Reacciones adversas com Misoprostol reportadas al Programa Mundial de Farmacovigilancia de la OMS 1985-2019
Ferro Holguín, Laura Natalia | 2020
Misoprostol is a synthetic analogue of prostaglandin E1, which has several therapeutic indications (1), in some countries it is used as an antiulcer to prevent gastric ulcers induced by non-steroidal anti-inflammatory drugs, but the main indication and in which emphasis is on gyneco-obstetrics since its uterotonic activity makes it effective as a labor inducer and as an abortive agent, being used mainly in the first trimester of pregnancy, administered orally, vaginally, sublingually, orally or rectally (2).
The use of misoprostol as a labor inducer has been increasing in recent years although it is not yet authorized by several important regulatory entities such as the FDA (Food and Drug Administration) and other international pharmaceutical regulatory agencies including the Royal British College of Obstetricians and Gynecologists, this because the available evidence suggests possible serious risks, such as uterine rupture, maternal mortality, perinatal mortality and sepsis in addition to the lack of data on the serious risks of induction with this drug.
This increase is due to the easy access of this medicine and its poor regulation, since it can be obtained even at home, a medical prescription is not required and there is often an overdose because it is believed that the higher the concentration, the more effective in the treatment; studies have shown that an 800mcg monotherapy of intravaginal misoprostol is effective in most cases as long as the patient is less than 63 days pregnant (3).
Even so, the induction with misoprostol by several health entities as a family is still being promoted and deliberately recommended, leaving aside the number of existing cases with serious adverse effects in women between 19-30 years.
Care should be taken with the use of misoprostol as a labor inducer since it can have many health conditions such as diarrhea, incomplete interuption of pregnancy, allergies, among others, it is necessary to meet certain requirements for the treatment to be successful in addition to obtaining a good medical diagnosis to determine if it is allow to get the medicine.
The present research aims to characterize these adverse reactions based on the world pharmacovigilance program of WHO 1985-2019 and then propose a communication piece for all the people for the identification, prevention, treatment of the information and reporting of adverse reactions by using Misoprostol.