Study Finds Higher STD Rates Among Users Of Erectile Dysfunction Drugs

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Sexual Health / STDs
Article Date: 06 Jul 2010 – 2:00 PDT

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Physicians who prescribe erectile dysfunction drugs for their male patients should be sure to discuss the importance of safer sex practices, even with older patients: that is an important implication of a report in the July 6 issue of Annals of Internal Medicine. The analysis of insurance records of more than 1.4 million U.S. men over 40 found that those who used ED drugs were more likely to have sexually transmitted diseases than were non-users.

“Anyone who does not practice safer sex, no matter their age, can contract an STD,” says Anupam B. Jena, MD, PhD, of the Massachusetts General Hospital (MGH) Department of Medicine, the study’s lead author. “Even though STDs are quite rare among older men – on the order of 1 per 1,000 individuals – we found that STD rates in men who used ED drugs were two to three times higher, both before and after they filled their first prescription.”

Jena and his co-authors note that ED drugs have become popular since sildenafil (Viagra) was first introduced in 1998. As early as 2002 it was estimated that up to 20 percent of U.S. men over 40 had tried an ED drug. Studies have shown both that rates of STDs, including HIV/AIDS, are rising in older individuals as well as the general public and that people over 50 are much less likely than those in their 20s to use condoms during sex or be tested for HIV infection. A survey of primary care physicians found that they rarely if ever discussed reducing sexual risk factors with middle aged or older patients.

Small studies of men who have sex with men had associated the use of ED drugs with higher-risk behaviors and increased rates of STDs. But no previous study had examined the relationship between ED drugs and STD risk in a large, representative sample of privately insured older men. For the current study, the researchers examined health insurance claims records covering 1997 though 2006 from 44 large U.S. employers. For male beneficiaries over 40 who used ED drugs, the researchers collected data covering one year before and one year after the first prescription was filled. Each ED drug user was matched with five non-users randomly selected from the database, for whom claims data covering the same two-year periods was collected.

The final study group included about 40,000 men who used ED drugs and nearly 1.37 million who did not. In both the year before and the year after the first ED drug prescription, users had significantly higher rates of STDs than non-users did in matching time periods. HIV/AIDS was the most frequently reported STD in both groups, followed by chlamydia. Since the prevalence of STDs did not markedly change after ED drug therapy began, the authors note that the difference between groups probably reflects higher-risk sexual practices among users of the drugs. The data gathered could not indicate whether ED drug use itself increased STD risk, but the authors are investigating that question in a further study.

“Health care providers need to recognize that their older adult patients who are on ED drugs are already at a higher risk of having or acquiring an STD,” says Dana Goldman, PhD, director of the Schaeffer Center for Health Policy and Economics at the University of Southern California (USC), the study’s senior author. “Both the physicians who prescribe these drugs and the pharmacists who fill those prescriptions should counsel all patients on the importance of safer sexual practices.”

Co-authors of the Annals of Internal Medicine report are Amee Kamdar, PhD, University of Chicago; Darius Lakdawalla, PhD, Schaeffer Center at USC; and Yang Lu, PhD, RAND Corporation. The study was supported by grants from the RAND Roybal Center for Health Policy Simulation, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Bing Center for Health Economics.

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University of Southern California



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Furiex Pharmaceuticals Announces Issuance Of U.S. Patent For Dapoxetine Method Of Treatment

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Jul 2010 – 1:00 PDT

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Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) announced that the United States Patent and Trademark Office issued a patent on May 18, 2010, for the method for treatment of premature ejaculation using dapoxetine. Furiex developed dapoxetine in collaboration with Alza Corporation and its affiliates. U.S. Patent No. 7,718,705 includes claims directed to dosing dapoxetine on an as-needed basis, capturing the advantage dapoxetine has over other compounds in the same class, which require a pre-loading period for efficacy. The patent will expire in 2022. Furiex has received grants of similar patent claims in over 45 countries around the world including major and emerging markets.

Alza’s affiliate, Janssen-Cilag, currently markets dapoxetine under the trademark, PRILIGYTM, in a number of markets outside the United States. PRILIGYTM has been launched in seven countries in the EU including Sweden, Austria, Finland, Germany, Spain, Italy and Portugal, as well as Mexico, South Korea and New Zealand.

