Sahpra urges public to report side effects from flu medicines

South Africa’s medicines regulator has urged consumers to report any adverse events caused by cold and flu products containing phenylephrine as it considers an industry request for further research before deciding whether to phase it out.

Phenylephrine is used in more than two dozen over-the-counter oral cold and flu medicines registered by the South African Health Products Regulatory Authority (Sahpra), including:

• Adcock Ingram’s Corenza-C;
• Aspen Pharmacare’s Flutex; and
• iNova Pharmaceuticals’ Demezin.

“This call is specifically for phenylephrine [for] anything untoward or negative that could be directly caused by the treatment,” said Sahpra’s chief regulatory officer Tammy Gopal.

The request for patients to report adverse events is part of Sahpra’s efforts to gather more data on the products, she said.

Sahpra’s concerns stem from a US Food and Drug Administration (FDA) announcement in late 2024 that it was considering phasing out phenylephrine in oral cold and flu products after an expert advisory committee concluded it was ineffective as a nasal decongestant. The FDA advisory committee did not consider phenylephrine nasal sprays or eye drops, and did not flag any safety concerns.

The Pharmaceutical Task Group, an umbrella body for pharmaceutical manufacturing associations, has pressed Sahpra to hold off on making a decision until the industry has conducted an efficacy study on phenylephrine in oral combination cold and flu products.

Phasing out an ingredient in a registered medicine has cost implications for pharmaceutical manufacturers as the reformulated product requires extensive testing and approval by Sahpra before it can be marketed. “f is a lengthy process that needs to be supported by data that Saphra can evaluate,” said Gopal.

Reformulated products also require packaging changes, including new patient information inserts and labels, that must be approved by Sahpra, she said.

Business Day