South Africans will not be able to find some of the nation’s most popular cough syrups this winter as they have been withdrawn from the market due to safety concerns for patients who need anaesthetic. This threat persists even up to 12 months after the cough medicine had been taken.

What is pholcodine?

Pholcodine is an opioid medicine but research has shown that it is not addictive. In South Africa, cough syrups containing this ingredient can be bought over the counter. It is a popular product for the treatment of dry coughs and can also be found in some cough lozenges.

According to a report issued on the matter by the European Medicines Agency, it “works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.”

Which medicines are affected by the recall?

The medicines affected by the recall are Pholtex Forte, Pholtex Junior, Procof, Folcofen, Pholtex Plus, Adco-Pholcolint, Contra-Coff, Docsed, and Tixylix.

Why are these medicines being withdrawn?

A spokesperson for Sahpra Melanie Govindasamy said that in 2018 a South African case of an anaphylactic reaction to anaesthetics after the use of cough syrup containing pholcodine was noted on the World Health Organization’s pharmacovigilance database, VigiFlow.

“The case involved a female patient of unknown age who experienced an anaphylactic reaction from using a pholcodine preparation. The case was entered into the database in 2018,” she added.

Since December, the medicines containing pholcodine have been withdrawn from markets in Europe. It had been withdrawn from markets in Sweden in the 1980s and in Norway in 2007. It was there that researchers first probed why people in Norway were having anaphylactic reactions to anaesthetic but not in Sweden and made the link to pholcodine.

Godvindasamy said Sahpra became aware of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee’s intentions to withdraw pholcodine from European markets due to its use associated with anaphylactic reaction during anaesthesia with neuromuscular blocking agents (NMBAs) in early December 2022. 

“However, this was a preliminary decision that was still to be endorsed by its Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh). The decision by EMA to withdraw was endorsed in mid-December 2022.

“Sahpra continued to review the data available, to validate the signal. During the review, Sahpra noted that the pholcodine-containing medicines were previously withdrawn from the market in Sweden and Norway. Furthermore, Sahpra noted publications that supported the hypothesis that pholcodine use may increase the likelihood of patients having an anaphylactic reaction if they are exposed to an NMBA. Based on the available data, other regulatory authorities have consequently changed the prescription status for these medicines from over-the-counter to prescription-only.”

She said Sahpra had concluded in March 2023 that there was sufficient evidence to support the causal link between pholcodine use and anaphylactic reactions when receiving certain types of anaesthetics.

A withdrawal issue was issued as a result.

Can you still find your favourite cough syrup?

The withdrawal order will see the removal of some of South Africa’s most popular cough syrups from the shelves.

Godvindasamy said the withdrawal order meant that all medicine containing pholcodine must immediately be removed and all remaining stock should be returned to the manufacturer. 

“It is a criminal offence to continue a sale of a medicine withdrawn from the market,” she added.

What if you still have some of the medicines on the list at home?

She said if people still have opened bottles of medicine on the list they must take it to their pharmacy that will handle the disposal.

The EMA has issued guidelines to the public who need surgery to tell their anaesthetist if they had taken medicine containing pholcodine in the past year.

Warning from the WHO

On 23 March the World Health Organization issued a warning about pholcodine-containing products.

“The WHO confirmed that a possible life-threatening anaphylactic reaction can be triggered, even up to 12 months after taking a medicine containing pholcodine when neuromuscular blocking agents are used during anaesthetics.”

Neuromuscular blocking agents are used in many types of surgery including eye surgery, intubation, and in mechanical ventilation. DM/MC