THE Health Ministry has acknowledged growing public concern over the off-label use of GLP-1 receptor agonists, especially for non-medical weight loss and stressed that reporting adverse drug reactions (ADRs) is crucial to safeguard patients and strengthen oversight of these prescription medicines.
From a regulatory perspective, the Health Ministry said GLP-1 products registered in Malaysia - including semaglutide (such as Ozempic) and tirzepatide (such as Mounjaro) - are approved only for specific medical indications, dosages and conditions of use that have been thoroughly assessed for quality, safety and efficacy.
“The National Pharmaceutical Regulatory Agency (NPRA), which serves as the secretariat to the Drug Control Authority (DCA), monitors the safety of medicines in Malaysia through continuous pharmacovigilance. A key part of this system is the collection and analysis of ADR reports submitted by healthcare professionals, pharmaceutical companies and the public.
“Reports of side effects, complications or suspected misuse help regulators detect emerging safety signals, assess risks linked to inappropriate or off-label use, and determine whether regulatory action is needed,” the ministry said in response to Sinar Daily’s query.
Where concerns are identified, the DCA may issue safety alerts, update product information or impose additional controls.
The ministry emphasised that ADR reporting is not limited to doctors and pharmacists. Consumers also play a crucial role, especially as GLP-1 drugs gain wider attention for weight loss.
Timely reporting helps authorities distinguish isolated cases from wider safety trends and ensures medicines already on the market continue to be monitored effectively.
Healthcare professional can report suspected adverse reactions via the Pharmacy Hospital Information System (PhIS) for MOH facilities or submit a manual ADR report to NPRA.
Meanwhile, the public can inform a healthcare professional, who can report on their behalf, or submit a report directly through the Consumer Side Effect Reporting Form (ConSERF).
“All reports contribute to national safety surveillance and are assessed as part of ongoing pharmacovigilance efforts,” the ministry said.
It also stressed that the safe and responsible use of medicines is a shared responsibility.
“Patients are urged to seek treatment only from qualified healthcare professionals, adhere to approved medical indications and report any unexpected side effects promptly — helping safeguard public health as new and existing medicines continue to be used more widely,” it added.