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.
AdvertisementAt 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.