GIF Recalls Important Drug. A Real Threat to Patients' Health

• The reason is that the content of the active substance in one of the batches is too low.
• Reduced fingolimod content could affect the effectiveness of the therapy as well as patient safety.

The Chief Pharmaceutical Inspector (GIF) has withdrawn and banned the marketing of a batch of a drug used to treat multiple sclerosis (MS). This concerns Fingolimod Stada (fingolimodi hydrochloridum):

• with serial number: 5B0350J,
• in a dose of 0.5 mg (hard capsules, pack of 28),
• expiry date: 10.2026.

The decision was made immediately enforceable, which means that the indicated series must be immediately withdrawn from sale and further trade in it is prohibited.

The Chief Pharmaceutical Inspectorate (GIF) has received information about a deviation from the specifications for Fingolimod Stada 0.5 mg for batch number 4D9181. The deviations were detected in samples collected after 12 months of storage. Although this batch was not distributed to the Polish market, the notifying party indicated that with respect to batch no. 5B0350J delivered to Poland, although it was not subject to testing, due to the detection of deviations, a decision was made to block this batch as well.

The drug manufacturer subsequently confirmed that the identified anomaly concerned only the reduced fingolimod content. Other quality parameters were satisfactory. It was also noted that batch 4D9181 was representative of all production from the same year, including batch 5B0350J.

The root cause of the discrepancy has been initially determined, according to GIF, but the investigation is still ongoing.

The inspector also explained in his decision that the drug's stability and compliance with quality standards are important for its effectiveness and safety. Therefore , he "determined a real risk to patients' health resulting from the lack of the assumed efficacy of the analyzed medicinal product."

Fingolimod Stada is used, as a reminder, to treat relapsing-remitting multiple sclerosis in adults and children over 10 years of age with a body weight of over 40 kg.

The drug's active ingredient, fingolimod, reduces the number of relapses and slows the progression of disability in patients. It therefore helps control MS symptoms.

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