FDA Sued Over Inaction on Citizen Petition
Drugs Have Been Linked to Long-Term Sexual Dysfunction
WASHINGTON, D.C. — Public Citizen today filed a lawsuit against the U.S. Food and Drug Administration (FDA) for its inaction on a petition requesting that the FDA require the revision of product labels for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). The requested revision seeks to warn of the drugs’ risk of serious sexual side effects, which may persist after stopping SSRI or SNRI treatment, and may even be permanent. Although the petition was filed six years ago, the FDA has neither granted nor denied it.
Public Citizen represents Dr. Antonei B. Csoka, one of the scientists who submitted the citizen petition. Dr. Csoka has been researching Post-SSRI Sexual Dysfunction (PSSD) since 2004. He is a scientific advisor to the PSSD Network, a non-profit advocacy organization that seeks to increase awareness of PSSD, encourage research into potential treatments and cures, and offer support to patients.
SSRIs and SNRIs are prescription drugs approved by the FDA to treat clinical depression and certain other conditions. SSRIs include citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), and vortioxetine (Trintellix). SNRIs include desvenlafaxine (Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor). SSRIs and SNRIs are known to cause adverse sexual effects, and current product labeling in the United States warns of disturbances to sexual functioning during treatment with SSRIs and SNRIs. The labeling does not currently convey the risk of persistent, worsening, or new symptoms of sexual dysfunction after stopping use of those drugs.
“Without adequate warnings about the risk of potentially permanent damage to sexual function, patients and health care professionals cannot weigh the benefits of the drugs’ use against the potential harms,” explained Dr. Csoka.
The petition requests that the FDA require the revision of SSRI and SNRI product labeling to warn of the risk of sexual side effects that may persist after discontinuation of the drug. The petition also requests that the FDA require the issuance of a “Dear Health Care Provider Letter” that would inform those who prescribe SSRIs and SNRIs of such risks, and to develop a medication guide and communication plan to make patients aware of the risk.
After receipt of similar petitions in 2018, the drug regulatory agencies in Europe and Canada acted to warn patients and health care professionals of the risk that sexual side effects may persist after stopping SSRI or SNRI treatment. In 2019, the European Medicines Agency adopted product information updates to warn that SSRIs and SNRIs may cause long-lasting sexual dysfunction that may continue despite discontinuation of treatment. In 2021, Health Canada completed a safety review and announced updates to the labeling and product safety information for SSRIs and SNRIs to reflect the risk.
“The FDA needs to act in a timely way to inform the public about the risks associated with use of these drugs,” said Michael Kirkpatrick, an attorney with Public Citizen Litigation Group and lead counsel on the case. “The FDA’s failure to act exposes consumers to potentially life-long harm.”
The lawsuit filed today in the U.S. District Court for the District of Columbia alleges that the FDA has behaved unlawfully in failing to act on the petition, and it asks the Court to order the FDA to issue a decision on the petition. The complaint is available here.