The FDA should require drugmakers to warn patients of potential long-term sexual side effects from a certain class of antidepressants, the consumer advocacy group Public Citizen argued in a new lawsuit against the agency.
In the five-page complaint filed Monday in the US District Court for the District of Columbia, Public Citizen argued that the FDA should have already decided on a citizen petition filed by a group of doctors. The petition asked the agency to require drugmakers to include information about sexual side effects of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) that can occur even after a person stops taking the medications.
Public Citizen argued that while the agency requires labels to include warnings about disruptions to sexual functioning while on the drugs, it doesn’t require drugmakers to include information about persistent or worsening effects after stopping treatment.
“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,” Antonei Csoka, one of the scientists who submitted the petition, said in a statement.
Under federal law, the FDA is required to issue a response to citizen petitions within 180 days of filing. The agency submitted an interim response in November 2018, but has yet to make a final decision. The FDA declined to comment to Endpoints News on Friday.
Regulatory agencies in Canada and Europe have taken steps to require the warning on SSRIs after receiving similar petitions, the lawsuit says.
Public Citizen is asking the court to force the FDA to respond to the citizen petition within 30 days of a court order.
“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, Public Citizen’s lead counsel on the case. “The FDA’s failure to act exposes consumers to potentially lifelong harm.”