“Female Viagra” May Get Approved by FDA This Week Flibanserin, a drug designed to increase libido in women also known as “female Viagra”, could be approved by the U.S. Food and Drug Administration this week. FDA approval of the “female Viagra” would be unprecedented, as no such drug has ever been approved before. WHAT IS FLIBANSERIN? Unlike Viagra, flibanserin aims to raise libido by targeting the female brain's pleasure center instead of the genitals. Proponents of the cite the lack of a female equivalent to Viagra. Unlike men, there is no drug on the market to combat persistent low sexual desire in women, a condition also known as hypoactive sexual disorder (HSDD). But critics of flibanserin say that the negative side effects associated with the drug are too large for it to be released. …show more content…
And aside from these side effects, opponents of the drug say that the cause of HSDD can be psychological, not physical. For these reasons, flibanserin was rejected by the FDA drug safety advisory committee in 2010 and 2013. Despite these concerns, it is likely that flibanserin will receive FDA approval this week. The drug was passed in June (with the condition that the manufacturer take measures to limit safety risks) by the drug safety advisory panel, which it usually follows in approval. As Liz Szabo of USA Today reported, flibanserin manufacturer Sprout Pharmaceuticals has supported a large public relations campaign to get the the pill passed. It appears to be quite successful: 11 members of Congress and the National Organization for Women have written to the FDA in support of the drug. EXPERTS AGAINST THE FEMALE
Carl Djerassi was a chemist in Mexico city that created the first pill that synthesized hormones in 1951. In 1957 the FDA approved the pills for women with menstrual disorders but just three years later the pill was released for sexual protection. Some states still made this drug illegal and it went against many people’s morals. In 1997 the pill was expanded to treat acne (A Brief History 1-2). The pill has come a long way and is still continuing to form in this evolving society. Less than seventy years ago we didn’t even have an oral option for birth control. Today we are fighting over whether the pill can be available over the counter or not.
Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.
The health issues listed here are just a glance at what this drug can do to one’s health.
Many Americans continue to believe that if a medication has been approved by the FDA it is safe for us to use, but the facts are many times they are not. You only have to look at all the medications that have been pulled from the market after many people lost their lives or had their health decay from these medications to know that nothing could be further from the truth. It helps to find a physician who will tell you to change your lifestyle rather than prescribe a pill that might have harmful side effects.
Syntex, Parke Davis and Ortho pharmaceutical firms had introduced their own oral contraceptives to the market, and others were awaiting approval by the Food and Drug Administration. Used by over 6.5 million women, the birth control pill had become the most commonly used form of contraception in the nation.
To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.
After a series of successful medicine permitted for the erectile disfunction or the so-referred to as impotence(we could take as an instance Sildenafil, known as "viagra, offered for the reason that 1998 and Vardenafil, also called "Levitra", observed in pharmacies seeing that late August 2003), an extra remedy was created so as to entire the form of those merchandise and allow persons to opt for: this today's remedy is tadafil (its industrial identify is Cialis and could were purchased on account that November 2003).
quest to get a “female arousal” drug approved by the FDA and put out to the market. As Canner
Blog Male birth control pill moves a step closer16th August 2012Researchers have finally found a compound that may offer the first effective and hormone-free birth control pill for men.The study, published today in the journal Cell, describes how the small molecule makes male mice reversibly infertile, without putting a damper on their sex drive. When the animals stop taking this new form of birth control, their sperm rebound and they are able to produce perfectly healthy offspring once again."This compound produces a rapid and reversible decrease in sperm count and motility with profound effects on fertility," said James Bradner of the Dana-Farber Cancer Institute and lead author of the study.A male birth control
The pharmaceutical field has overcome countless medical feats since the early times. While “the pill” itself was considered a brand new invention, the idea of creating a birth control pill was not. Since the old times primitive condoms were made from animal intestines and fish bladders. However, it wasn’t until after Margaret Sanger’s multiple convictions and persistent attitude, that a judge ended the Comstock era, providing Sanger with the opportunity to stress the importance of having birth control in th for of a pill to the public.
There are currently none in the marketplace for females. Sprout prescription drugs is the state-of-the-art in a line of corporations hoping to change that. Sprout intends to market its product flibanserin, described as a medication for females with hypoactive sexual desire ailment, beneath the brand title Addyi if the FDA approves it. After two earlier rejections, the drug's possibilities seem brighter this time; an advisory panel previous this month informed the FDA to maneuver ahead with approval. Although the FDA need not follow the panel's recommendation, the company more often than not does
he US-FDA, on 18th August, 2015 approved the drug Flibanserin (brand name Addyi) for the treatment of acquired, generalised Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Addyi is being dubbed as the "Female viagra" and "the little pink pill".
Nevertheless, some side effects of the medication are severe and need immediate medical intervention, left untreated; they can lead to serious complications. So, check with the physician if any of these undesired effects occur:
Both the Advanced Medical Technology Association and the Pharmaceutical Research and Manufacturers of America have thrown their full support behind the legislation. According to the industry groups, the bill would make the FDA's review process more efficient and less burdensome by reducing the costs of marketing products and lowering the cost of new medicines and devices for patients.
This paper looks to discuss and expand on a news article and two other published articles which report on the lack of Federal Drug Administration (FDA) approval for a sildenafil drug or “female Viagra”. The articles remain constant in the description of what this drug would provide for women. However, they differ in describing the reasons why a drug has not been approved so far. For example, Thielen believes that efforts in the past have been rejected because of concerns relating to the possible side-effects that would come with a drug that would treat female sexual dysfunction (Thielen, 2014). Sifferlin also agrees that there must be more Federal Drug Administration (FDA) research before a pill will be widely accepted (Sifferlin, 2014). Also she feels that female sexual dysfunction is more complex than that with male sexual dysfunction because most cases are due to daily life stressors rather than a biological dysfunction (Thielen, 2014). Dvorak disagrees with this entirely and believes that these generalizations made about women and the reasons for their lack of sexual desire having to do with emotions are because of gender stereotypes and rigid, antiquated gender roles (Dvorak, 2014). This paper examines Dvorak’s claims about gender inequality and how it is affecting the lack of options for women when it comes to treating sexual dysfunction