REGULATORS

Please click on the images below to view the regulator statements

European Medicines Agency logo with a blue circle and silver symbol above the agency's name.

European Medicines Agency - EMA

The EMA acknowledged and added persistent sexual dysfunction into their side effect labels in 2019.

Logo of the Health Products Regulatory Authority (HPRA) featuring a stylized circular design with shades of green and blue.

The HRPA in Ireland acknowledged and added persistent sexual dysfunction to their side effect labels for SSRIs and SNRIs following the 2019 EMA decision. In addition, they sent letters to prescribing doctors informing them of the change.

Health Products Regulatory Authority - HPRA

Logo for MHRA, featuring a circular cluster of dots in various colors and the acronym MHRA in bold blue letters.

Medicines and Healthcare products Regulatory Agency - MHRA

The UK added a basic warning to SSRIs and SNRIs in line with the 2019 EMA decision. More recently, the MHRA set up an expert working group of the Commission on Human Medicines to further look into the issue.

Canadian flag with red and white stripes and a red maple leaf, alongside the text 'Health Canada'.

Health Canada

Health Canada acknowledged and added persistent sexual dysfunction to side effect labels in 2021.

Logo of the Department of Health featuring a red human figure with outstretched arms, a red circle head, and black text in Chinese characters and English.

Hong Kong Department of Health

The Department of Health followed Health Canada’s decision and sent letters to local healthcare professionals in January 2021. In February 2022, they added persistent sexual dysfunction to their labels for SSRIs and SNRIs.

Australian Government Department of Health Therapeutic Goods Administration logo

Therapeutic Goods Administration - TGA

The TGA has acknowledged and added persistent sexual dysfunction to side effect labels in 2024.

National Pharmaceutical Regulatory Agency - NPRA

The NPRA has recognized persistent sexual dysfunction. A warning has been issued and added to side effect labels in 2025.

U.S. Food & Drug Administration logo with blue text on a white background

Food & Drugs Administration - FDA

Despite other drug regulators adding persistent sexual dysfunction into their side effect labels, the FDA battled a Public Citizen lawsuit in 2024 after ignoring a 2018 petition to recognize persistent sexual dysfunction. As of 2026, this is still hidden from side effect labels in the US.