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:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a method ... —Johnson is one of the first doctors to perform the treatment. Orthobiologics are ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... Pa. , June 23, 2016 The ... in an outpatient dialysis facility.  Treatments are usually 3 ... 6 hours per visit, including travel time, equipment preparation ... a patient, but especially grueling for patients who are ... of a skilled nursing and rehabilitation centers for some ...
Breaking Medicine Technology: