PHOLTEX SYRUP Range: Pholtex Junior; Pholtex Forte and Pholtex Plus

(Pholcodine 5 mg, Pholcodine 15 mg and Pholcodine 5 mg; Phenylephrine HCl 3.3 mg respectively)

Reason for recall

iNova Pharmaceuticals (Pty) Ltd, in consultation with the SAHPRA has taken a decision to recall AND to withdraw all pholcodine containing medicines.

The decision to recall AND to withdraw is linked to a recently concluded French clinical study (the ALPHO Study) which reviewed a possible association between pholcodine and very rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBAs) used in anaesthesia. iNova, based on SAHPRA’s recommendation has agreed to recall all stock in the market & withdraw the product completely from the market.

Data from the ALPHO study indicates that the use of pholcodine in the 12 months leading up to anaesthesia using NMBAs increases the risk of developing an anaphylactic reaction. The relationship between pholcodine and anaphylactic reactions to NMBAs has been hypothesised over the last decade, however, until the ALPHO study, no association had previously been established in any clinical study globally. It is further confirmed that there is still no evidence showing causal risk. However, based on the available data, there are currently no possible effective risk minimization measures which have been identified to mitigate against this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh the risks. Due to these considerations and the nature of the adverse reactions (including its unpredictability and clear timelines to onset), SAHPRA has recommended the withdrawal of all pholcodine-containing medicines from the South African market.

Advice to HCPs/Distributors/Public:

• Distribution and sale of the above-mentioned products should be ceased immediately.
• All batches of Pholtex Junior, Pholtex Forte and Pholtex Plus are to be returned to wholesaler/distributor.
• Customers are requested to retain the notification letter and place it in a prominent position for one month in case stock is in transit.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all clients, stock is blocked for sale by all distributors and recall initiated. This incident has been reported to other Reg Authorities, namely: NMRC, MCAZ, ZAMRA and BoMRA.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.