Hamida Hamdi Mohammed Ismail

The use of the older generation antiepileptic drugs (AEDs) during pregnancy and lactation is known to be associated with increased risk of birth defects in the offspring. Much less has been known about newer generation AEDs to which Levetiracetam (LEV) belongs. LEV is a broad spectrum antiepileptic drug which is currently licensed worldwide. The aim of this study was to evaluate the teratogenic effects of LEV on fetuses of albino rats. Pregnant albino rats(Rattusnorvegicus) were administered daily oral doses of 300mg/kg or 600mg/kg from the 5th day of gestation till the end of lactation.The animals were sacrificed at the end of gestation and during lactation. Fetuses were removed from the uterus and evaluated for mortality rate, growth parameters, morphological and skeletal malformations as well as histological study of brain, liver and kidney. The data revealed that fetal weights were significantly reduced in most study groups. Resorption rates were significantly increased with increasing LEV doses. It was found that mild degenerative changes were observed in the liver, kidney as well as the brain following LEV administration. Levetiracetam pretreatment caused a non-significant effect on the level of lipid peroxidation. No significant correlation was noted between GSH levels and the anticonvulsant effects of Levetiracetam. Thus administration of LVE during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Keywords: antiepileptic drugs, teratogencity, gestation, lactation.

Although animal research ethics committees (AREC) are well established in Western countries this field is weakly developed and its concept is poorly understood in the Middle East and North Africa region. Our main objective was to establish the first animal ethics committee to introduce the concept and requirements of ethical approaches in dealing with experimental animal models in Egypt.
To achieve this we established our standard operating producers (SOP) according to international
guidelines. Our SOP constituted the AREC responsibilities, committee member
s selection, evaluationprocedures emphasizing the regional cultures, etc. T
he challenges encountered by the committee were diverse such as the absence of laws that control the
use of animal models in scientific research, lack of guidelines (protocols for animal subjects in research) and mandatory ethical approval for any experimental animal research. To ov ercome the challenges, high univer
sity authorities were approached
to approve the establishment of an AREC committee.
Moreover, workshops were instigated in different
universities to: 1) emphasize the legal requirement
of animal research ethics approval; 2) describe the guidelines how ethical evaluation of scientific proposal will be carried out; 3) facilitate interaction with best practices and research experts and 4) teach young researches how to write protocol involving the use of animal subjects in research. In three months, we were able to conduct three workshops after each workshop questionnaire and evaluation was obtained to overcome weak points.