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product_liability intrinsaProctor & Gamble’s frequent requests for approval of a female sex-drive drug called Intrinsa have met with further rejections from the FDA recently. The drug is called Intrinsa and it is a patch that women will wear on their skin. Intrinsa delivers small doses of testosterone in an effort to boost the female libido.
While most women’s bodies naturally create testosterone certain women’s levels are depleted due to aging or surgery. This depletion causes menopausal symptoms that are related to the sex drive and cause a marked lack of interest, as well as other physical problems.
The FDA has repeatedly issued concerns about Intrinsa over the past couple of years. If passed, the testosterone hormone skin patch would be the first drug approved by the FDA for treating women with sexual problems. Procter & Gamble, the makers of Intrinsa, are pushing for the drug to be used, especially in women who have had hysterectomies and who have hypoactive sexual disorder (a decrease in libido).
Ovaries do produce the hormone testosterone and may be related to the female sex drive as well. During natural aging the testosterone production decreases in the ovaries, producing a marked lack of libido. For many years doctors have experimented with giving women small doses of testosterone to treat their affliction.
Intrinsa hopes to be the first drug approved for specifically targeting the female sex drive. With an Intrinsa patch, the drug is slowly absorbed into the blood stream.
There are many concerns about Procter & Gamble’s desire to have Intrinsa approved. Recent lawsuits over approved drugs such as Vioxx have spawned a new concern over FDA approval techniques. One concern many have about Intrinsa is that only the manufacturer has tested the drug. There have been no independently run Intrinsa tests of significance.
While side effects appear to be minimal, experts are in agreement that Intrinsa’s long-term effects need to be studied carefully. There are several months of data that still need to be examined from Procter & Gamble as well. The FDA and others in the medical community are also concerned about the effects of Intrinsa on different types of women. The studies of Intrinsa tended to focus only on one particular group of women.
Because doctors and patients have used low levels of hormone therapy for many years there are concerns that other people would think that Intrinsa is safe to use for other reasons. There are currently no long-term studies done on the drug’s effectiveness or safety.
In 2002, estrogen-progesterone treatment was seen as causing several life threatening side effects, prompting a serious look at how treatments were doled out. Until Intrinsa goes through a long enough and diverse enough clinical trial, it is unlikely the FDA will approve the drug.
Intrinsa is a medical patch designed to deliver small doses of testosterone through a woman’s skin to boost the level of male sex hormone in her bloodstream. The medication is intended to reenergize stalled sex drives in women, but women have proven m...