Severe and unexpected events after acute withdrawal of tiapride contaminating vigabatrin: a case series

In September 2023 the Polish Ministry of Health warned that two lots of Sabril (vigabatrin) powder for oral solution and tablets, released in 2021, contained trace amounts of tiapride. We identified three children with tuberous sclerosis complex who presented in the Department of Neurology and Epileptology, Children's Memorial Health Institute with sudden clinical worsening and unexplained symptoms after withdrawal of contaminated vigabatrin lots. The reported adverse effects included increased frequency and severity of seizures, significant behavioral problems, insomnia, weight loss, and secondary amenorrhea. One patient required admission to the intensive care unit due to drug-resistant status epilepticus. Our observations suggest that rapid withdrawal of tiapride, even administered in low doses, may result in significant and life-threatening deterioration in patients with epilepsy.