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FDA warns on pleasure pills PDF Print E-mail
Written by Arthur Okwemba   
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Men who have been using certain sex supplement pills to manage their impotence and enhance their sexual performance have now been put on the high alert: stop or face heart attacks or stroke.

United States premier body, Food and Drug Administration has warned anybody who has in the past used either of the seven sex enhancing pills: Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON to stop immediately and consult a doctor.

 

The FDA statement, released a few days ago, says the products are illegal drugs that contain potentially harmful undeclared ingredients.

A check by horizon established the drugs were not presently selling in the market, but two of the pharmacies, one of them on Kenyatta Avenue, indicated they have received requests from customers who were interested in the Libidus pill, after reading about its wonders on the internet.

The clients are yet to go back and make an order. Libidus was recently introduced in South Africa, a move seen by medical analysts as a strategy to avail the pills in selected African countries.

Other medical experts say once in South Africa, it will be a matter of months before it gets into the Kenyan market.

Several leading pharmacies say they can import the pills from the source or any country if someone orders for them. Alternatively, an individual can also order through the internet and get the pills delivered in his country through courier services.

Those trading Libidus, for instance, indicate on their website that is a herbal sexual enhancer, which they can ship to the customer as long as the order is over US$ 130.

With its pharmaceutical vastness and capabilities in Africa, Kenya is likely to be the next destination for some of these pills.

Pharmacy experts further warn that although the drugs are not trading in the local market using their brand names, unscrupulous traders might just be circulating them under different names.

At the moment, the drugs are promoted and sold through the internet as dietary pills for Erectile Dysfunction (ED), a condition whereby a man is repeatedly unable to get or keep an erection firm enough for sexual intercourse.

Majority of the users have been going for the pills because they are traded as side-effects-free natural alternatives to products such as Viagra, Cialis and Levitra.

Although the drugs trade as supplements that can be accessed by everybody, one of them, Zimaxx, was found by FDA to contain sildenafil, the same active ingredient found in Viagra, a drug given only on prescription.

When combined with drugs containing nitrates, sildenafil can cause blood pressure to drop suddenly to unsafe levels, leading to heart attacks, stroke, or fainting. Libidus is said to contain acetildenafil, an analogue of sildenafil.

Drugs containing nitrates are used mostly in the treatment of heart diseases, diabetes, high blood pressure, high cholesterol and chest pains. This means those who experience these conditions should not take any drug that contains sildenafil.

Ironically, men with these conditions suffer from ED problems. High blood pressure, for example, can, overtime, make if difficult for someone to have an erection.

Studies done in America and Europe have shown that over 20 percent of the men with high blood pressure complain of having ED problems.

One study, which put the rate at 26 percent, concluded that this was twice the rate of ED in men with normal blood pressure. Certain medicines for high blood pressure have also been found to be responsible for erection problems.

FDA statement says without the pills indicating they have active ingredients found in Viagra or Levitra, they are putting patients using nitrates at risk.

Said Dr. Steven Galson, Director of FDA\'s Center for Drug Evaluation and Research: \"These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products.

This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.\"

Besides Zimaxx, the federal agency says other products contain chemical ingredients that are equivalent to either sildenafil or a pharmaceutical ingredient called vardenafil, an active ingredient in Levitra, also prescription drug for treating ED.

There is no mention of any of these ingredients in any of the illegal products\' labeling, adds FDA.

In a warning letter dated 11th July, 2006, and send to the those responsible for manufacture of one the pills, Libidus, the FDA says the claims made about the efficacy of the pill indicates it is a drug and not dietary supplement.

On the Libidus website, the pill is said to provide several benefits to men, including penis remaining rock hard, even after ejaculation; prolongs sexual activity; enlarges the length and thickness of the penis; and enhances libido and sexual desire. Referring to the seven pills, FDA says: “These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients.”

Consequently, the agency has advised consumers who have used any of the pills to discontinue use and consult their health care provider.

So determined is the FDA that it stopped a shipment of 4 EVERON from entry to the United States and warned the companies selling the drugs.

The genesis of this disclosure about the contents of the seven pills started when FDA did a survey in which 17 dietary supplements marketed on the internet to treat ED and to enhance sexual performance in men were analyzed.

\"Our survey found that many of the so-called \'dietary supplements\' marketed as treatments for erectile dysfunction actually contain non-dietary chemicals, including chemicals used as active ingredients in FDA-approved drugs,” Margaret O\'K. Glavin, FDA\'s Associate Commissioner for Regulatory Affairs is quoted in the agency’s statement as saying:

She adds: “The claims made for these products were in fact claims made for the undeclared non-dietary chemicals they contain, which rendered them illegal drugs. FDA is committed to protecting the public health by removing such illegal and dangerous products from the market.\"

The current revelations comes at time when demand for pills, tablets and injections required to treat ED is high in Kenya.

Although there are no statistics of how many people in the country have erectile problem, pharmacies in the City are reporting increased sales in the recent past.

ED is a condition whereby a man is repeatedly unable to get or keep an erection firm enough for sexual intercourse. Or in some cases is able to sustain such an erection for very brief moments before the penis goes flaccid.

It is sometimes loosely referred to as impotence, because it does not involve other factors such as lack of sexual desire and problems associated with ejaculation or organism.

Studies have established that erectile dysfunction is a problem that affects men across all ages, but is more pronounced among men aged 40 years and above. Worldwide, an estimated 150 million men are said to experience the problem.

The condition is commonly associated with damage to the nerves or arteries that supply blood to the penis.

At risk are people who suffer from chronic diseases such as diabetes, kidney or heart as well as alcoholics, heavy smokers, and people using blood pressure regulating drugs, antidepressants or appetite suppressants.

Diabetes is said to contribute between 35 and 50 per cent of erectile dysfunction among men.

Men who undergo surgery to treat prostrate cancer - a disease that affects the semen making prostate gland - end up with erection problems as a side effect.

Recent studies show that stress, anxiety, guilt, depression, low esteem and fear of sexual failure are responsible for between 10 and 20 per cent of the erection problems. Riding bicycles that do not have protective pads has also been found to sever the nerves that supply the penis with blood.

The good news is, ED is treatable with pills or injections. The only problem, lament Urologists - doctors who diagnose such problems- men consult them only when sexual relationship with their partners have hit a dead end.

In countries like the United States, where men aged between 40 and 70 years have erection problems of a certain degree, associations have been formed where they console and assist each other.


 

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Visit the Conference Site to find out more 

 
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