Originally published October 5 2015
FDA is anti-science? FDA memo shows that female libido pill was approved for political reasons, despite medical and scientific objections
by Jennifer Lea Reynolds
(NaturalNews) A libido-boosting pill by the name of Addyi, which has been dubbed the "female Viagra," is set to hit the U.S. market in October 2015. Don't be so quick to think this is a good thing; although the pill, which is made by Sprout Pharmaceuticals, Inc. and chemically known as flibanserin, has been approved by the Food and Drug Administration (FDA), several health questions surrounding the drug's benefits and risks are still looming.
That's right. It has been given the thumbs-up by the FDA despite the fact that the powers that be aren't entirely sure about the effect it has on women other than the fact that it's been shown to boost sexual desire - and even then, it has only been shown to provide "meaningful" help for about ten percent more patients than those taking a placebo. Let's not forget the fact that even though the pill is designed specifically for women, various aspects of its effects on health were tested mostly on men. For example, alcohol interaction tests involved a study of 25 healthy people, 23 of whom were men.
Despite risks and persisting concerns, Addyi approved
Such information comes from an FDA regulatory action memo in which the agency outlines these and other medical concerns about Addyi. Although several members felt that approving Addyi would be a gesture done in haste because they felt more studies were needed, it was ultimately given the okay by Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products.
In the portion of the memo in which Joffe offers his rationale for approving the drug, he states the following:
...while two experts may agree on a set of facts regarding the benefits and risks of a drug, the experts may not agree on accepting the risk given the demonstrated benefits of the drug. This is the situation face the flibanserin application--there is internal agreement on the facts, but not on whether the demonstrated benefits outweigh the known risks.
He notes the concerns that other FDA members have expressed over Addyi, acknowledging their feelings about everything from known side effects to ones that still remain up in the air. Still, he says, "In summary, I conclude that flibanserin has a positive benefit/risk assessment."
Joffe then puts the onus on proper drug labeling and drug screening technologies that will help offset any potential risks. That way, consumers can't say they haven't been warned. When in doubt, shuffle every last unresolved finding and questionable health risk into the fine print, burying it deep in loopholes and hard-to-decipher pharma lingo.
For those who are interested, Addyi was associated with "only" one death. The memo states:
The only death reported in a flibanserin-treated patient occurred in a 54 year-old postmenopausal woman with asthma, hypertension and hyperlipidemia who died 14 days after starting flibanserin 100 mg at bedtime. She was found unresponsive lying face down on her bed. The autopsy reported the cause of death as acute alcohol intoxication, and also noted coronary artery disease, with a 65 to 70% stenosis of her left anterior descending coronary artery.
Sure, it would appear that other health issues were present in the woman, but given that alcohol interaction is largely an unknown regarding Addyi, how can anyone know for sure the degree in which the drug did or did not play a role? Even an FDA press release says that "Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies."
Increase libido naturally -- why risk your health with a pill?
As with any pill, liquid or cream, whether it's to diminish stomach acid, boost libido or anything in between, why risk your health? Instead of turning to an unknown that has already proven to yield various health concerns expressed by experts -- as is the case with Addyi -- consider natural alternatives.
When it comes to increasing sexual desire, certain foods have been shown to help both men and women. Oysters, black raspberries, almonds, oatmeal and watermelon are just a few healthy foods that experts have associated with increasing libido naturally.
Sources for this article include:
Bloomberg.com
AccessData.FDA.gov[PDF]
FDA.gov
Blogs.NaturalNews.com
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