MEDICATION REGULATORS

Please click on the images below to view the regulator statements

European Medicines Agency - EMA

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

Health Canada

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

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.

Therapeutic Goods Administration - TGA

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

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

Food & Drugs Administration - FDA

Despite the other drug regulators adding persistent sexual dysfunction into their side effect labels, the FDA is currently battling a lawsuit in 2024 after ignoring the 2018 petition to have this added. We will update you as soon as this lawsuit is settled.

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.