December 2, 2022

Covid. Doubts about paracetamol and these answers that do not arrive

by A. Donzelli, V. Frajese, P. Gentilini, E. Serravalle

03 FEBDear director,
already from February 10, 2021, the Sustainable Development and Health Network had sent with PEC a document asking to critically discuss the role of paracetamol in the 1st phase of a Covid-19.

The main messages on which a comparison was requested were:
• Viral growth must be contained in the 1st phase of Covid-19. Fever is generally a useful initial defense against pathogenic germs, maintained for this reason over millions of years of evolution.

• Paracetamol reduces fever, with the risk in initial infections of promoting the multiplication of viruses and their descent into the lungs, overcoming the innate defenses of the upper respiratory tract, as described in a convincing immunological model of Covid-19. This model also seems to be accepted by AIFA, in the therapeutic map which offers, in the 1st phase of Covid-19, therapeutic responses aimed at countering viremia.

Paracetamol, in addition to inhibiting an important non-specific defense tool against infections such as fever, also consumes our antioxidant defenses.

• There are preliminary indications that acetaminophen (and systemic ibuprofen) may also to some extent increase the adverse effects of common respiratory infections and increase infectiousness.

• Without valid research demonstrating its usefulness in Covid-19, it should not be used, at least in the 1st phase.

No response was ever received from any of the institutions contacted.
On another occasion, we also reported the danger linked to the indications for doses and use contained in the circular of the Ministry of Health of April 26, 2021 relating to the home care of patients infected with SARS-CoV- 2.

Indeed, the circular, referring to home care in pediatric and developmental age, specifies “… it is recommended in case of need (fever > 38.5°C, sore throat, headache, joint pain , etc.), on the recommendation of the pediatrician/doctor, administer symptomatic treatment with paracetamol (10 – 15 mg/kg/dose every 5-6 hours)…”.

By applying the ministerial indication to the letter, ex. for a 14-year-old subject (indicative average Italian weight 53.7 kg), there are four possibilities, taking into account a dose every 6 hours (4 times a day) or every 5 hours (4.8 times a day). day)
1) 10mg x 53.7 x 4 = 2148mg per day
2) 10mg x 53.7 x 4.8 = 2.578mg “”
3) 15mg x 53.7 x 4 = 3.222mg “”
4) 15mg x 53.7 x 4.8 = 3.866mg “”.

However, if one consults the summary of product characteristics with the doses established by the AIFA, one reads that “In adults, the maximum oral dose is 3000 mg of paracetamol per day” and “if paracetamol is taken in high doses, check for serious side effects”. reactions”.

Thus in two scenarios described out of 4 the boy/girl would exceed the maximum dose for adults, exposing themselves to serious risks; this could occur in all four scenarios if it were an obese subject.

Since there is no reason to imagine that the doses specified by the circular for the pediatric age (10 – 15 mg / kg / dose every 5-6 hours) should rather be reduced in adults, in a 70 kg subject (Italian national average weight 18-65 years) exceeding 3000 mg per day may occur increasingly in three out of four scenarios, and in all scenarios even more significantly in the case of adults Overweight.

A year after we formally raised the issue with Italian healthcare institutions, it seems urgent:
1) modify the ministerial circular,
2) accept from the CTS and health establishments the urgency of the technical-scientific comparison requested so far without success by the Independent Medical-Scientific Commission (CMSi) on the different strategies to fight the pandemic,
3) open media channels for health education based on scientific evidence and independent of the influence of commercial sponsors. In fact, even in the case of paracetamol in case of fever, these may have influenced the timidity with which the professional societies expressed themselves until now, and the institutional inertia* in the face of the most consumed drug in Italy ( also sold in the branded form 3-4 times more expensive than generic paracetamol, although with identical composition and dosages).
For the Independent Medical-Scientific Commission:

Dr. Alberto Donzelli, specialist in Hygiene and Preventive Medicine and Food Sciences
Professor Vanni Frajese, university professor of endocrinology
Dr. Patrizia Gentilini, specialist in oncology and hematology
Dr. Eugenio Serravalle, pediatric specialist

February 03, 2022
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