“The method claims of this patent are valuable because, unlike other SSRIs, dapoxetine’s effects on premature ejaculation are evident with one dose, allowing dapoxetine to be dosed on an ‘as needed’ basis,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “Issuance of the 7,718,705 patent extends patent protection for the treatment of premature ejaculation using dapoxetine for 12 years.”

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Furiex Pharmaceuticals



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PRILIGYTM – when should I take it, what dosage?

posted by paul pkoski on 13 Jul 2010 at 5:51 am

how long before it should be taken? and it what doses ? is it available in south america?

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Increased Risk Of Cardiovascular Problems In Depressed Men With Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Depression;  Heart Disease;  Sexual Health / STDs
Article Date: 14 Jul 2010 – 3:00 PDT

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A new study in the Journal of Sexual Medicine found that the presence of depressive symptoms in men with erectile dysfunction constitutes a risk factor for a major cardiovascular event.

Erectile dysfunction and depressive mood are often associated, and both are associated with an increased risk of cardiovascular disease and death. To investigate clinical correlates further, researchers led by Elisa Bandini of the University of Florence studied approximately 2,000 male patients in a clinic for sexual dysfunction using a structured interview while also scoring for depressive symptoms.

Results show that in these subjects with erectile dysfunction, depression increases cardiovascular problems independently from other known risk factors. Furthermore, even the use of antidepressant medications did not alter the relationship between severe depressive symptoms and adverse cardiovascular events.

“Recognizing depressive symptoms in subjects with erectile dysfunction is mandatory not only for improving their sexual life, but also for preventing cardiovascular diseases,” Bandini notes.

“What is important about this study is the broader concept of the sexual medicine problem no longer being just about a man’s performance in the bedroom, but about his psychological mood and his cardiovascular health,” states Irwin Goldstein, Editor-in-Chief of the Journal of Sexual Medicine and director of sexual medicine at Alvarado Hospital in San Diego. “This is a valid reason for a woman to encourage her partner to seek help for his erectile dysfunction.”

Source:
Amy Molnar

Wiley-Blackwell



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Dangers Of Untreated Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 21 Jul 2010 – 2:00 PDT

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Research carried out by a visiting professor at the University of Hertfordshire has found that up to six million European men fail to seek help for Erectile Dysfunction (ED) which could result in underlying cardiovascular disease going undetected.

According to Professor Mike Kirby, a Visiting Professor at the University’s Health and Human Sciences Research Institute, who has just published a paper in The Journal for Sexual Medicine, ED is a highly prevalent condition affecting more than half of men of over forty, of which under thirty per cent seek help, leaving the majority untreated.

In his research paper entitled: Characteristics, Behaviours, and Attitudes of Men Bypassing the Healthcare System When Obtaining Phosphodiesterase Type 5 Inhibitors, Professor Kirby describes how he and his co-researchers conducted a large observational study among 11,889 subjects across Europe to assess how sexually active men in the general population obtained a phosphodiesterase type 5 inhibitors (PDE5is), which is the first-line treatment option for ED.

They found that three out of ten men who use a PDE5i obtained it without interaction with a healthcare provider and accessed it via unregulated Internet sites.

“Our research indicates that in Europe approximately six million men may be currently bypassing the healthcare system to obtain a PDE5i,” said Professor Kirby. “They not only expose themselves to the risks of using unapproved and uncontrolled products, but also miss important information on product use and contraindications. Furthermore, they miss the opportunity to receive appropriate health information regarding the importance of medical follow-up for unrecognised cardiovascular disease often seen in combination with ED.”

Source: Hertfordshire University



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Federal Agents Seize FastSize Extenders And FastSize EQM Erectile Quality Monitors

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Erectile Dysfunction / Premature Ejaculation;  Men’s health
Article Date: 28 Jul 2010 – 3:00 PDT

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At the request of the U.S. Food and Drug Administration, U.S. Marshals seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well as component parts used in the manufacture of the FastSize Extender. The FastSize Extender and the FastSize EQM Erectile Quality Monitor are manufactured and distributed by FastSize, LLC of Aliso Viejo, Calif.

