SAHPRA has clarified last week’s notification on phenylephrine contained in oral cold and flu treatments in which it asked for consumer input, saying its call for patients to report side effects was intended more broadly and not aimed solely at these products, reports Business Day.
“Phenylephrine-containing products in cold and flu medicine used as oral tablets or syrups are not cause for concern for quality and safety,” said chief regulator officer Tammy Gopal, adding that SAHPRA’s concern at this point related to the efficacy of phenylephrine in these products.
Its scrutiny of the compound comes in the wake of a 2024 proposal from the US Food and Drug Administration to phase out phenylephrine in combination decongestants concerns it didn’t work.
An FDA expert advisory committee said 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 these remedies, and raised the prospect of phasing it out.
More than two dozen such products have been registered by SAPHRA, according to its database of registered medicines.
See more from MedicalBrief archives:
SAHPRA calls for public input on flu medicines
The decades-long struggle to get ineffective decongestant off the shelves