The Pharmacy and Poisons Board (PPB) has cautioned Kenyans against the unsupervised or off-label use of semaglutide-containing medicines, commonly marketed under brand names such as Ozempic, saying the injections are prescription-only and may cause serious harm when used without medical oversight.

The regulator issued the safety alert on August 19, 2025 as demand for the drug for weight loss has grown.

The PPB reminded the public that semaglutide is approved in Kenya for the treatment of adults with type 2 diabetes mellitus whose condition is insufficiently controlled by other measures, and not for general weight management.

2025-08-19T12:52:25+00:00

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Internationally, a higher-dose formulation of semaglutide has been approved for chronic weight management under the brand name Wegovy by the US Food and Drug Administration, but that licence and dosing differ from Ozempic’s authorisation for diabetes.

In its statement the board listed several adverse outcomes linked to inappropriate use.

Hypoglycaemia (low blood sugar).

Eye conditions.

Gastro-oesophageal reflux (acid).

Intestinal obstruction.

The PPB said that while semaglutide can have clinical benefits when prescribed and monitored, its off-label use may result in serious health outcomes.

Members of the public are urged not to self-prescribe or obtain injections from unregulated sources.

The regulator also warned about the circulation of falsified or substandard semaglutide products.

The PPB has previously issued alerts about counterfeit Ozempic pens in the market and advised consumers to report suspect products.

The World Health Organization has likewise issued global alerts after detecting falsified semaglutide batches in several countries.

Those factors, the board said, increase the risk that users purchasing injections privately may receive ineffective or harmful preparations.

Kenya’s medicines regulator provided channels for reporting adverse effects and suspect products, including its pharmacovigilance portal, an email address and a helpline.

The PPB asked anyone who experiences side effects or who has information about potentially poor-quality or illicitly supplied semaglutide products to submit reports through the following official reporting channels of the Pharmacy and Poisons Board (PPB);

Pharmacovigilance Electronic Reporting System pv.pharmacyboardkenya.org

Email: pv@ppb.go.ke

Phone No: +254 795 743 049

USSD Code (For the Public): *271#

The PPB’s alert comes amid broader international regulatory activity.

Regulators such as the US Food and Drug Administration have warned against unapproved or illegally marketed GLP-1 products and urged consumers to avoid purchasing medicines sold outside authorised supply chains.

The Kenyan board said such global concerns reinforce the need for prescriptions and clinician supervision when using semaglutide-class medicines.

Health professionals and pharmacy operators in Kenya are bound by national law to dispense prescription medicines only against a valid prescription.

The PPB’s advisory reiterates that obligation and stresses that decisions about use, dosing and follow-up should be made by qualified clinicians to reduce avoidable harm.