Another drug for serious diseases withdrawn from sale. GIF warns

We recently reported that the anticancer drug Vblaast 10 Vinblastine Sulfate was withdrawn from sale. Today, February 12, 2024, the Chief Pharmaceutical Inspector issued a notice removing another drug for oncology patients from the market in the Republic of Poland. This time it is about Misintu (Mitomycinum), a medicinal product used in the treatment of patients with: stomach cancer, breast cancer, lung cancer, bladder cancer, cervical cancer, head and neck cancer and other types of cancer.

Misintu – GIF decision details

In a published statement, the Chief Pharmaceutical Inspector (GIF) provided details about the withdrawn drug. Two product series have been removed from the market:

Misintu, (Mitomycinum), solution for injection and infusion, 20 mg x 1 vial

• series number 30313010, expiration date: March 6, 2025

• series number 30845510, expiration date: August 11, 2025

• responsible entity: Koçsel İlaç San. ve Tic. A.Ş. based in Turkey,

• entity that has obtained consent to temporarily admit the above-mentioned products to trading. medicinal product: Genesis Pharm sp. z o. o. sp. komandytowa, ul. Obywatelska 128/152, 94-104 Łódź.

GIF decided not only to remove the mentioned batches of the anticancer drug from sale. He also banned their introduction into the country. The decisions were made immediately enforceable.

Why did GIF withdraw the anticancer drug from pharmacies?

The Chief Pharmaceutical Inspector received a report about the detection of a quality defect in the indicated batches of Misintu. After dissolving the preparation in water and preparing it for injection, insoluble particles of unknown origin appeared in the solution, visible to the naked eye. “In the case in question, during the preparation of the medicine, the medical staff was unable to prepare a solution that would meet the requirements contained in the information attached to the packaging. Particles visible to the naked eye remained in the solution, sedimenting (falling – editor’s note) to the bottom of the syringe (…). It should be emphasized (…) that the occurrence of such a quality irregularity creates a real danger resulting from the risk of such particles entering the patient’s bloodstream, which may lead to unpredictable, negative health effects,” we read in the GIF press release.