Subscribe
Share
Share
Embed
Covering Patient Safety, Drug Safety, Pharmacovigilance, Osteonecrosis of the Jaw, Pharmaceutical. This episode covers critical regulatory developments in patient safety, pharmacovigilance, and pharmaceutical oversight, including updated educational materials for Atrasentan, Denosumab, and Adalimumab, plus voluntary recalls impacting multiple drug batches.
Regulatory news, updates, and insights for countries in the Middle East presented by the Carver Agents team
Welcome to Carver's Middle East Regulatory Updates for September 05, 2026.
The Saudi Food and Drug Authority, or SFDA, has approved updated educational materials version 1.1 for the drug Atrasentan. These materials include safety cards and patient risk management information to inform healthcare providers and patients about the teratogenic risks associated with Atrasentan. The SFDA requires that these approved educational materials be distributed to patients prescribed Atrasentan. Patients must be advised to use contraception during treatment and for two weeks after stopping the medication. Additionally, pregnancy testing is mandatory before starting treatment, and the drug must be discontinued immediately if pregnancy occurs.
In related pharmaceutical safety news, the SFDA has approved and published patient educational materials and safety reminders for Denosumab Wyost. These highlight the risks of osteonecrosis of the jaw, or ONJ, and recommend precautions before and during treatment. Healthcare professionals are required to inform patients about ONJ risks and conduct dental assessments when indicated. Patients should maintain good oral hygiene and promptly report any oral symptoms. All adverse events must be reported to both the Saudi Food and Drug Authority and the Sandoz Patient Safety Department.
The SFDA also introduced a patient alert card for Adalimumab, detailing risks of serious infections, malignancies, demyelinating disorders, and vaccination guidance for patients and healthcare providers. Healthcare providers must inform patients about these serious risks before and during treatment. Patients must be monitored regularly and report symptoms immediately. Live vaccines should be avoided during treatment and for five months after the last injection in pregnancy.
The Saudi Capital Market Authority published a list of key inquiries and their answers regarding license applications for commodities and metals market activities in Saudi Arabia. This publication aims to assist interested parties by enhancing transparency and understanding of licensing requirements. Applicants are advised to refer to the Capital Market Law and its executive regulations for comprehensive licensing details. License applications for these activities have been accepted starting from July 1, 2026.
The Saudi Food and Drug Authority has issued multiple voluntary recalls affecting several pharmaceutical products to ensure patient safety and maintain product quality. Healthcare practitioners in Saudi Arabia must immediately stop dispensing and quarantine affected batches, returning them to suppliers according to established procedures. Patients are advised to consult healthcare providers before stopping any medication.
The recalled products include:
- Credanil 100/25mg tablets, specific batches subject to recall.
- Credanil 100/10mg tablets, specific batches subject to recall.
- Bralix 5/2.5mg tablets, specific batches subject to recall.
- Lorivan 2mg tablets, recalled due to out-of-specification results affecting quality and safety.
- Clonotril 0.5mg tablets, batches 114646 and 120094 manufactured by REMEDICA LTD in Cyprus.
Healthcare practitioners must inform patients about the recalls and advise them to consult before discontinuing medication. Patients should also report any adverse effects via the SFDA’s electronic vigilance system.
That wraps up today's regulatory updates. Visit carveragents.ai for more information.