Navigation Links
FDA Diminish Hopes On ‘Female Viagra

US authorities are pouring cold water on hopes for a new drug to treat women with //low sexual desire.

The Food and Drug Administration (FDA) wants more studies to be done on the Intrinsa patch made by Procter & Gamble in order to find out what long-term side effects the drug may induce, the Los Angeles Times reported.

Intrinsa has been called "female Viagra" as it promises to restore healthy sexual appetites to women struggling with low desire.

Though experts say female sexuality is more complex than male, and affected more deeply by mood, self-esteem and the relationship, new studies of Intrinsa showed that the drug boosts desire by delivering small doses of testosterone through a woman's skin, thereby boosting the level of the male sex hormone in the bloodstream.

According to some estimates, the drug could help 11 million US women who are thought to suffer from a condition known in medical circles as hypoactive sexual desire disorder, or HSDD.

But though it took only six months for the FDA to approve Viagra for enhancing male libido, there is no approval in sight for the female version.

Acknowledging the "huge demand" that would probably come with approval, panel members worried aloud that long-term use by millions of women might increase the rates of breast cancer, heart disease and stroke.

The concerns were increased by the belated recognition that hormone replacement therapy, used for years to soften the effects of menopause, was linked to a significant increase in heart disease, breast cancer and strokes.

The cautious approach is also because of mounting concern over long-term safety of new drugs prompted by the discovery last December of the potentially fatal side effects associated with the anti-arthritis drug Vioxx.

Last December, just weeks after Vioxx was pulled from the market for safety concerns, an FDA panel gave the testosterone patch - made by Procter & Gamble - the equivalent of a blinking red light.

Thus the FDA wants extensive five-year clinical trials involving thousands of women.

Even two recent studies that indicated that Intrinsa significantly helped women and led to an increase in "satisfying sexual events" is unlikely to change the mind of the FDA as it is set for a review of the drug, according to the report.

One study published last week in the Archives of Internal Medicine found that women who used the patch for 24 weeks reported, on average, a 67 percent increase in their sexual desire, compared with a 48 percent increase in desire reported by women taking a placebo, or dummy pill.

It also boosted the number of "satisfying sexual encounters" from an average of three per month to about five.

A similar finding was reported in May by researchers at Baylor Medical College.

The issue has sparked a debate in the medical world, with some experts applauding the FDA for its cautious approach and others charging it with setting a higher standard of safety for drugs designed to increase female sexuality.

Procter & Gamble remained confident that the hurdles could be overcome.

"We're in talks with the FDA, working out a practical approach to address their concerns about safety," said spokeswoman Elaine Plummer, adding that no studies to date have suggested serious negative effects.

-(DPA)

Medindia on Viagra: ViagraTM is the first approved non-surgical treatment for erectile dysfunction that does not have to be either injected or inserted directly into the penis to achieve and maintain erection. The US Food and Drug Administration (FDA) approved it for prescription sale at the end of March 1998. Viagra does not directly cause penile erection, but affects the response to sexual stimulation.

For more information: http://www.medindia.com/patients
/patientinfo/impotence.asp

'"/>




Related medicine news :

1. The Use Of Antioxidants To Diminish Effects of Alcohol During Pregnancy Questioned
2. Arithmetic Skills Found To Diminish With Progression Of Alzheimer’s Disease
3. Soldiers Returning From Iraq Suffer From Diminished Mental Functioning
4. Diminishing Differences and Empowering Eves
5. High Hopes Pinned At Hungarian Bird Flu Vaccine
6. Hearing May Be Regained: Research Provides Hopes
7. India Hopes to Become Free of Bird Flu Soon
8. By Targeting Specific Germs, Hospital Hopes to Improve Pneumonia Treatment
9. Effective Strategy Against Bird flu-Spainish Flu Vaccine Raises Hopes
10. Canadian Researchers Raise Hopes of Treatment for Memory Loss
11. Earth Day Celebrated With Hopes of a Greener Tomorrow
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... ... Ellevate Network, the leading network for professional women, brought together some of ... their inaugural Summit in New York City in June. The event was livestreamed with ... 3 million. To watch the Mobilize Women video, click here . , ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
(Date:10/12/2017)... ... 12, 2017 , ... The company has developed a suite ... regulatory authorities worldwide. From Children’s to Adults 50+, every formula has been developed ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, ...
(Date:10/12/2017)... LOS ANGELES (PRWEB) , ... October 12, 2017 ... ... of Parsa Mohebi Hair Restoration, has recently contributed a medical article to the ... doctors, on cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy Innovations ... literacy software tool, and the Cancer Patient Education Network (CPEN), an independent professional ... announce a new strategic alliance. , As CPEN’s strategic partner, HLI will ...
Breaking Medicine News(10 mins):
(Date:9/23/2017)... HORSHAM, Pa. , Sept. 22, 2017 ... received a complete response letter from the U.S. Food ... (BLA) seeking approval of sirukumab for the treatment of ... response letter indicates additional clinical data are needed to ... of moderately to severely active RA. ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., ... analytics, today announced that it has been ranked #1 by ... Black Book™ Rankings 2017 User Survey. ZirMed was recognized ... for large hospitals and medical centers over 200 beds and ... Book,s healthcare technology user survey history. ...
Breaking Medicine Technology: