Mens Health Erection Articles

The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.
Kaufen generishe cialis In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.
The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
"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," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.
A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.
Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.
Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling. The label revisions can be viewed here.
For more information
click here.

View drug information on Cialis; Levitra; Viagra.
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Men’s Health News
Encapsulating magnetic iron oxide nanoparticles within a silica shell has yielded a new multifunctional nanoparticle that has the potential to image, target, and treat tumors with water-insoluble anticancer drugs. A report of this work appears in the journal ACS Nano.
Jeffery Zink, Ph.D., led a research team at the University of California, Los Angeles, that created the new nanoparticles, which contain an iron oxide nanoparticle core and a porous silica shell. The investigators coated the resulting nanoparticles with folic acid, a tumor targeting agent, and a fluorescent dye to enable optical imaging. Soaking the nanoparticles in a solvent containing either paclitaxel or camptothecin, both of which are poorly soluble in water and difficult to deliver to tumors as a result, resulted in significant drug loading through the pores in the silica shell. Tests showed that the drug-loaded nanoparticles were stable for at least 2 months.
Kaufen cialis soft pillen mastercard Experiments with pancreatic cancer cells demonstrated that the targeted nanoparticles were taken up rapidly by cancer cells, whereas untargeted control nanoparticles were not. The researchers were able to quantify nanoparticle uptake using both MRI and optical spectroscopy thanks to the iron oxide nanoparticle core and fluorescent dyes, respectively. The targeted nanoparticles were also more toxic to the tumor cells than were untargeted nanoparticles.
This work, which was supported in part by the NCI, is detailed in the paper "Multifunctional Inorganic Nanoparticles for Imaging, Targeting, and Drug Delivery." An abstract of this paper is available at the journal’s Web site. View abstract

