Navigation Links
Testosterone patch for women Rejected For safety Reasons

The experimental testosterone patch used for treating women with sexual difficulties was rejected by a panel of advisors to the US Food// and Drug Administration recently .

Procter & Gamble, global manufacturer of household products, wants to market the patch to women who have become menopausal after ovarian surgery however due to the rejection by members of the FDA panel the drug is kept on hold until more data is available to assess the drug.

At a recent meeting panel members strongly criticized the company funded clinical trials as "inadequate" to assess issues of long term safety. Panel members also raised serious concerns about the risks of cardiovascular disease and breast cancer associated with a drug that appeared to offer women, on average, little more than one extra episode of sexual activity a month, compared with placebo.

Panel members also say that don't want to expose several million American women to the risk of myocardial infarction and stroke, with such devastating consequences, in order that they can have one more sexual episode a month .

So far no data has been published by Procter & Gamble's after their 24 week randomised controlled trials of the patch . Abstracts presented at conferences have claimed repeatedly that the drug is safe and effective and has side effects similar to those of placebo. Yet data presented at last week's FDA meeting showed that women using testosterone were more likely to experience hair growth, acne, and weight gain.

Procter & Gamble's officials and the company's paid academic consultants have been questioned by the FDA about the clinical meaningfulness of the drug's small benefits, the lack of long term data, and the scientific uncertainties that surround the link between testosterone concentrations and sexual difficulties. Procter & Gamble has also agreed it will work with the FDA and try to provide additional safety data before the launch of the drug in the market.


Related medicine news :

1. Testosterone Replacement Therapy Safe If Monitored Appropriately
2. Low Testosterone Levels the Cause Of Depression In Men
3. The Use Of Testosterone Replacement Therapy Questioned
4. Depression In Men Could Be To Low Testosterone Levels
5. Testosterone Patches Found To Increase Sexual Desire In Menopausal Women
6. Testosterone Therapy can improve sexual function in postmenopausal women
7. Fatherhood Found To Tame Men by Reducing Testosterone Levels
8. Testosterone levels could serve as a marker for determining risk of SIDS
9. Males Lifespan Shortened By Elevated Levels Of Testosterone
10. Study Indicates An Increased Risk Of Breast Cancer In Women Undertaking Estrogen and Testosterone Therapy
11. Low Testosterone Linked With Early Death
Post Your Comments:

(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health Partners, ... new Wimbledon Athletics Facebook page to educate the public, parents and ... abnormalities. About 2,000 people under the age of 25 die from sudden cardiac ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for the ... of the benefits of Botox® in the treatment of moderate facial wrinkling, few have ... pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism (the ...
(Date:11/25/2015)... ... 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, will ... Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final production ... been a treasured tradition for numerous families in the Evanston community. Over the ...
(Date:11/25/2015)... D.C. (PRWEB) , ... November 25, 2015 , ... Today, ... fatalities on our nation’s roadways has dropped below 10,000 for the first time since ... 10,076 in 2013. , According to data released by the National Highway Traffic Safety ...
(Date:11/25/2015)... ... November 25, 2015 , ... "When I ... regular bras were incredibly uncomfortable," said an inventor from Bronx, N.Y. "In order ... developed the patent-pending RECOVERY BRA for added comfort and support. The bra is ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the European Cell Surface Marker ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
(Date:11/25/2015)... , Nov. 26, 2015  The total global healthcare ... 7% over 2015-2016. Latin America has ... , (excluding Japan ), is second ... continues to face increased healthcare expenditure. In 2013-2014, total ... declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. In ...
(Date:11/25/2015)... WASHINGTON , Nov. 25, 2015  The ... Obstetricians and Gynecologists (ACOG), and the March of ... bipartisan Protecting Our Infants Act of 2015 ... the number of newborns born exposed to drugs, ... Since the bill,s introduction, all three organizations have ...
Breaking Medicine Technology: