FDA Faces Lawsuit Over Failure to Add Sexual Side Effects Warnings to Certain Antidepressants

Canadian and European regulators have already added long-term sexual dysfunction warnings to antidepressants like Lexapro and Effexor, but the consumer watchdog Public Citizen indicates that FDA has failed to do so.

The U.S. Food and Drug Administration (FDA) faces a lawsuit brought by the prominent consumer watchdog group Public Citizen, indicating that the agency has failed to add sexual dysfunction side effects warnings to popular antidepressants, like Lexapro, Prozac and Effexor.

The complaint (PDF) was filed in the U.S. District Court for the District of Columbia on Monday, on behalf of Dr. Antonei B. Csoka, who filed an FDA petition together with Public Citizen in May 2018, calling for the agency to add new warnings about the potential sexual side effects of antidepressants that are part of selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) classes of medications.

SSRI and SNRI drugs are widely prescribed to treat clinical depression throughout the U.S. and the world. However, Public Citizen argues the drugs are known to cause adverse sexual side effects. While current labels do include some warnings of disturbances to sexual functioning during treatment, the labels do not warn patients that those side effects may persist even after they have stopped taking the drugs.

The 2018 petition was filed by Public Citizen and a group of researchers that included Csoka, who is in charge of the Epigenetics Laboratory at Howard University College of Medicine in D.C. He and the other petitioners requested that the FDA revise the SSRI and SNRI drug labels to warn about the risk of SSRI and SNRI sexual side effect persistence, but only received an “interim response” from the FDA in November 2018.

The lawsuit indicates that the FDA failed to meet federal regulations that require a full response to each petitioner within 180 days. The interim response from the FDA only indicated that it had not yet reached a decision due to the complex issues involved.

Public Citizen notes that while the U.S. took no action to warn patients about the potential risks, regulators in Canada and Europe did.

“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 lawsuit states. “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 charges the FDA with violating the Administrative Procedure Act, and asks the court to require the FDA to issue a decision on the petition.