Adcock Ingram Holdings has three months to withdraw all medicines containing dextropropoxyphene (DPP) after the Medicines Control Council (MCC) cancelled the South African registration of such medicines.
This follows Adcock’s suspension of sales of Synap Forte, Lentogesic and Doxyfene at the end of last year. These products added almost R200m to revenues for the financial year to end-September.
In November the American Food & Drug Administration (FDA) withdrew DPP, which has analgesic properties, from the US market.
In an investigation the FDA found that DPP’s safety risks outweighed its analgesic benefits. The FDA asked suppliers to voluntarily remove all medicines containing DPP from the American market.
After the FDA announcement Adcock, South Africa’s second-largest pharmaceutical group, discussed the US findings with the MCC, as well as the drug’s potential consequences for local patient safety.
Adcock recently resumed sales of the products, but included extensive consumer information.
The group said it had received the MCC’s cancellation, but without any explanation.
According to Adcock, independent data had shown that none of the products involved had led to any increase in heart-related conditions in South Africa.
In Australia and France DPP products had not been withdrawn from the market and Adcock’s board had therefore decided to appeal the MCC decision. - (Sake24.com, April 2011)