What is Erectile Dysfunction, What Provokes It, and To What Extent Is It Extended?
Erectile Dysfunction (ED) may be defined as incapacity of man to reach or retain erection, sufficient to introduce penis to vagina, and to carry out a satisfactory sexual intercourse.
Frequency of ED is age variable. If in the age group from 20 to 40 it makes averagely 13%, whereas in the age group from 40 to 60 it is found in 15 — 20% of men. While 30% of men of 70 years old and over may suffer from erection disturbances.
In any age ED is not a normal feature, because the ability to have a regular and satisfactory sex life is one of the indispensable functions of man of any age. Erectile dysfunctions may be induced by the two groups of reasons: by psychological (psychogenic) and somatic (organic). Researches of the last 20 years has shown that purely psychological reasons (stresses, depressions, peculiarities of behavior, etc.) may rarely enough cause ED. At the same time it has turned out, that 80% of all the cases of erection disturbances are conditioned by some physical (somatic, organic) states. Among them are diabetes, high arterial blood pressure, high level of cholesterol in blood and atherosclerosis, renal and hepatic insufficiency, thyroid gland diseases, hormone disturbances, after-effects of surgery on prostate gland and straight intestine, damage and diseases of spinal cord and brain (insult, Alzheimer disease, etc.), after-effect of damages of pelvis, Peironi disease. Intake of medicines may also induce erection disturbances.
Persistent erectile dysfunction may be developed due to such bad habits as alcohol drinking, smoking and using of drugs.
FDA Reports Hearing Loss Linked To Viagra And Other PDE5 Inhibitors
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.
FDA Announces Revisions To Labels For Cialis, Levitra And Viagra
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.
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.
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