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Glossary: PSSD, PFS, PAS and medicine labels

Plain definitions of the words on this site: PSSD, PFS and PAS, the medicines, the official texts, the regulators and the MedDRA terms.

These are the words this site uses for the conditions, the medicines and the official texts about them. Each one has a short definition and, where a fact rests on it, a link to the source.

Every term has an address of its own: the address of this page, then # and the term’s name, such as #pssd. The names are the same in every language and do not change.

Post-drug syndrome

A post-drug syndrome continues, or first appears, after a medicine is stopped, and it can last for months or years. ‘Post-drug syndrome’ is the umbrella term SIDEfxHUB uses for conditions such as PSSD, PFS and PAS; it is not an established diagnosis.

PSSD (post-SSRI sexual dysfunction)

Post-SSRI sexual dysfunction (PSSD) is a multisystem condition caused by SSRI and SNRI antidepressants. It can affect sexual function, emotions, cognition and the senses.

PFS (post-finasteride syndrome)

Post-finasteride syndrome (PFS) is a multisystem condition caused by finasteride and related drugs. It can affect sexual function, mental health and cognition, and erode the male body.

PAS (post-Accutane syndrome)

Post-Accutane syndrome (PAS) is a multisystem condition caused by isotretinoin, an acne medicine sold as Roaccutane in the UK and formerly as Accutane in the US. It can affect mental health, sexual function, cognition and the body.

5-alpha-reductase inhibitor

A medicine that blocks 5-alpha-reductase, an enzyme that turns testosterone into DHT. Finasteride, used for hair loss and an enlarged prostate, and dutasteride are 5-alpha-reductase inhibitors.

Anhedonia

Being unable to feel pleasure. The 2022 diagnostic criteria for PSSD include a lasting decrease in the pleasure felt during orgasm.

Data sheet (New Zealand)

The official text on a medicine in New Zealand. Medsafe, the New Zealand medicines regulator, publishes data sheets on behalf of the companies, with a leaflet for patients called Consumer Medicine Information.

DHPC (direct healthcare professional communication)

A letter from the company that holds a medicine’s licence, telling health professionals about important new safety information and any action to take. In the EU, some are agreed with the regulators first.

Drug Safety Update

The MHRA’s safety updates on medicines in the UK, with advice for health professionals.

EMA (European Medicines Agency)

The European Union’s agency for medicines. It assesses medicines and supervises and monitors their safety in the EU.

Emotional blunting

Feeling emotions less strongly than before, also described as feeling emotionally numb. The NHS lists feeling emotionally numb among common side effects of antidepressants, and the 2022 PSSD criteria name emotional numbing as a possible non-sexual symptom.

FDA (US Food and Drug Administration)

The United States’ medicines regulator. It is responsible for making sure that medicines there are safe and effective.

Genital numbness (genital anaesthesia)

Reduced or lost feeling in the genitals. The 2022 diagnostic criteria for PSSD require a lasting change in genital sensation after the medicine is stopped.

Isotretinoin

A medicine taken by mouth for severe acne, sold as Roaccutane in the UK. It belongs to the retinoids, a group of medicines used mainly for skin conditions.

Marketing authorisation holder

The company, or other legal body, that holds the licence to sell a medicine.

MedDRA

The Medical Dictionary for Regulatory Activities: the international medical terminology that regulators and companies use to code reports of side effects. PSSD has a term in it, ‘Post-SSRI sexual dysfunction’ (10086208), and so does PFS, ‘Post 5-alpha-reductase inhibitor syndrome’ (10082430); there is no term for PAS yet. These terms are for reports of side effects, not diagnoses: none of the three conditions has a code of its own in ICD-11, the WHO’s classification used to record diseases.

Medicines regulator

The public body that assesses medicines and watches over their safety in a country or region, such as the MHRA in the UK and the EMA in the EU.

MHRA (Medicines and Healthcare products Regulatory Agency)

The UK’s medicines regulator. It regulates medicines and medical devices in the UK and runs the Yellow Card scheme.

Package leaflet

The leaflet in the pack of a medicine, written for the person who takes it.

PRAC (Pharmacovigilance Risk Assessment Committee)

The EMA’s committee that assesses and monitors the safety of medicines. In May 2019 it recommended new wording on lasting sexual problems after stopping for ten SSRI and SNRI antidepressants.

Prescribing information (United States)

The FDA-approved text on a medicine in the United States. With the texts for patients and the labelling on the pack, it makes up the medicine’s label, which sums up the essential scientific information needed to use the medicine safely and effectively.

Product information

The officially approved texts about a medicine, for health professionals and for patients. In the EU they are the SmPC, the package leaflet and the labelling on the pack.

Product monograph (Canada)

The official text on a medicine in Canada: a factual, scientific document that describes its properties and conditions of use. It has a part with information for health professionals and a part for patients.

Reporting a side effect

Telling a medicines regulator about a problem you think a medicine caused. In the UK anyone can report to the Yellow Card scheme, which the MHRA runs.

SmPC (Summary of Product Characteristics)

The official text on a medicine for health professionals in the UK and the EU. It describes the medicine and the approved conditions of its use.

SNRI (serotonin-noradrenaline reuptake inhibitor)

A type of antidepressant. Duloxetine and venlafaxine are SNRIs.

SSRI (selective serotonin reuptake inhibitor)

The most widely used type of antidepressant. Sertraline, citalopram, escitalopram, fluoxetine and paroxetine are SSRIs.

Withdrawal symptoms

Symptoms that can start when a medicine is stopped or its dose lowered, such as dizziness or sleep problems. For antidepressants the NHS says they usually last a few weeks, and for some people months or longer.