久久亚洲国产成人影院-久久亚洲国产的中文-久久亚洲国产高清-久久亚洲国产精品-亚洲图片偷拍自拍-亚洲图色视频

  Home>News Center>Life
         
 

Female sex drug fails in FDA vote
(Agencies)
Updated: 2004-12-03 08:06

A hormone patch that works to restore a woman's sex drive should not win government approval until more studies are completed to determine the drug's risks, US federal health advisers recommended Thursday.

This handout photo released by Proctor and Gamble shows the 'Intrinsa' testosterone patch. The transdermal testosterone patch would be the first therapy approved in the US to treat low sexual desire disorder in women. [AFP]
This handout photo released by Proctor and Gamble shows the 'Intrinsa' testosterone patch. The transdermal testosterone patch would be the first therapy approved in the US to treat low sexual desire disorder in women. [AFP]
Several members of the Food and Drug Administration's advisory committee said they were not satisfied with the number of women studied so far, the length of the studies and the modest benefits of the drug.

Procter & Gamble sought to market the testosterone patch Intrinsa to women who lost their libido after their ovaries were removed. The company told the committee that significant safety concerns had not come up in clinical trials and that there was no reason to delay approval of the first drug for female sexual dysfunction.

But the committee unanimously sided on the need for more safety data.

The company said in a statement it would work closely with the agency "to agree on a practical approach to provide additional safety data."

The FDA is not bound by the committee's recommendation, although the agency usually follows the guidance. An agency decision on Intrinsa is expected in a few weeks.

Clinical trials showed that women using Intrinsa had modest improvements to their sex lives. Women who applied the patch to their abdomen twice weekly had one more "satisfying sexual event" per four weeks than did women given a placebo, according to the data presented to the advisory panel.

It took 100 women using Intrinsa for 15 to experience a beneficial effect due to testosterone, said Dan Shemas, director of the FDA's division of reproductive and urologic drugs.

By a 13-4 vote, federal advisers said that benefit was not "clinically meaningful."

Agency officials also noted a lack of controlled safety data for women who had used Intrinsa for more than six months.

The panel heard testimony that three of four women who developed breast cancer during the clinical trials were using Intrinsa.

Lisa Soule, a medical officer in the FDA's division of reproductive and urological drugs, said those cases pointed to the limitations of short-term clinical trials.

Soule dismissed as inadequate Procter & Gamble's suggested post-marketing study comparing 5,500 women expected to use Intrinsa in the first year against matching women from a database of 10 million patients for rates of cancer and cardiovascular disease.

A federally funded research project, by contrast, had to enroll nearly 17,000 post-menopausal women to begin to detect the safety problems with hormonal therapy, Soule said.

The Women's Health Initiative, a program established by the National Institutes of Health, found that post-menopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer.

There is debate about how much hormonal therapy is to blame for some ailments. But there is general agreement that this treatment increases the risk of development of clots in blood vessels, said Dr. Charles Lockwood.

"There is just no doubt. And no debate. And no discussion about that," said Lockwood, an expert in maternal fetal medicine at the Yale University School of Medicine and a member of the panel. "So, I think if there is one single element of safety that deserves the most scrutiny, it is the potential role of this patch" in promoting blood clots.

About 3 million women whose ovaries were removed would have been eligible to use the Intrinsa patch, according to the company. It was expected that the product also would have been by other women who wanted to increase their sex drive with a drug hyped as a female version of Viagra.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation and a member of the panel, said he was worried about exposing several million women to heart attack and stroke risks in order to gain one more "satisfying sexual event" per month.

"It is not an acceptable trade-off and we cannot allow this to move forward until we have more data," Nissen said.

Joan Meyer, senior director of new drug development for Procter & Gamble, said the additional safety data includes 100 more women who have used the patch for 18 months. Eighty women have been using the product for three years.

Unlike Viagra, which works to enhance a man's ability to have sex, Intrinsa increases a woman's desire for it. Removal of ovaries can cause women's testosterone levels to drop by 50 percent.



Kidman lands in 'Guinness Book of Records'
Guo Jingjing returned to training session
U2's 'Bomb' explodes at No.1 on US charts
  Today's Top News     Top Life News
 

Government rules out forming new energy ministry

 

   
 

Modified rice at least a year away

 

   
 

Putin strongly opposes new Ukraine runoff

 

   
 

EU urged to lift embargo

 

   
 

Central bank allows more RMB out of border

 

   
 

First greenhouse emissions deal inked

 

   
  A noble find reveals the life in the past
   
  Japan Princess turns 3 amid talk of throne issue
   
  Chinese HIV carriers stage dramas in Beijing
   
  McDonald's fixes Website on Taiwan identity
   
  Panchen Lama surfs Net, learns English
   
  Kidman lands in 'Guinness Book of Records'
   
 
  Go to Another Section  
 
 
  Story Tools  
   
  Feature  
  HK veteran songwriter James Wong passed away at 64  
Advertisement
         
主站蜘蛛池模板: 在线观看视频一区二区三区 | 免费的成人a视频在线观看 免费的毛片 | 精品国产一区二区三区免费看 | 99热在线观看 | 国产精品美女久久久久网站 | 免费毛片网站 | ccyycom草草影院成人91 | 欧美视频精品一区二区三区 | 91亚洲精品成人一区 | 世界一级毛片 | 欧美成人精品手机在线观看 | 国产露脸3p普通话 | 国产制服 国产制服一区二区 | 99国产精品久久久久久久... | 欧美成人免费观看bbb | 亚洲国产成人久久一区久久 | 亚洲精品综合一区二区三区在线 | 国产三级香港三韩国三级 | 久久久久女人精品毛片九一 | 99免费观看视频 | 久草视频精品 | 日韩在线观看中文字幕 | 麻豆视频一区 | 国产一区二区三区四区波多野结衣 | 12345国产精品高清在线 | 国产福利不卡一区二区三区 | 国产成人精品视频免费大全 | 亚洲欧美卡通成人制服动漫 | 国产老鸭窝毛片一区二区 | 黄色激情网站 | 依依成人综合网 | 免费大片黄手机在线观看 | 成年18网站免费视频网站 | 欧美成人精品欧美一级乱黄 | 成人久久影院 | 91精品国产综合久久久久 | 精品国产一区二区三区久 | 国产成人91一区二区三区 | 成人在免费视频手机观看网站 | 黄网站色视频免费观看w | 中美日韩在线网免费毛片视频 |