Female Sexual Dysfunction is a real thing and it is about time there should be medications available for it. Females suffer from sexual dysfunction as much as men do. There are a lot of medications available in the market to cure erectile dysfunction, but until long there was no medication available to treat sexual dysfunction in females.
The first drug to be invented to treat sexual dysfunction in premenopausal women, commonly called “Female Viagra” has finally been approved by the United States Drug and Food Administration. It goes by the medical name Flibanserin.
Flibanserin has been legalized by the Food and Drug Association to treat reduced sex drive in premenopausal women.
This medicine is manufactured by a manufacturing body known as Sprout Pharmaceuticals. In some parts it is also sold under another brand name known as Addyi. This drug has been approved by the general drug agency to be used for the treatment of sexual disorders which are found in women. It is a condition that is characterized by a reduced sex drive. There is an approx. estimation that around one in every ten women suffer from hypoactive sexual desire disorder and 40% of the females struggle with these conditions at least one in some stage of their life. A lot of factors can be accounted for reduced sex drive in women like low self-esteem, some mental health problems, hormonal factors as well as some physical factors like lifestyle habits or fatigue.
It is still unclear how the medicine affects the female’s body but Sprout Pharmaceuticals believes that the medicine works by correcting the balance of a chemical present in the brain that is responsible for sexual arousal. According to the United States, Food And Drug Administration a 100 mg dose of Flibanserin can be daily once every night before going to bed. However, if there is not an improvement in sexual desire even after taking the medicine for over 8 weeks, it should be discontinued.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Association said “Today’s approval provides women distressed by their low sexual desire with an approved treatment option”
She continued by saying “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction”
Since the medication is new and the mechanism of the medicine is still pretty unclear, Flibanserin should only be prescribed by certified pharmacies and healthcare professionals.
The Food and Drug Association reached the decision of approving the medication basis some analysis that they conducted. The Food and Drug Association conducted three randomized, placebo-controlled, double-blind trials that involved 2400 women. The average age of these women was 36 years old and all of them had hypoactive sexual desire disorder.
For a period of 24 weeks all the 2400 hundred women either to placebo or a 10 mg dose of flibanserin before going to bed. Women who were taking Flibanserin were reported to have experienced a high sex drive which enables them to engage in sexual behavior with people on a daily basis. This lead to the overall increase in the sexual behavior of the person.
They also reported a decrease is distress that was caused due to reduced sex drive.
On assessing the safety of the medication, the Food and Drug Association reported that the most common side effects caused due to taking the medication are dizziness, nausea, insomnia, dry mouth, and fatigue. Apart from these side effects, the FDA has also associated the drug with hypertension, loss of consciousness and severely low blood pressure when taken along with alcohol. Because of these adverse side effects, the Food and Drug Association had rejected this drug twice- once in 2010 and one again in 2015.
There is a risk factor which is associated with the FDA regarding their mitigation strategies. These bodies have to make sure that there is a complete training program given to the patients before going out and prescribing this medicine to the mass.
According to Dr. Woodcock having a high interaction with alcohol can make the treatment of Addyi confined to the professionals. It is important for both the prescribers as well as the patients to learn and know the risks that are associated with this drug
In addition to this, medicine comes with a warning outside the box. This drug can come with side effects such as concussion and hypertension if consumed with Alcohol.
The warring states the risks of hypertension and concussion if the drug is taken along with alcohol. This drug also comes with a major warning for patients with impaired liver. There is also a protocol for FDA to run three well-defined tests which can help them to analyze the side effects caused by this drug in a better way as well as the interaction.
Food and Drug Associations approval for Flibanserin has received mixed reactions overall. There are some people who have welcomed the drug with open arms but at the same time, there are people who have raised their concerns with the side effects related to the drug.
Back in June, a Spotlight from Medical News Today scrutinized the pros and cons of Flibanserin and whether the medicine was effective to treat reduced sex drive in women or not.
There are many women assistant professors at the University of Victoria who were not convinced with the efficacy of the drug and that it helps in increasing the sexual desire of a woman.
She was not convinced that evidence supporting the safety of the drug was enough to get approval from the Food and Drug Administration. She was convinced that the drug is not as effective as it claims and at the same time she had full faith on the FDA that it will not approve the medicine and in case they do, it can be coined very dangerous to them.
Despite the fact that Food and Drug Associations approval comes with evidence reflecting the safety of the drug, there are a lot of doctors and researchers who have criticized the FDAs decision of approving the medication. Some even said that “it is a sad day for drug regulation”
The views on legalizing medicine are very polar. Even though the medicine has been approved, it hasn’t received a 100% acceptance by society.
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