The SA Health Products Regulatory Authority (SAHPRA) has asked consumers to report any adverse events from cold and flu products containing phenylephrine as it considers an industry request for further research before deciding whether to phase it out, reports Business Day.
Phenylephrine is used in more than two dozen over-the-counter oral decongestants registered in the country.
“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 stems 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 not make any final 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.
Gopal said this was a lengthy process which had to be supported by data that SAHPRA could evaluate, and that reformulated products also require packaging changes, including new patient information inserts and labels, that must be approved by SAHPRA.
See more from MedicalBrief archives:
FDA plans decongestant ingredient removal
The decades-long struggle to get ineffective decongestant off the shelves