The FastSize Extender and the FastSize EQM Erectile Quality Monitor are misbranded and adulterated because they, among other things, are unapproved and were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements. The seizure warrant was issued by the U.S. District Court for the Central District of California.

The FastSize EQM Erectile Quality Monitor device was promoted to measure penile axial rigidity (intercavernosal pressure) and to aid in the diagnosis of health related issues such as diabetes, high blood pressure, and heart disease. The FastSize Extender device was promoted to gain length, girth, and overall penile health improvement and to correct penile deformity caused by Peyronie’s disease. Because the devices are intended to diagnosis, cure, mitigate, treat or prevent diseases, they are subject to the regulatory authority of the FDA. The devices do not have approved applications for premarket approval for these uses.

During a recent inspection of the FastSize LLC manufacturing facility, inspectors noted significant deviations from cGMP regulations. Additionally, the devices are not properly listed with the FDA as required by law, and the firm failed or refused to furnish materials or information regarding the devices to federal inspectors as required under the Medical Device Reporting regulation.

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U.S. Food and Drug Administration



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Poppycock. Re: Federal Agents Seize FastSize Extenders And FastSize EQM Erectile Quality Monitors

posted by Dirk Furguson on 2 Aug 2010 at 3:23 am

More jack-booted thuggery by the Federal Government.

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The Future Is Today: Emerging Drugs For The Treatment Of Erectile Dysfunction

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Urology / Nephrology
Article Date: 03 Aug 2010 – 0:00 PDT

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UroToday.com – Erectile Dysfunction (ED) is the most common male sexual dysfunction presented for treatment, and the most thoroughly studied sexual dysfunction in men. In the late 20th century, important discoveries were made regarding both the physiologic processes of penile erection and the pathophysiology of ED. These discoveries led to the commercial introduction of the phosphodiesterase type 5 inhibitors (PDE5I), a class of medications which now accounts for the largest segment of the ED market.

While these drugs are highly efficacious for many men, a relatively large subset of ED patients who do not respond to PDE5I has been identified. Recognition of this subset of the ED population and the ageing of the population has driven researchers to investigate novel treatment targets for ED.

Increased research efforts have resulted in the development of several orally available compounds that combine high efficacy with low rates of adverse events. In this review, we address various compounds that regulate penile erection both centrally (Clavulanic acid, Dopamine and Melanocortin receptor agonists) and peripherally (novel PDE5I, soluble and particulate Guanylil Cyclase activators, Rho-kinase inhibitors and Maxi-K channel openers).

The worldwide market value of ED was $3.2 billion in 2006, with the US market being responsible for two-thirds of global sales. Given the ageing of the general population and direct-to-consumer advertising projecting the desire of men of all ages to maintain an active sexual lifestyle, a market growth rate of 4.9% is expected for the period 2006-2012. Due to increasing demand and prospective market growth, pharmaceutical companies are competing to develop more potent and better tolerated drugs.

In this article we reviewed the current ED market and important or promising targets for pharmacological therapy for ED. A wide variety of molecular targets have been identified and special attention has been given to compounds that bypass the need for endogenous NO production, one of the principle limitations of currently available oral ED medications.

By influencing targets in different pathways leading to the development of penile erection, the various compounds that are currently in development will undoubtedly cause a major change in treatment strategies of ED.

Currently available ED guidelines recommend treatment algorithms that are virtually identical for every patient, regardless of the underlying pathology causing the ED. We expect future strategies to allow treatment protocols tailored to the specific needs of each individual patient, taking into consideration the efficacy of erectile performance enhancement and the potential for adverse events.

This tailored approach may include combination of various emerging drugs to enhance efficacy in difficult-to-treat patients. Individual tailoring of treatment to the specific needs of the patient does require an extensive knowledge of the etiology of ED.

Careful characterization and study of these novel compounds by the physician and pharmacologist treating the increasing population of patients suffering from ED will be essential. We hope this review helps not only the sexual medicine specialist or urologist, but also the general practitioner and pharmacologist in the understanding of emerging drugs for ED.

Written by Maarten Albersen MD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations, etc., of their research by referencing the published abstract.

