ANVISA warns of risks of indiscriminate use of paracetamol after Covid-19 vaccination

RIO DE JANEIRO, BRAZIL – The indiscriminate use of paracetamol for pain and fever relief after Covid-19 vaccination can lead to serious adverse events, including drug hepatitis and death, Brazil’s health regulatory agcency ANVISA has indicated.

According to the agency, paracetamol should be used with caution, “always observing the maximum daily dose and the interval between doses, according to the recommendations contained in the package insert, for each age group.”

ANVISA’s division monitoring health products subject to surveillance recommends health professionals and the general population to notify the agency about cases of adverse reactions after the use of the drug.

The main reactions observed after Covid-19 vaccination are fever, headache, and body aches, which vary from mild to moderate. But it is important to note that these effects should disappear within a few days.

Notification

The occurrence of any adverse effects after the use of paracetamol and other drugs should be immediately recorded through VigiMed, ANVISA’s system for reporting adverse events, both by citizens and health services.

Suspected quality defects (technical complaints) regarding drugs in health institutions should be registered through Notivisa.

ANVISA advises that it is of utmost importance that the notification contains a set of information, such as detailed identification of the suspected drug, manufacturer data, concentration and batch, as well as dose and time of use.

Caution in correct use

According to the General Monitoring division, paracetamol has been used to relieve symptoms of post-vaccine adverse effects, such as fever and headaches. However, incorrect use may cause serious adverse effects, including with fatal outcome, when use is prolonged or above the maximum daily dose.

Users should keep in mind that for any medication there is a risk associated with its consumption. Therefore, it is essential that the product be used correctly, following the recommendations in the package insert and health professional’s guidelines.

Recommendations

Below is information about the maximum daily dose of paracetamol for each age group, according to the package insert:

Adults and children over 12 years of age: maximum dose is 4 grams per day.

Children between 2 and 11 years old: no more than 50-75 mg/kg in one day (24 hours) should be used.

For children under 11 kg or 2 years old or under 20 kg: consult a physician before use.