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Research Article Open access CC BY 4.0

Post-injection Complications. Nicolau Syndrome as a Consequence of Local Irritant Effects of Drugs, Including Antiseptics, Local Anesthetics, NSAIDs, Steroids and Anticoagulants

Aleksandr Urakov, Natalya Urakova, Evgeny Fisher, Ilnur Bashirov, Sabina Nurlanova, Anastasia Klimovich, Albina Fakhretdinova, Anvar Bakirov, Regina Balametova, Aleksandr Samorodov

Journal of Pharmaceutical Research International · pp. 26–36 · Published 21 Apr 2022

10.9734/jpri/2022/v34i33A36123

Abstract

It has been shown that some drugs considered to be of good quality today can cause an iatrogenic disease known as Nicolau syndrome. Nicolau syndrome is a rare cutaneous drug reaction occurring after injection many drugs. This disease has been found to be caused by the very strong local irritant activity of drug solutions. It turned out that the standard for assessing the quality of drug solutions does not include assessment of their osmotic activity and the strength of their local irritating effect on various tissues during injection. At the same time, drug solutions produced by different pharmaceutical companies may contain, in addition to the main ingredients, other ingredients (hydrochloric acid, sodium hydroxide, propylene glycol, etc.). Very often the additional ingredients increase the osmotic activity of the drug solution, which is not controlled today, so it remains unknown.  This is why drug solutions produced by some pharmaceutical companies can have hypertonic activity, which can sometimes by ignorance reach values that are incompatible with the vital activity of human body tissue cells. Therefore, injections of such drug solutions can have a very strong dehydrating effect on the tissue cells at the injection sites, have a local irritating and cauterizing effect. It has been shown that even steroid solutions in some manufacturers may have excessive hypertonic and acidic activity, which gives them a local irritating effect. This is why in some cases the injection of a steroid solution does not eliminate, but rather increases local inflammation and causes necrosis. Therefore, to exclude postinjection necroses and abscesses, it is proposed to include an assessment of the osmotic activity and local irritant effect of drug solutions in the drug quality control standard and to prohibit the injection of drug solutions with excessive hypertonic activity.

Drug quality drug solutions osmotic activity acidic activity irritant activity necrosis abscess

Cited by 3

Targeted temperature management, warm alkaline hydrogen peroxide solutions, and dilute solutions of local anesthetics as safety factors for circumcision

Aleksandr L. Urakov, Ilina R. Sagidullina, Petr D. Shabanov · Reviews on Clinical Pharmacology and Drug Therapy · 2025

Thermal imaging of local skin temperature as part of quality and safety assessment of injectable drugs

Aleksandr Urakov, Natalya Urakova, Aleksandr Samorodov · Heliyon · 2024

Alkaline hydrogen peroxide solutions: expectorant, pyolytic, mucolytic, haemolytic, oxygen-releasing, and decolorizing effects

Evgenii L. Fisher, Aleksandr L. Urakov, Aleksandr V. Samorodov · Reviews on Clinical Pharmacology and Drug Therapy · 2023

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