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By megdilts, May 16, 2009 9:51 pm

Working with other FDA components, the division’s Internet and Health Fraud Team led an Internet survey in which more than one-third of purchased “dietary supplements” claiming to spur sexual enhancement or treat ED contained undisclosed prescription drug ingredients or similar substances.

Six of the 17 products contained sildenafil (the active ingredient in Viagra) or a substance similar to either sildenafil or vardenafil. Vardenafil is the active ingredient in Levitra, another FDA-approved prescription drug that treats ED.

Mark Hirsch, a medical team Leader in CDER’s Division of Reproductive and Urologic Products, says this undisclosed presence of prescription drug ingredients—and similar compounds known as analogs of the drugs—can lead to serious side effects in users.

Source: FDA Consumer Health Information

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By megdilts, May 13, 2009 3:22 pm

Men looking online for “dietary supplements” to treat erectile dysfunction (ED) or enhance their sexual performance should beware: these products may contain prescription drugs or other undisclosed ingredients that can be harmful.

“The number of these problematic products available on the Internet appears to be increasing,” says Michael Levy, director of the Food and Drug Administration’s (FDA) Division of New Drugs and Labeling Compliance. The division is part of the Office of Compliance (OOC) in the agency’s Center for Drug Evaluation and Research (CDER).

Many consumers perceive these products as completely safe because they are often sold with labeling, suggesting that they are all-natural alternatives to prescription drug products that have been approved by FDA for treating ED.

But these products may be laced with potentially hazardous ingredients that aren’t noted on the label.

Since 2004, FDA has become aware of several such “dietary supplements”

Source: FDA Consumer Health Information

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By megdilts, April 23, 2009 10:29 am

Drugs for treating ED can be taken orally, injected directly into the penis, or inserted into the urethra at the tip of the penis. In March 1998, the Food and Drug Administration (FDA) approved Viagra, the first pill to treat ED. Since that time, vardenafil hydrochloride (Levitra) and tadalafil (Cialis) have also been approved. Additional oral medicines are being tested for safety and effectiveness.

Viagra, Levitra, and Cialis all belong to a class of drugs called phosphodiesterase (PDE) inhibitors. Taken an hour before sexual activity, these drugs work by enhancing the effects of nitric oxide, a chemical that relaxes smooth muscles in the penis during sexual stimulation and allows increased blood flow.

While oral medicines improve the response to sexual stimulation, they do not trigger an automatic erection as injections do. The recommended dose for Viagra is 50 mg, and the physician may adjust this dose to 100 mg or 25 mg, depending on the patient. The recommended dose for either Levitra or Cialis is 10 mg, and the physician may adjust this dose to 20 mg if 10 mg is insufficient. A lower dose of 5 mg is available for patients who take other medicines or have conditions that may decrease the body’s ability to use the drug. Levitra is also available in a 2.5 mg dose.

None of these PDE inhibitors should be used more than once a day. Men who take nitrate-based drugs such as nitroglycerin for heart problems should not use either drug because the combination can cause a sudden drop in blood pressure. Also, tell your doctor if you take any drugs called alpha-blockers, which are used to treat prostate enlargement or high blood pressure. Your doctor may need to adjust your ED prescription. Taking a PDE inhibitor and an alpha-blocker at the same time (within 4 hours) can cause a sudden drop in blood pressure.

Oral testosterone can reduce ED in some men with low levels of natural testosterone, but it is often ineffective and may cause liver damage. Patients also have claimed that other oral drugs—including yohimbine hydrochloride, dopamine and serotonin agonists, and trazodone—are effective, but the results of scientific studies to substantiate these claims have been inconsistent. Improvements observed following use of these drugs may be examples of the placebo effect, that is, a change that results simply from the patient’s believing that an improvement will occur.

Many men achieve stronger erections by injecting drugs into the penis, causing it to become engorged with blood. Drugs such as papaverine hydrochloride, phentolamine, and alprostadil (marketed as Caverject) widen blood vessels. These drugs may create unwanted side effects, however, including persistent erection (known as priapism) and scarring. Nitroglycerin, a muscle relaxant, can sometimes enhance erection when rubbed on the penis.

A system for inserting a pellet of alprostadil into the urethra is marketed as Muse. The system uses a prefilled applicator to deliver the pellet about an inch deep into the urethra. An erection will begin within 8 to 10 minutes and may last 30 to 60 minutes. The most common side effects are aching in the penis, testicles, and area between the penis and rectum; warmth or burning sensation in the urethra; redness from increased blood flow to the penis; and minor urethral bleeding or spotting.

Research on drugs for treating ED is expanding rapidly. Patients should ask their doctor about the latest advances.

Source: National Kidney and Urologic Diseases Information Clearinghouse