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Johannesburg - The Medicines Control Council (MCC) has given a three-month grace period to remove medicines containing the pain-relieving ingredient dextropropoxyphene from the market, a spokesperson said on Tuesday.
"The MCC has allowed a three-month grace period to allow for smooth transition of patients to alternative pain relief treatment," Fidel Hadebe said.
"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."
The MCC resolved on in April to withdraw the medication due to safety risks.
Dextropropoxyphene is found in the following medicines used to treat pain: Distalegisic, Doloxene, Doloxene CO-65, Doxyfene, Lentogesic and Synap Forte.
"Dextropropoxyphene causes dose-related cardiac conduction abnormalities which could lead to dangerous irregularities in heart rhythm and rate, including cardiac arrest and death," Hadebe said.
The adverse effects had been observed in healthy, young adults taking normal 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."
The department said several countries, including the US, UK and Eurpean Union-member states had already withdrawn medicines containing dextropropoxyphene.
"The MCC has allowed a three-month grace period to allow for smooth transition of patients to alternative pain relief treatment," Fidel Hadebe said.
"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."
The MCC resolved on in April to withdraw the medication due to safety risks.
Dextropropoxyphene is found in the following medicines used to treat pain: Distalegisic, Doloxene, Doloxene CO-65, Doxyfene, Lentogesic and Synap Forte.
"Dextropropoxyphene causes dose-related cardiac conduction abnormalities which could lead to dangerous irregularities in heart rhythm and rate, including cardiac arrest and death," Hadebe said.
The adverse effects had been observed in healthy, young adults taking normal 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."
The department said several countries, including the US, UK and Eurpean Union-member states had already withdrawn medicines containing dextropropoxyphene.