UroToday – the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
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Peyronie’s Disease Following Radical Prostatectomy: Incidence And Predictors

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Erectile Dysfunction / Premature Ejaculation
Article Date: 03 Aug 2010 – 0:00 PDT

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UroToday.com – Peyronie’s disease (PD) occurs more frequently following radical prostatectomy (RP) than it does among men in the general population, according to a report by Dr. Raanan Tal and colleagues in the Journal of Sexual Medicine.

In the general population, the incidence of PD is reported to be 3.2-8.9%. To determine the incidence among men treated with RP for prostate cancer (CaP), the investigators studied men attending a sexual medicine clinic at Memorial Sloan-Kettering Cancer Center between 2002 and 2008.

In addition to having undergone RP, they had to have, in the database, notation of a penile exam for plaques prior to surgery and have been seen in the sexual medicine clinic within 3 years of RP. The degree of nerve-sparing at RP was noted in the records and analyzed. Patients could not have had other salvage therapies for their CaP.

Patients had erectile function measured by a penile rigidity scale of 0 to 10 with 0 denoting no engorgement, 6 the minimal engorgement for penetration and 10 a fully rigid erection. The diagnosis of PD was based upon finding a plaque on physical examination. Intracavernosal injections were used and a goniometer measured the degree of curvature.

A total of 1,011 patients fulfilled the inclusion criteria and median time from RP to first sexual medicine evaluation was 5.8 months. The overall incidence of PD was 15.9%, with 77 men developing PD within one year of RP, 139 within 2 years and 161 men within three years.

Mean time to develop PD after RP was 13.9 months and mean degree of curvature was 31 degrees.

Predictors of developing PD after RP were evaluated. In multivariate analysis, younger age and white race were independent predictors of PD occurrence after RP. Cardiovascular disease was not more common in men who developed PD vs. those who did not develop PD.

Nerve sparing was not an independent predictor in multivariate analysis. Whether RP is associated with a fibrotic reaction in the penis after surgery is not known as a causative etiology.

As the men in this study were presenting to the sexual medicine clinic for initial evaluation after RP, it is not reported to what degree the incidence of PD impaired sexual function.

Tal R, Heck M, Teloken P, Siegrist T, Nelson CJ, Mulhall JP
J Sex Med. 2010 Mar;7(3):1254-61.
doi: 10.1111/j.1743-6109.2009.01655.x

Written by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

UroToday – the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
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James Street

posted by James Street on 4 Aug 2010 at 9:27 pm

Every time you discuss a common disease such as colon cancer or prostate cancer, you define what it is.

This practice seems like a waste of time to me, and condescending on top of it. But when discussing PD or Peyronie’s disease, you don’t bother to define it.

Not one man in a thousand would know what it is (unless he has it!)

Why not define it?

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Laser May Reduce Prostate Surgery’s Long-Term Erectile Dysfunction

Main Category: Prostate / Prostate Cancer
Also Included In: Erectile Dysfunction / Premature Ejaculation;  Urology / Nephrology
Article Date: 06 Aug 2010 – 3:00 PDT

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One of the challenges of prostate cancer surgery is removing the cancer-affected gland without side effects. The procedure is estimated to cause long-term sexual dysfunction in half of men.

Now, new published research by urologic surgeons at NewYork-Presbyterian Hospital/Columbia University Medical Center presents evidence that a new laser technology used with robotic prostate cancer surgery may reduce the risk of damaging the crucial nerves necessary for erections and urinary continence.

Published in the July online issue of the Journal of Endourology, the pilot study is the first to evaluate the CO2 laser for prostate cancer. The research was also presented recently at the American Urological Association annual meeting in San Francisco.

“The precision of movement available through robotic surgery is already helping reduce the risk of sexual side effects, and the early evidence is that CO2 lasers will help us be even more accurate — especially when preserving the sensitive nerve areas necessary for sexual function and urinary continence,” says Dr. Ketan Badani, director of robotic urologic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of urology at Columbia University College of Physicians and Surgeons.

CO2 lasers are widely used to treat cancer in the head and neck. A new, flexible, fiber-based delivery system is now making the treatment approach possible with robotic prostate cancer surgery.

In the procedure, Dr. Badani uses the robotic instrumentation to remove the patient’s prostate. This process is aided by the laser, which is used to dissect the plane between the nerves and the prostate, freeing the nerves and preserving them.

