Background: Pregabalin (PGB) has been an anti-epileptic and an effective treatment of neuropathic pain; it acts by inhibiting certain presynaptic calcium channels and decreased excitatory neurotransmitters. There are reported serious effects following PGB exposure beside its addictive effect. Aim of the work: Study the pattern of acute PGB toxicity in patients admitted to Poison Control Center-Ain Shams University Hospitals (PCCASUH) and its histopathological effects after acute toxic dose in adult albino rat brain. Methods: The study was comprised of two parts. The clinical part: on 31 patients admitted to PCCASUH with a history of acute PGB toxicity. The experimental part: on thirty adult albino rats, divided into two groups (acute toxicity group received acute single dose of PGB5000 mg/kg and the control group received normal saline). Results: Acute PGB exposure leads to mild toxicity and most of symptoms related to CNS included DCL, with a significant relation between the prolonged period of hospital admission and the DCL. The experimental results revealed that the cerebral cortex (CC) and cerebellum showed degeneration of nerve cells, pyknosis with karyolysis of nuclei, and a marked increase in the glial cells with positive glial fibrillary acidic protein (GFAP) cytoplasmic granules in the CC (toxic group). Conclusion: The course of PGB intoxication is mostly mild self-limiting and most of patients discharged on the next day of admission. The experimental study concluded that PGB has degenerative effects on brain nerve cells. Recommendations: further studies with larger sample size to evaluate the acute and chronic toxicity of PGB.
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