The U.S. Food and Drug Administration (FDA) has a reputation as an organization firmly devoted to the safety and protection of consumers from the ravishes of unsafe and unchecked pharmaceuticals and other products entering the consumer market. Although they take this duty very seriously, they must also make allowances for new medications or products to […]
The U.S. Food and Drug Administration (FDA) has a reputation as an organization firmly devoted to the safety and protection of consumers from the ravishes of unsafe and unchecked pharmaceuticals and other products entering the consumer market. Although they take this duty very seriously, they must also make allowances for new medications or products to tentatively enter the market. Usually when these type of allowances are made, however, the manufacturer or producer often must conduct long-term studies that follow a series of strict FDA regulations to ensure the long-term efficacy and safety of a product. To the dismay of many though, Sprout Pharmaceuticals is in hot water with the FDA recently as their protection of their hypoactive sexual desire disorder medication: Addyi has raised some ethical concerns. While all companies stand by their products, Sprout’s protective measures have some outlets calling attention to the Addyi controversy surrounding potential side effects and alcohol.
Hypoactive Sexual Desire Disorder (HSDD) is a condition with a multitude of symptoms related to decreased libido and desire in premenopausal women that cause the patient emotional and mental distress. The American Sexual Health Association (ASHA) states that HSDD can be caused by physical symptoms, like breast cancer, thyroid problems, or multiple sclerosis; psychological conditions; relationship troubles; or a chemical imbalance in the brain.
While this condition is still being researched in order to properly understand its various incarnations, the only medical solution currently approved by the FDA is flibanserin, known by its brand name: Addyi. Produced by Sprout Pharmaceuticals, Addyi is the only medication for treating HSDD but has experienced some pushback from the FDA regarding the concealment of the risks and prevalence of Orthostatic Hypotension (low blood pressure that occurs when transitioning from sitting/lying back to standing) and syncope (fainting or loss of consciousness). This concealment has led some to accuse Sprout Pharmaceuticals of perpetuating an Addyi controversy.
In a letter exchange, the FDA describes several attempts of Sprout to be less than forthcoming in acknowledging the connection between Addyi, alcohol, and several adverse effects including hypotension and syncope. This denial comes in spite of the results of Sprout’s own FDA-mandated in-house study. Sprout claims that no hypotension or syncope occurred in women who took Addyi while consuming alcohol during the study.
Dr. Julie Beitz, M.D., Director of the Office of Drug Evaluation III at the FDA Center for Drug Evaluation and Research rebutted Sprout’s conclusion in the FDA’s response letter by reminding the Sprout executives that no information about Orthostatic Hypotension or syncope was recorded in the study because most of the women in the study were prevented from engaging in certain risky behavior because the study’s safety precautions forbid them from entering situations that would knowingly result in those symptoms occurring. One of the situations that subjects were protected from was being forced to stand after drinking alcohol and taking Addyi. This action was forbidden because subjects reported feeling lightheaded and gave researchers ample belief that standing would immediately trigger either orthostatic hypotension or outright syncope.
Though expressing sentiments of controversy can seem presumptuous, from an initial report on February 27, 2018, until the most recent response on April 11, 2019, Sprout Pharmaceutical has sent a dozen letters attempting to omit the warnings about the full dangers of Addyi when mixed with alcohol. Those letters were cited in Dr. Betiz’s letters as being sent on the following dates:
Throughout this period, the FDA and Sprout Pharmaceuticals have gone back and forth on the appropriateness of the black box labeling of Addyi. With no clear resolution by mid-March, the FDA decided to take further steps.
On April 11, 2019, the letter previously described, written by Dr. Beitz was sent to Sprout Pharmaceuticals along with a final ultimatum designed to put an end to this Addyi controversy over labeling: Sprout Pharmaceuticals has until April 26, 2019, to ensure the FDA receives an altered black box warning that meets the requirements laid out in their final form 2 months prior. Failure to comply with this request will result in upwards of a quarter of a million dollars in fines being levied at Sprout. The corporation could also file a formal complaint, but as of the time of this article, the deadline, April 16, has passed and the FDA has not updated their announcement page. Dr. Julie Beitz was cited in the FDA’s press announcement defending the FDA’s choices saying:
“We recognize that women want access to treatments for female sexual dysfunction, and we are committed to helping ensure approved therapies are safe and effective when taken as indicated and to supporting the development of new therapeutic options for female sexual dysfunction.”
With the FDA’s support, hopefully, the Addyi controversy will be formally laid to rest and Sprout will perform with closely scrutinized transparency.
For more coverage of the FDA’s regulatory crackdowns on delinquent companies, see Parker Waichman’s coverage of proton pump inhibitors here.
While the FDA’s treatment of the Sprout Pharmaceuticals Addyi controversy is a sure win for women with HSDD going forward, many women have been wrongfully injured as a result of inadequate information regarding the safety of mixing alcohol and Addyi. Women may have suffered injurious falls, concussions, contusions, or other injuries as a result of dizziness or collapsing due to orthostatic hypotension or syncope.
If you or a loved one have experienced such an injury while taking Addyi, don’t wait. Parker Waichman LLP is ready to represent your needs in a court of law. At Parker Waichman LLP, experienced trial lawyers have brought numerous common people’s claims before corporations who have refused to acknowledge the full host of risks posed by their products to consumers. Contact Parker Waichman today for a free consultation and let our team fight for you.
