Caracterización de eventos adversos a medicamentos asociados al Whoart alteraciones fetales reportados al programa distrital de farmacovigilancia durante el periodo 2012 a 2017
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Montealegre Toloza, Gina Paola | 2019
The use of drugs in the gestational state is of interest in Pharmacovigilance, because of the effects derived from consumption, which are sometimes unknown. In the present study, adverse events to medications related to the WHOART Fetal Alterations, occurred and reported in the city of Bogotá, were analyzed. An analysis was made of the reports between 2012 and 2017 that were notified to the District Pharmacovigilance Program related to the WHOART fetal alterations, classifying them into Adverse Drug Reactions (RAM). The WHO algorithm was used to classify the RAM; The causality of the RAM was evaluated using the WHO algorithm. In summary, 4 abortion notifications, 2 congenital heart diseases, 1 case of polydactyly and 1 of bradycardia were presented. All serious serious reports. According to type of RAM, the majority of reports correspond to type A with 7 cases, type D a case. According to the WHO algorithm, 4 of the cases were classified as Probable, 1 cases as Unclassifiable due to the little information reported by the notifier, 2 possible case, 1 unlikely case. According to the reports analyzed for the WHOART Fetal disorders it was found that, of the 8 cases, 2 were registered by antiepileptics such as Valproic Acid and Levetiracetam. The presence of congenital heart disease in the report of the newborn is probably due to the Levetiracetam to which the mother was exposed, a probable mechanism of the teratogenic action of antiepileptics, is the production of heart rhythm disorders by direct action of drugs on the fetal heart Another case of adverse reaction in newborns occurs in childbirth when peridural anesthesia with bupivacaine is administered in a pregnant mother, developing bradycardia in the newborn. From the report in which abortion was recorded due to the consumption of the antidepressant Bupropion, the literature mentions that the use of this medication during the first trimester has been associated with fetal heart malformations in 1.3% and abortions in 15.4%. medications associated with congenital heart disease presented in the report, are Hydralazine, which has been the most commonly used treatment in severe hypertensive crisis and pre-eclampsia, with no teratogenic effects detected. Information from the present study shows that immunosuppressive therapies are associated with spontaneous abortion, such as fingolimod and natalizumab. According to a case study conducted with Fingolimod in pregnant patients, it is reported that spontaneous abortion occurs in 15% to 20% of known pregnancies, and the main birth defects occur in 4% to 8% of pregnancies. The same happens with natalizumab, which is not recommended for use during breastfeeding or pregnancy. Finally, reported abortion is reported, due to the administration of Tocilizumab in combination with Methotrexate, according to a clinical study it is confirmed that Methotrexate is a known and abortive teratogen.
LEER