The President of the Office for Registration of Medicinal Products issued an important announcement regarding a drug called Sabril. The office received two reports of serious side effects among patients who used the drug.
Two batches of Sabril were withdrawn from the market in July – this was announced by the Chief Pharmaceutical Inspector in his announcement. The reason is the finding of trace amounts of tiapride (antipsychotic substance) in some batches of the drug. Even though the demonstrated content of tiapride did not exceed the permitted daily exposure, batches of the drug were withdrawn. The case continues because now the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) has received a report of two serious side effects caused by Sabril. However, the Office does not provide details about these notifications.
Sabril withdrawal – information for doctors and patients
Grzegorz Cessak, president of URPL, provided in a special announcement important information for “professional health care workers and patients in order to take appropriate actions.” As we read in the announcement, “the possibility of serious and life-threatening side effects should be borne in mind when replacing a contaminated Sabril product with a product from an uncontaminated series, especially when a product from a contaminated series has been used for a long time. Patients should remember not to discontinue treatment with Sabril from a contaminated batch without first consulting their doctor.“.
At the same time, President Cessak appeals to report any possible side effects caused by Sabril. This can be done via the form on the URPL website.
Sabril – these batches of the drug have been withdrawn
Sabril is used, among others, in combination therapy in people with partial (focal) epileptic seizures that are resistant to treatment. It is also used as monotherapy in infants with epileptic seizures. Two specific batches of the drug have been withdrawn from the market:
Sabril (Vigabatrinum), coated tablets, 500 mg, package contents: 100 tablets in blisters, GTIN number: 05909990312818, batch number: 2987B, expiration date: April 30, 2025.
Sabril (Vigabatrinum), granules for oral solution, 500 mg, package content: 50 sachets, GTIN number: 05909990832712, batch number: 1993A, expiration date: May 31, 2024.
The drugs were withdrawn by the GIF decision of July 31, 2023.