South Africa recalls weight-loss drugs including Ozempic

Written by Ziad Abdel Fattah:

The regulatory authority announced Products South African health authorities have begun recalling a number of weight-loss drugs produced by a local pharmaceutical company, following a temporary court order prohibiting the manufacture and sale of products containing “semaglutide.” This comes amid warnings from regulatory bodies regarding potential risks to patient safety.

South Africa's health regulatory authority said on Thursday that the products being recalled are manufactured by iDexis and include preparations containing semaglutide and tirzepatide, as well as combinations of the two substances, emphasizing that continuing to prescribe, dispense, or stock these products may subject healthcare professionals to disciplinary action.

Prevent iDexis from manufacturing drugs containing semaglutide

The decision comes following a temporary order issued by the Supreme Court last month, which prohibited iDexis from manufacturing or selling drugs containing semaglutide, as part of a lawsuit filed by the Danish company Novo Nordisk.

Novo Nordisk accused the local company of manufacturing and selling products containing semaglutide without registration, in violation of drug regulations, and of capitalizing on the rapid growth of the weight-loss drug market in South Africa without adhering to regulatory requirements.

Regulatory bodies, in a joint statement that included the South African Pharmacy Council, the Health Professions Council, and the South African Health Products Regulatory Authority (SAHPRA), clarified that the products included in the recall involve semaglutide and tirzepatide formulations prepared by iDexis.

Semaglutide is the main ingredient in Novo Nordisk's Ozempic and Wegovy, while tirzepatide is an ingredient in Eli Lilly's Mounjaro and Zepbound.

Regulatory authorities confirmed that the use, description, or dispensing of iDexis products after the recall decision constitutes a “serious risk to the safety of patients and users,” warning that measures will be taken against any healthcare professional found to be dealing with these products.

Vincent Tlala, CEO of the South African Pharmacy Council, told Reuters that regulators have stepped up their actions due to iDexis's failure to carry out the recall according to the required procedures, explaining that violating pharmacists could face fines ranging from 25,000 to 75,000 rand.

He added that the investigations could lead to stricter measures, including striking some practitioners' names from the professional registry, if it is proven that members of the public were harmed as a result of using these medications.

Novo Nordisk confirmed following the court ruling that the case highlights the risks associated with compounded and unregulated versions of GLP-1 drugs, a drug class that has seen widespread global use in treating diabetes and weight loss.

Tellala pointed out that the South African Pharmacy Council is working with the Department of Health to take steps which may include revoking iDexis's license, as well as coordinating with law enforcement agencies to prosecute any violations related to drug regulatory rules.

iDexis did not immediately comment on the withdrawal decision or the accusations against it.