For the first time in history, the U.S. Food and Drug Administration (FDA) has approved a new drug called Addyi to assist in boosting sexual desire in women. People are calling it the “Viagra for women” though it operates quite differently than Viagra. Unlike Viagra, which treats erectile dysfunction by increasing blood flow, Addyi – also chemically known as Flibanserin – treats hypoactive sexual desire disorder (HSDD) by tackling chemical imbalances in the brain. Additionally, Addyi must be taken regularly to obtain the desired effect while Viagra need only be ingested before a sexual encounter.
A Breakthrough or a Liability
Addyi is considered to be revolutionary in the pharmaceutical world, since millions of women in the United States suffer from HSDD. Medical professionals also support the new drug, calling it the biggest breakthrough in women’s health since the birth control pill. However, the FDA rejected the drug’s previous versions due to potentially dangerous side effects.
Critics of Addyi say that in the big picture, the risks of taking the drug outweigh the trivial effect. During trials, participants compared the drug to placebos and reported that they experienced an increase of only one additional satisfying sexual experience per month. On the other hand, potential side effects include nausea, fainting and low blood pressure. Users are also advised not to drink alcohol at all while taking the drug, because it will increase the severity of the side effects. Nevertheless, some women who participated in the trial thought that the effect was worth the physical risks and suspended alcohol use.
Due to its risks, Addyi will only be distributed through the prescription of specially certified prescribers who have completed a risk evaluation and mitigation strategy training (REMS). Prescribers will be required to inform patients on the risks of the drug before distributing it, and pharmacies will be prohibited from supplying the drug to patients without a prescription from a REMS certified prescriber.
In addition, the drug will come with a warning label on the box indicating the serious risks of abnormally low blood pressure and loss of consciousness, especially when consuming alcohol or taking CYP3A4 inhibitors. It will also warn against use by patients with liver impairments.
Dangerous Drug Attorneys
Although the FDA’s approval of Addyi indicates that it is safe for general public use, it is not guaranteed that injury will not occur. New drugs always come with risks, especially when potential side effects and reactions have yet to be discovered. Attorneys at Solomon Law Group have experience in holding pharmaceutical companies and medical professionals accountable on behalf of patients who have been injured by dangerous drugs. Our attorneys include an active member and affiliate of state and national attorney groups that monitor medical pharmaceutical activity. If you are planning on taking this drug, be wary of the risks involved and make sure that you are fully informed of the side effects by certified medical professionals. In the dreadful event that injury does occur, our lawyers will be here to help.