“Traditionally, we cut, clip or cauterize the tissue around the prostate nerves. However, these techniques can cause irreversible damage due to traction or heat injury,” explains Dr. Badani. “The CO2 laser may reduce this risk because it is low-heat and doesn’t require much manipulation of the nerves.”

The new study describes the use of the laser in 10 cases. It reports that the technology is easy to manipulate and very accurate. Patients experienced a return of urinary continence better than the norm, something the researchers found “extremely encouraging.” Future research will determine if the technology can improve outcomes with regard to the ability of men to sustain an erection, and its long-term ability to prevent cancer recurrence.

The laser technology, known as BeamPath, was provided by OmniGuide of Cambridge, Mass. OmniGuide BeamPath CO2 laser fibers are cleared for use by the FDA across a variety of open, endoscopic and laparoscopic soft-tissue cutting applications, including urology.

The paper’s first author is Dr. Philippa J. Cheetham, postdoctoral fellow at Columbia University Medical Center. Co-authors include Dr. Jaime M. Landman, associate professor of urology at Columbia University College of Physicians and Surgeons and a urologist at NewYork-Presbyterian/Columbia; Matthew D. Truesdale, a medical student at Columbia University College of Physicians and Surgeons; and Daniel J. Lee, postdoctoral fellow at Columbia University Medical Center.

According to the American Cancer Society, prostate cancer is the second most common type of cancer found in American men, and the second leading cause of cancer death in men. In 2009, it is estimated that there were 192,280 new cases of prostate cancer and 27,360 deaths from prostate cancer in the United States alone.

Source: NewYork-Presbyterian Hospital. Columbia University Medical Center



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EZVille, Ltd. Issues A Voluntary Nationwide Recall Of Revivexxx® Extra Strength Found To Contain An Undeclared Drug Ingredient

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Complementary Medicine / Alternative Medicine
Article Date: 11 Aug 2010 – 7:00 PDT

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EZVille, Ltd. of Ronkonkoma, NY, has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Revivexxx® Extra Strength distributed by the company was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx® Extra Strength an unapproved drug.

FDA advises that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Revivexxx® Extra Strength is marketed as a dietary supplement sexual enhancer for men. Revivexxx® Extra Strength is packaged in a single dose blister pack containing one oral tablet and bears UPC 8 35470 00207 9. All lots of this product with expiration dates including and prior to August 2013 currently available on the market are being recalled. The product was sold to distributors and retail stores nationwide and via internet sales.

No illnesses or injuries have been reported to the company to date in connection with this product.

EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers.

Consumers should not consume Revivexxx® Extra Strength and should return it immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking this product. Consumers with questions should contact Eric Budzinski at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, EDT.

Consumers and health care professionals should report adverse events that may be related to the use of this product to the FDA’s MedWatch Adverse Event Reporting program online at http://www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088 or by returning the postage-paid FDA form 3500 which may be downloaded from http://www.fda.gov/MedWatch/getforms.htm by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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FDA



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Novacare LLC Conducts Voluntary Nationwide Recall Of Products Found To Contain Undeclared Drug Ingredient

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Public Health
Article Date: 11 Aug 2010 – 7:00 PDT

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Novacare LLC has announced that it is conducting a voluntary nationwide recall of products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).

Novacare LLC has been informed by representatives of the Food Drug Administration (FDA) that the products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction. “Sulfoaildenafil” is not declared on the product labels. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

The recalled products listed above were distributed in bottles and/or “blister cards” to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17, 2010 are being recalled.

This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with these products.

Customers who have any of the above-named products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.

Consumers and healthcare professionals should report any adverse events that may be related to the use of the above-named products to the FDA’s Med Watch Adverse Event Reporting Program online at http://www.fda.gov/medwatch/report.htm, by phone 1-800-FDA-1088, or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm by mail to FDA Med Watch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

Novacare LLC is conducting this recall with the knowledge of the FDA. Consumers should return any unused product to the place of purchase or contact Novacare LLC directly at 801-290-1738, Monday – Friday, 10 am to 4 pm MDT.

Source:
FDA



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All opinions are moderated before being added.

Please note that we publish your name, but we do not publish your email address. It is only used to let
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If you write about specific medications or operations, please do not name health care professionals by name.

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