A nonpartisan consumer advocacy organization on Monday filed a lawsuit against the U.S. Food and Drug Administration (FDA) for its inaction on a petition concerning serious sexual side effects of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) type antidepressants.
The petition requested the FDA to require the revision of product labels for the two types of prescription drugs and was filed by a group of 22 physicians and scientists on May 10, 2018—just over six years ago.
Public Citizen is now suing the FDA for having neither granted nor denied the petition since when FDA regulations require the agency to issue “a response to each petitioner within 180 days of receipt,” Public Citizen said in a statement.
“SSRIs and SNRIs are known to cause adverse sexual effects,” the consumer advocacy organization said in statement. Though these side effects are mentioned on the current product labeling, no mention is made that “sexual side effects may persist, worsen, or begin after stopping SSRI or SNRI treatment,” the lawsuit states.
“Current labeling in the United States does not adequately convey the risk of broad, severe, and potentially permanent post-treatment changes to sexual function.”
The petition also called upon the FDA to require manufacturers to include a “Dear Health Care Provider Letter” that would inform those who prescribe the drugs of the serious adverse reactions associated with their use during and after treatment and further requested the development of a medication guide and a communication plan to make patients aware of the risks involved.
According to the lawsuit, the petition summarized the scientific literature regarding Post-SSRI Sexual Dysfunction or PSSD, which suggests that adverse sexual effects may occur not only after prolonged use but even after a short period of time. These reactions may emerge or worsen after the treatment is ended and may, in some cases, persist for years or even be irreversible.
“Without adequate warnings about the risk of potentially permanent damage to sexual functioning, patients and health care professionals cannot weigh the benefits of the drugs’ use against the potential harms,” the court filing reads.
According to the PSSD Network non-profit, common symptoms of PSSD include genital numbness, a complete loss of libido, erectile dysfunction, vaginal dryness, etc.
According to the Canadian PSSD Society, “the causes of PSSD are poorly understood and there are no known reliable treatments.”
Similar petitions to the one filed with the FDA were submitted to drug regulatory agencies in Europe and Canada in 2018. The European Medicines Agency adopted product information updates in 2019, warning of PSSD risk; Health Canada followed suit in 2021.
“The FDA has unreasonably delayed issuing a decision in light of the nature and extent of the public health interests addressed in the petition,” the lawsuit alleges.
With the lawsuit, Public Citizen is seeking a court order requiring the FDA to issue a decision on the petition, as well as a declaration that the FDA has violated the Administrative Procedure Act by withholding action.
NTD reached out to the FDA for comment but did not receive a response by press time.
