V-Tech’s dispute with SAHPRA continues: Updates on Yohimbine and Trilostane Shortages.
Recent developments have presented significant challenges to the South African veterinary community due to regulatory issues surrounding two critical medications: Yohimbine and Trilostane.
Earlier this year, Yohimbine, an essential antidote for reversing the effects of sedatives used by wildlife veterinarians, was seized and destroyed by Port Health. This drastic action, taken at the direction of the South African Health Products Regulatory Authority (SAHPRA), has left wildlife practitioners without a vital resource for safely managing animal sedation during wildlife translocation projects.
V-Tech found itself in a challenging situation when its shipment of Yohimbine was detained by Port Health. Despite engaging in discussions with SAHPRA regarding the validity of the detention, the shipment was ultimately destroyed under claims that it was a banned substance. This move left both V-Tech and the wider veterinary community disheartened.
Dr Johan Oosthuyse, CEO of V-Tech, expressed his frustration over how the situation has been handled. He underscored the critical role Yohimbine plays in ensuring the safety and well-being of wildlife during immobilisation procedures. “For the past six years, we have relied on Yohimbine to create a vital antidote necessary for reversing the effects of tranquilisers used in capturing wild animals and the symptoms of Amitraz poisoning,” Dr Oosthuyse stated. “The lack of access to Yohimbine not only endangers valuable wildlife but also undermines the ability to conduct essential veterinary procedures safely. It is disheartening to witness a lack of appreciation for veterinarians’ critical need for access to medications, particularly those not commonly used in human medicine.”
Since this incident, V-Tech and SAVA have taken the lead in advocating on behalf of the veterinary community. In response to V-Tech’s efforts, SAHPRA issued a public call on October 6, 2024, for scientific studies and stakeholder input to reassess the safety, efficacy, and therapeutic potential of Yohimbine in veterinary practice. This signals a shift in SAHPRA’s position on Yohimbine, offering a potential pathway to restoring access to the substance.
However, V-Tech maintains that Yohimbine was never banned for veterinary use, as there is no evidence that the substance was ever formally gazetted for such a ban. V-Tech cautions that SAHPRA’s consultation process could be lengthy and calls for the immediate reinstatement of Yohimbine for veterinary use to avoid further disruptions to wildlife conservation.
Dr Oosthuyse also noted that this isn’t the first time Port Health and SAHPRA’s actions have obstructed veterinarians’ ability to treat animals effectively. In October 2023, V-Tech was compelled to seek legal action when another crucial medication, Trilostane – which is unscheduled – was confiscated by Port Health but later released.
The Trilostane dispute escalated to the courts, where a judge instructed SAHPRA and V-Tech to reach an agreement on the release of an initial batch. Following this directive, V-Tech collaborated closely with SAHPRA to secure the necessary arrangements, allowing veterinarians to provide essential treatment to pets. However, the situation has taken a turn for the worse, as SAHPRA is now
blocking the use of additional batches despite V-Tech’s compliance.