Capsaicin

As a result of treatment-related increases in pain, transient increases in blood pressure (on average <8.0 mm Hg) may occur during and shortly after the capsaicin treatment. Blood pressure should be monitored during the treatment procedure. For patients with unstable or poorly controlled hypertension or a history of cardiovascular disease, the risk of adverse cardiovascular events due to the potential stress of the procedure should be considered prior to initiating capsaicin treatment. Particular attention should be given to diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.

There are no or limited amount of data from the use of capsaicin in pregnant women. Based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin, the likelihood that capsaicin increases the risk of developmental abnormalities when given to pregnant women is very low. However, caution should be exercised when prescribing to pregnant women.

It is unknown whether capsaicin/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of capsaicin/metabolites in milk.

A risk to the newborns/infants cannot be excluded.

Breast-feeding should be discontinued during treatment with capsaicin.

Fertility

There is no data in humans available on fertility. A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies.

Capsaicin has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Of the 1826 patients treated with capsaicin in randomized controlled trials, 1089 (59.6%) reported adverse reactions considered related to the medicinal product by the investigator. The most commonly reported adverse reactions were transient local application site burning, pain, erythema and pruritus. Adverse reactions were transient, self limiting and usually mild to moderate in intensity. In all controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving capsaicin and 0.9% for patients receiving control.

List of adverse reactions

In the list below all adverse reactions, which occurred at an incidence greater than control and in more than one patient in controlled clinical trials in patients with postherpetic neuralgia (PHN), painful Human Imunodeficiency Virus – Associated Neuropathy (HIV-AN) and painful diabetic peripheral neuropathy, are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Tabulated list of adverse reactions:

Infections and infestations

Uncommon: Herpes zoster

Nervous system disorders

Common: Burning sensation

Uncommon: Dysgeusia, hypoaesthesia

Eye disorders

Uncommon: Eye irritation

Cardiac disorders

Uncommon: First degree atrio-ventricular (AV) block, tachycardia, palpitations

Vascular disorders

Uncommon: Hypertension

Respiratory, thoracic and mediastinal disorders

Uncommon: Cough, throat irritation

Gastrointestinal disorders

Uncommon: Nausea

Skin and subcutaneous tissue disorders

Uncommon: Pruritus

Musculoskeletal and connective tissue disorders

Common: Pain in extremity

Uncommon: Muscle spasms

General disorders and administration site conditions

Very common: Application site pain, application site erythema

Common: Application site pruritus, application site papules, application site vesicles, application site oedema, application site swelling, application site dryness

Uncommon: Application site urticaria, application site paraesthesia, application site dermatitis, application site hyperaesthesia, application site inflammation, application site reaction, application site irritation, application site bruising, peripheral oedema

Investigations

Uncommon: Increased blood pressure

Injury, poisoning and procedural complications

Not known: Burns second degree, accidental exposure (including eye pain, eye and throat irritation and cough)

Description of selected adverse reactions

Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the capsaicin application site in clinical trials with healthy volunteers.