The Polish healthcare system is facing a significant challenge as the Main Pharmaceutical Inspectorate (GIF) has announced the immediate withdrawal of the popular bladder infection medication, Furaginum MAX, from pharmacies across the country. This decision, made public on April 9, 2025, comes after the detection of serious quality issues that could pose a risk to patient health.
Furaginum MAX, produced by US Pharmacia sp. z o.o., is primarily used to treat urinary tract infections, particularly bladder inflammation. However, the GIF's statement revealed that the drug does not meet the required quality standards due to a negative test result for the presence of nitrosamines, specifically NDMA (N-nitrosodimethylamine), a chemical compound known for its potential carcinogenic effects.
In a statement released on platform X, the GIF emphasized, "For the protection of health and life of patients who could take a medicinal product that does not meet quality requirements, it was justified and necessary to give this decision the force of immediate enforceability." This highlights the urgency of the situation and the potential dangers posed by the continued use of Furaginum MAX.
The withdrawal affects all series of Furaginum MAX with the identifier GTIN 05903031289442, packaged in 30-tablet containers. Patients are advised to cease using the medication immediately and can return any remaining stock to their pharmacies for disposal.
This incident is not isolated. Just weeks earlier, in mid-March 2025, the GIF also suspended the sale of another widely used medication, Veriflo, an asthma treatment. This decision was based on findings from the National Medicines Institute, which revealed that Veriflo failed to comply with critical quality parameters outlined in its registration documentation. The GIF noted that any deviations from these standards could pose a real and direct threat to the health or life of patients until the cause of the discrepancy is clearly identified and proven not to pose such a threat.
The GIF's actions underscore the importance of stringent quality control in the pharmaceutical industry. Despite being produced by reputable companies, medications can sometimes fail to meet the rigorous standards necessary for consumer safety. The presence of carcinogenic substances, like NDMA, in medications is particularly concerning, as long-term exposure can increase the risk of developing cancers of the liver, stomach, and intestines, as well as causing milder health issues such as inflammation or liver cirrhosis and impaired kidney function.
In light of these developments, the GIF has urged patients who possess Furaginum MAX to dispose of it safely and has reiterated its commitment to monitoring the quality of medicinal products. The GIF’s responsibilities include overseeing the conditions under which drugs are transported, stored, and advertised, ensuring that all medications available to the public are safe and effective.
The decision to withdraw Furaginum MAX is part of a broader effort by the GIF to maintain high standards in the Polish pharmaceutical market. The agency has been proactive in identifying and addressing potential threats to public health, as evidenced by its recent actions against both Furaginum MAX and Veriflo.
As the GIF continues to monitor the situation, it remains critical for consumers to stay informed about the medications they are using. The presence of NDMA in medications is a reminder of the potential hazards that can arise from improper manufacturing processes. Patients are encouraged to consult their healthcare providers for alternative treatments if they have been using Furaginum MAX or any other medications that have been recently withdrawn from the market.
In conclusion, the withdrawal of Furaginum MAX serves as a vital reminder of the importance of pharmaceutical oversight and the need for ongoing vigilance in ensuring the safety of medications. Patients must remain aware of the products they use and should report any concerns to their healthcare providers or the appropriate regulatory authorities.
