Health alert in Spain for withdrawal of a batch of popular brain tumour drug

A health alert was issued in Spain for the withdrawal from circulation of a batch of the popular brain tumour drug, Temozolomide SUN.

The alert was for a drug that is used treat certain types of brain tumours and was issued by AEMPS, the Spanish Agency for Medicines and Health Products. It was also reported in a statement from FACUA on its official X account this Wednesday, November 8.

Retiran un lote del medicamento contra tumores cerebrales Temozolomida SUN por un defecto de calidad. https://t.co/bTk8DTxglA pic.twitter.com/qojofe35CS

— FACUA (@FACUA) November 8, 2023

What is the product batch number?

The affected batch in question is HAD3165D, with an expiration date of July 31, 2024. It is marketed in the format of 5 5 mg EFG hard capsules, and is being withdrawn due to a suspected quality defect.

As explained in the statement, Temozolomide SUN contains a medicine called temozolomide, which is an anti-tumour agent.

It is prescribed to treat adults with newly diagnosed glioblastoma multiforme. Initially, it is used in combination with radiotherapy (concomitant phase of treatment) and then alone (monotherapy phase of treatment).

What is Temozolomide SUN used to treat?

Temozolomide SUN is also used to treat children 3 years and older and adults with malignant glioma. These include glioblastoma multiforme or anaplastic astrocytoma. The drug helps to combat these tumours if they come back or worsen after standard treatment.

Among the precautionary measures, the AEMPS reported that all distributed units of the affected batch have been withdrawn from the market and returned to the laboratory through the usual channels.

In any case, the health agency reported that this quality defect does not pose a vital risk to patients, classifying the defect as Class 2.

Quality defects in medicinal products are classified into three classes (1, 2 and 3), with class 1 corresponding to a possible higher risk and class 3 corresponding to a lower risk.