South Africa’s medicines regulator is facing strong pushback from pharmaceutical manufacturers over its proposal to phase out phenylephrine in oral cold and flu remedies due to concerns the popular ingredient doesn’t work.
Phenylephrine is found in more than two dozen cold and flu products registered by the South African Health Products Regulatory Authority (Sahpra), including well-established brands such as Adcock Ingram’s Corenza-C, Aspen Pharmacare’s Flutex and iNova Pharmaceutals’ Demazin. These are all over-the-counter drugs that do not require a prescription.
The medicines have been on the market for decades and were never subjected to the rigorous evaluation that faced products launched after the implementation of the Medicines and Related Substances Act in 1966.
Sahpra has asked local companies for evidence that phenylephrine-containing oral decongestants work after an advisory committee to the US Food and Drug Administration (FDA) unanimously concluded the products are ineffective. The review focused on the use of oral phenylephrine as a decongestant and did not consider phenylephrine nasal sprays or eye drops.
“Our mandate is safety, quality and efficacy. We cannot have a product on the market that may not be effective because, in essence, you’re giving the public a placebo,” said Sahpra CEO Boitumelo Semete-Makokotlela.
Asking the public to pay for a placebo was not ethical, she said.
Sahrpra first flighted the possibility of phasing out phenylephrine in oral decongestants a year ago, and asked pharmaceutical companies to submit evidence the ingredient was effective. The regulator has yet to receive any data and has scheduled a meeting for April 24 to discuss the potential implications of a phase-out and the scope to conduct further studies, said Semete-Makokotlela.
Among the issues flagged by the FDA advisory panel was the very low bioavailability of oral phenylephrine, which means a very small proportion of it reached the bloodstream and could potentially have an effect.
Sahpra has not flagged any safety issues with phenylephrine or expressed concern about the efficacy of nasal sprays or eye drops containing the ingredient.
The FDA proposed in November 2024 that oral phenylephrine be removed as an active ingredient in over-the-counter drugs used for the temporary relief of nasal congestion. At the time, the American Pharmacists’ Association expressed support, saying its members reported patients often complained that oral phenylephrine products did not provide relief from nasal congestion. The FDA has yet to take a final decision on the matter.
South Africa’s umbrella organisation for drug manufacturer associations, the Pharmaceutical Task Group (PTG), said it opposed phasing out oral phenyleprhine. The evidence scrutinised by the FDA’s advisory committee review was flawed because it considered only single-ingredient phenylephrine products, and not the combinations typically used in cold and flu preparations, said PTG chairperson Stavros Nicolaou.
Combination products could plausibly be more effective than phenylephrine taken alone due to the synergistic interplay between the components, said Nicolaou. For example, paracetamol had been shown to increase the bioavailability of phenylephrine, he said.
Pain and fever relievers such as paracetamol and aspirin, along with other ingredients such as anthistamines and caffeine, are used in many of the oral phenyelephrine-containing cold and flu products sold in South Africa.
The PTG was concerned about the lack of suitable alternatives for patients who could not safely take the decongestant pseudoephedrine, which is contraindicated for individuals with high blood pressure, he said.
“Restricting these products limits patients’ options, and will potentially reduce access to treatment and increase costs,” he said, suggesting it could lead to an increase in consultations with doctors and an uptick in inappropriate prescriptions for antibiotics.
Adcock Ingram acting CEO Dorette Neethling said the company was engaging constructively with the regulator as it did not support a blanket or immediate withdrawal of phenylephrine-containing fixed-dose combination products.
“The international findings relate to mono-ingredient phenylephrine and do not directly apply to South Africa’s combination cold and flu products, which remain important for public health access,” she said.
The Independent Community Pharmacy Association (ICPA), which represents independent pharmacy businesses, said it supported scientific evidence-based intervention by the regulator.
“There are very few products available in South Africa for people wanting to treat colds and flu. Our call to Sahpra is to take a conservative view, to allow industry time to bring forward studies on these multi-ingredient dosage forms,” said ICPA CEO Jackie Maimin.
The Pharmaceutical Society of South Africa (PSSA), which represents the pharmacy profession, said it was important any changes to the status of oral phenylephrine-containing decongestants were clearly communicated to pharmcists and the public.
If the regulator decided to withdraw the products, it was important to do it in a gradual manner to allow time for the stock to be phased out, said PSSA executive director Refiloe Mogale.
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.