The Medicines Control Council (MCC) resolved at its meeting on 14 to 15 April 2011 to withdraw all dextropropoxyphene containing medicines from the South African market due to safety risks.
Dextropropoxyphene is present in the following medicines: Distalegisic, Doloxene, Doloxene CO-65, Doxyfene, Lentogesic and Synap Forte which are used to treat pain.
Dextropropoxyphene causes dose-related cardiac conduction abnormalities which could lead to dangerous irregularities in heart rhythm and rate, including cardiac arrest and death. These adverse effects on the heart have been observed even in healthy young adults and at usual dosages.
Dextropropoxyphene and its active breakdown metabolic product are excreted by the kidneys so the elderly and those with impaired renal function would be especially vulnerable as these products can accumulate and reach toxic levels.
Several countries have already withdrawn medicines containing dextropropoxyphene and these include the USA, UK and EU-member states among others.
The MCC has allowed a three-month grace period to allow for smooth transition of patients to alternative pain relief treatment. Patients currently taking medicines containing dextropropoxyphene are requested to contact their doctors as soon as possible to obtain advice about stopping these medicines and alternative pain relief treatment.
For more information please contact:
Fidel Hadebe
Tel: 012 395 8493
Cell: 079 517 3333
Issued on behalf of the Medicines Control Council (MCC)