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"Men with diabetes who are having trouble keeping an erection could be at increased risk of serious heart problems", BBC News reported. It said that a study has found that those with erectile dysfunction are twice as likely as other men with diabetes to develop heart disease. This finding could apparently be used to "alert both patients and healthcare providers to the future risk of coronary heart disease".
This study followed 2,306 diabetic men for four years and found that the men with erectile dysfunction were 1.58 times more likely to have a cardiac event (fatal or non-fatal heart attack or surgery for heart disease). It has some potential weaknesses, for example it might not have used the most accurate method for classifying erectile dysfunction, some of the participants may already have had heart disease before the study began, and other drugs they were taking could have had an effect.
Despite its shortcomings however, this research corroborates what other studies have suggested. It suggests that an assessment of erectile dysfunction could be useful when assessing the risk of heart disease in men with diabetes.
Where did the story come from?
Dr Ronald Ching-Wan Ma and colleagues from the Chinese University of Hong Kong carried out the research. The study was supported by an MSD University Grant and by the Hong Kong Foundation for Research and Development in Diabetes. The study was published in the Journal of the American College of Cardiology.
What kind of scientific study was this?
It is known that men with diabetes have a higher risk of erectile dysfunction and its prevalence increases with age, and duration and severity of the diabetes. Previous research has suggested a close association between erectile dysfunction and atherosclerosis, while other studies have indicated that it could be used as an indicator of coronary, peripheral or cerebrovascular disease.
The authors of this study aimed to be the first to use a prospective analysis to see if the presence of erectile dysfunction can be used as a predictor of adverse cardiovascular events such as coronary heart disease. In this prospective cohort study, the researchers included men with diabetes at the Prince of Wales Hospital Diabetes Centre, Hong Kong between 1995 and 2005. The suitability of 3,640 men who had been referred to the centre was assessed. The researchers excluded any men who had type 1 diabetes, cardiovascular disease at the start of the study (through medical history or abnormal ECG or stress test) or for whom there was incomplete information on erectile dysfunction.
This left 2,306 men with type 2 diabetes who had been assessed for the complications and risk factors associated with their condition. The participants had a series of clinical and laboratory assessments, including at least two urine collections to measure protein levels. This would give an indication of kidney function. In addition, they were asked whether they suffered from erectile dysfunction (they could answer yes or no).
The researchers followed up the participants for an average of four years, during which time they collected data on hospital admissions and mortality. In Hong Kong, all residents have a unique identification number and researchers used this to link hospital records and diagnoses (e.g. death from acute heart attack or other coronary cause, or non-fatal cardiac events) with the participants’ original data from the study. In this way, they could see if there was an association between heart problems and erectile dysfunction in men with diabetes.
When analysing this association, the researchers took into account other factors that can have an influence on erectile dysfunction or heart disease, including; smoking history, age, how long they had diabetes, use of blood pressure and other medications, blood pressure, blood cholesterol, BMI and waist circumference.
What were the results of the study?
The researchers found that at the beginning of the study, 27% of the men reported having erectile dysfunction. These men were older, had higher blood pressure, had had diabetes for longer, and had higher blood cholesterol.
During approximately four years of follow up, new cardiac events occurred in about 5% of men. Men with erectile dysfunction were 1.58 times (HR 1.58, 95% CI 1.08 to 2.30) more likely than men without erectile dysfunction to experience a cardiac event during follow up. This analysis took into account some other factors that might be responsible for the association. Erectile dysfunction was not the only factor that increased cardiac events; age, duration of diabetes, high levels of protein in urine, and use of medications for high blood pressure were also independently associated.
What interpretations did the researchers draw from these results?
The researchers conclude that there is an association between erectile dysfunction and new cardiac events in men with type 2 diabetes. They say that erectile dysfunction is a "surrogate marker" for future heart problems.
What does the NHS Knowledge Service make of this study?
The researchers raise several possible problems associated with this study. These should be kept in mind when interpreting the results:
- Generic lasix pills no prescription Studies that assess sensitive topics such as erectile dysfunction are difficult to carry out accurately. The men who took part might not have fully reported the extent of their erectile dysfunction, leading to an underestimation of the problem. For example, if a large number of men with erectile dysfunction did not report it and were free of cardiac events during follow up, their results may have swayed the conclusions to being not significant. On the other hand, if some men didn’t report their erectile dysfunction and experienced cardiac events, the study will have underestimated the strength of the association.
- The researchers say that the single question they asked to determine whether a man suffered from erectile dysfunction, may not have been as appropriate as using other questionnaires that ask more objective questions. If men with more severe dysfunction were more likely to answer yes, then the study’s findings would be biased.
- The study was carried out in Hong Kong and the men who took part might not be representative of men from other countries. In particular, it’s unclear if the findings from the study are applicable to men in western countries as lifestyle factors across cultures may contribute differently to a person’s overall risk profile.
- Though the researchers tried to exclude any men with evidence of cardiac problems, they say that "comprehensive cardiac assessments were not routinely performed in asymptomatic patients". This means that people with no obvious clinical symptoms could have been included. If this were the case, the researchers had no way of identifying those whose erectile dysfunction was actually a result of their heart problems.
- This study suggests that there are several independent factors associated with erectile dysfunction - namely age, use of medications, duration of diabetes and high protein levels in urine. Determining which of these is the most important is difficult. Future studies should particularly assess the contributions made by drugs such as lipid lowering statins that are known to cause erectile dysfunction. Most people with diabetes will be on multiple drugs with the potential to cause this condition.
It is known that men with diabetes are more likely to have erectile dysfunction and that this problem is associated with atherosclerosis (narrowing and hardening of the arteries). This study provides data to support the association that other studies have found between erectile dysfunction and cardiac problems. It is important that these results are confirmed in larger populations and across cultures.
Links to the headlines
Sex problems ‘may be heart alert’. BBC News, May 21 2008
Links to the science
Erectile Dysfunction Predicts Coronary Heart Disease in Type 2 Diabetes.
R C-W Ma, So W-Y, Yang X, et al.
J Am Coll Cardiol 2008; 51: 2045-2050
This news comes from NHS Choices
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generishe levitra pillen Ohne Rezept Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc.
(NYSE: KG) announced today that they have delayed plans for the initiation
of Phase 3 clinical trials with bremelanotide, a first in class
melanocortin agonist drug candidate, for the treatment of male erectile
dysfunction (ED). The decision follows responses from representatives of
the U.S. Food and Drug Administration (FDA), which raised serious concerns
about the acceptable benefit/risk ratio to support the progression of the
proposed program into Phase 3 studies for ED.
After reviewing the data generated in the Phase 1 and 2 studies, the
FDA questioned the overall efficacy results and the clinical benefit of
this product in both the general and diabetic ED populations, and cited
blood pressure increases as its greatest safety concern. Though not
supportive of the proposed Phase 3 studies for ED with bremelanotide, the
FDA stated that it was amenable to proposals for a different drug
development pathway, such as for a second-line therapy in non-responders to
currently approved PDE-5 inhibitors.
"The safety of patients in our clinical program has always been our
number one priority and we will work closely with the FDA, King, and our
advisors to determine the next steps for the program," stated Carl Spana,
Ph.D., President and Chief Executive Officer of Palatin.
Palatin and King plan to review the FDA comments in the overall context
of the program in order to determine next steps related to the further
development of bremelanotide for the treatment of ED.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated
with increasing age, cardiovascular disease, hypertension, diabetes,
hyperlipidemia, and smoking. In addition, certain prescription drugs and
psychogenic issues may contribute to ED. It is estimated that some degree
of ED affects one half of all men over the age of 40 and that 150 million
men worldwide suffer from ED.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on
discovering and developing targeted, receptor-specific small molecule and
peptide therapeutics. Palatin’s internal research and development
capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling
product development. Palatin’s strategy is to develop products and then
form marketing collaborations with industry leaders in order to maximize
their commercial potential. To date, Palatin has entered into
collaborations with AstraZeneca, King Pharmaceuticals, and Tyco Healthcare
Mallinckrodt. For additional information regarding Palatin, please visit
Palatin Technologies’ website at
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions,
of novel branded prescription pharmaceutical products in attractive markets
and the strategic acquisition of branded products that can benefit from
focused promotion and marketing and product life-cycle management.
Palatin Technologies, Inc

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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,
kaufen viagra Ohne Rezept 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
Revatio: Possible Sudden Hearing Loss" (FDA).
Written by: Catharine Paddock
View drug information on Cialis; Levitra; Viagra.
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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