South Africa’s medicines regulator has moved to clarify its stance on phenylephrine contained in oral cold and flu treatments, saying its call earlier this week for patients to report side effects was intended more broadly and not aimed solely at these products.
“Phenylephrine-containing products in cold and flu medicine used as oral tablets or syrups do not cause a concern for quality and safety,” the SA Health Products Regulatory Authority’s (Sahpra) chief regulator officer, Tammy Gopal, said on Friday.
Sahpra’s concern at this point related to the efficacy of phenylephrine in cold and flu products, she said.
Its scrutiny of the compound follows a proposal from the US Food and Drug Administration in late 2024 to phase out phenylephrine in combination oral cold and flu medicines over concerns it didn’t work. An FDA expert advisory committee concluded phenylephrine was an ineffective decongestant when used in oral combination products. It did not consider its use in nasal sprays or eye drops.
Sahpra has asked pharmaceutical manufacturers to provide efficacy data on phenylephrine in oral-combination cold and flu remedies and raised the prospect of phasing it out of oral-combined cold and flu remedies. Phasing the ingredient out has cost implications for manufacturers, as it would require reformulating products, providing stability data to the regulator, and making new patient information leaflets and labels for packaging.
More than two dozen such products have been registered by Sahpra, according to its database of registered medicines.
Sahpra held a meeting with industry associations for pharmaceutical manufacturers and pharmacists last week, at which drug companies asked for time to conduct clinical trials to generate new efficacy data. Gopal said Sahpra was considering the input it had received and would communicate the next steps later this month.
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