From Maryanne Demasi Reports: “In 2018, a group of physicians and researchers petitioned the FDA to ‘immediately require the addition of boxed warnings and precautions [about Post-SSRI Sexual Dysfunction (PSSD)]’ on the drug labels and asked that ‘Dear Doctor’ letters be issued to prescribers to warn of such risks.
‘Even though the risk of PSSD may be rare, the condition is severe enough to sway someone’s decision to take the drug,’ said [psychiatrist Josef] Witt-Doerring.
‘They might have mild depression and decide they’ll do talk therapy instead of taking the small risk of permanent sexual dysfunction. It’s important for people to have informed consent,’ he added.
While the true rate of harm is unknown, a 19-year retrospective cohort analysis published last year, found 1 in 216 males taking a serotonergic antidepressant (80% took an SSRI) experienced erectile dysfunction long after discontinuing the drug.
US law requires the FDA to respond within 180 days of receiving a petition, but it has been six years and the agency has remained silent.
This week, Public Citizen filed a lawsuit, on behalf of Dr Antonei Csoka, PSSD researcher and scientific advisor for the PSSD Network, which alleges 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.
‘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 and lead counsel. ‘The FDA’s failure to act exposes consumers to potentially life-long harm.'”
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