UK Strengthens Antidepressant Warnings While FDA Continues to Lad Behind
CCHR Continues Its Decades-Long Fight to Hold the FDA Accountable for Psychiatric Drug Risks
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is requiring clearer warnings about the risk of suicidal thoughts and behaviors in antidepressant users of all ages, along with warnings about persistent sexual dysfunction that can continue long after the drugs are discontinued.
Once again, history repeats itself, with UK drug regulators taking action while the U.S. FDA lags behind.
In 2003, the UK’s MHRA was the first to warn of increased suicide and self-harm risks associated with SSRI antidepressants in young people. This prompted the FDA to finally act in 2004, despite having possessed evidence of these risks for decades. Even today, the FDA’s black-box suicidality warning identifies increased risk only through age 24—as though the danger magically disappears on one’s 25th birthday. The FDA has also yet to require a specific warning about Post SSRI Sexual Dysfunction (PSSD).
CCHR has been fighting to expose these risks for more than 35 years. Beginning in the late 1980s, CCHR received hundreds of reports of severe adverse reactions to Prozac, including agitation, suicidal ideation and violence. CCHR responded with a Citizen Petition, pressed for FDA scrutiny and helped bring these concerns before a 1991 FDA advisory committee hearing, where patients and families testified about devastating consequences.
?When the FDA failed to fully disclose its safety records, CCHR pursued Freedom of Information Act requests and sued the agency, challenging the withholding of critical information. Internal manufacturer documents revealing serious safety signals would not become public until years later.
CCHR fought to expose it. Yet decades later, American patients are still waiting for the FDA to fully acknowledge and warn about these drug risks. For decades, CCHR has continued to bring pressure to bear on the FDA, demanding full disclosure of psychiatric drug risks and accountability for regulatory failures. History has shown that it is public pressure, not regulatory benevolence, that drives the FDA to issue psychiatric drug safety warnings.
CCHR will continue that fight – with your help.
Please continue to support the cause.