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

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.

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“…These complications are not caused by injection of any specific drug, and cannot be explained by the known mechanisms of drug action. Additionally, Nicolau syndrome can develop after injections of local anesthetics, steroids, nonsteroidal anti-inflammatory drugs, chemotherapeutic agents, vaccines, and a combination of drugs [ 20 , [36] , [37] , [38] , [39] ]. Tachon syndrome, similar to Nicolau syndrome, describes post-injection complications of steroid injection into an artery and vein [ [40] , [41] , [42] ].…”

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“…Our assumption is substantiated by the following recent discovery by Russian researchers. It has been shown that the local effect of various drugs from different pharmacological groups, developing in the first seconds and minutes during local interaction with tissues at the site of application, instillation or injection and causing local irritant, inflammatory and necrotic effects, is of a universal nature, not related to the specific pharmacological activity of the main ingredients [21]. Moreover, it has been shown that one of the causes of local irritant, inflammatory and necrotic effects of dosage forms (solid, liquid and gaseous) is their excessive physical-chemical aggressiveness due to excessive hypertonic and/ or hyperacidic activity by ignorance [21,22].…”

“…It has been shown that the local effect of various drugs from different pharmacological groups, developing in the first seconds and minutes during local interaction with tissues at the site of application, instillation or injection and causing local irritant, inflammatory and necrotic effects, is of a universal nature, not related to the specific pharmacological activity of the main ingredients [21]. Moreover, it has been shown that one of the causes of local irritant, inflammatory and necrotic effects of dosage forms (solid, liquid and gaseous) is their excessive physical-chemical aggressiveness due to excessive hypertonic and/ or hyperacidic activity by ignorance [21,22]. The fact is that blood and most tissues of the human body have alkaline activity within pH 7.4 and osmotic activity within 280-300 mosmol/L of water, so it is alkaline and isotonic activity that is normal for most microorganisms that are human pathogens.…”