BfArM Maintains Position on Tramadol Regulation

The Federal Institute for Drugs and Medical Devices (BfArM) has reaffirmed its stance regarding the regulation of Tramadol, stating that there is currently no necessity for further regulatory measures. This decision follows discussions surrounding the drug's potential for dependency and misuse, particularly among young individuals.

Recent reports indicate that Tramadol may serve as a gateway to opioid addiction. An article in 'Der Spiegel' highlighted concerns about the expert committee for controlled substances (BtM), which in a 2011 session, opted not to classify Tramadol under the narcotics control regulations. It was suggested that external influences, particularly from its original manufacturer, Grünenthal, may have played a role in downplaying the substance's risks.

In light of these concerns, BfArM has made available the protocols from the 2011 meeting and clarified that the agency does not unilaterally decide the scheduling of substances under narcotics law. Instead, it relies on recommendations from external experts, which are then considered by the government. At that time, the government accepted the committee's advice to keep Tramadol unscheduled.

BfArM emphasized that the decision was based on a comprehensive review by a specialized working group that evaluated all available information regarding the drug's dependency and misuse potential. The agency pointed to a scientific publication from this group that supported its findings.

In the years since the 2011 recommendation, BfArM has noted that no new evidence has emerged to warrant a change in regulation. The agency references a routine safety assessment conducted by the European Medicines Agency (EMA) that resulted in strengthened warnings regarding the risks of dependency and misuse in Tramadol's product information in 2024.

The updated guidelines explicitly address the low, yet present, risk of misuse and dependency associated with Tramadol. BfArM considers the current warnings sufficient to inform healthcare professionals and patients about the potential dangers. These warnings are designed to enhance awareness among doctors when prescribing the medication, pharmacists when dispensing it, and patients during its use.

As part of the update, the EMA conducted a periodic safety review of Tramadol in February 2024, prompting a revision of the warning labels by summer 2024. The product information now includes statements highlighting the risks of developing tolerance, physical and psychological dependence, and opioid use disorder with repeated use of opioids like Tramadol. It also emphasizes the importance of developing a treatment strategy collaboratively with patients, which includes establishing treatment goals and plans for discontinuation.

This careful approach aims to minimize risks associated with Tramadol while ensuring that patients receive appropriate pain management.