentially life-threatening condition.
Instead they should continue to take the drug but seek medical attention immediately for further evaluation and advice.
The FDA said they were prompted to search its Adverse Events Reporting System for cases of hearing loss with PDE5 inhibitors after reading an
article about a man who experienced these symptoms after taking Viagra that was published in the April 2007 issue of the Journal of Laryngology &
Otology.
The agency found 29 reports of patients experiencing sudden hearing loss (mostly in one ear only) linked with PDE5 inhibitors, with and without
tinnitus, vertigo, or dizziness. In about one third of the cases the loss was temporary.
PDE5 inhibitors relax smooth muscle tissue in the blood vessels of the penis enabling their dilation and increasing blood supply to the corpus cavernosum
which leads to an erection. PDE5 is also present in the smooth muscle in the walls of arteries in the lungs, so PDE5 inhibitors are used to treat high blood
pressure caused by when these arteries become too narrow.
Click here for "Questions and Answers about Viagra, Levitra, Cialis, and
comprare il viagra senza ricetta Revatio: Possible Sudden Hearing Loss" (FDA).
Written by: Catharine Paddock
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