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Johannesburg - Healthcare company Adcock Ingram Holdings [JSE:AIP] on Friday confirmed that it had suspended promotion and sales of its dextropropoxyphene (DPP)-containing medicines in SA.
Shares of the drugmaker tumbled 2.3% to R64.98 after it said South Africa would ban drugs containing the pain-killer dextropropoxyphene, or DPP, on safety concerns.
The US Food and Drug Administration (FDA) withdrew DPP from the US market on November 19, after the FDA determined that the safety risk of DPP for pain relief at US recommended doses outweighed the benefits and as such the regulator requested that suppliers voluntarily withdraw any drugs containing DPP from the US market.
According to media reports, new research showed the drug was linked to serious abnormal heart rhythms.
In June 2009, the propoxyphene-containing products were banned in the European Union because of fatal overdoses. The UK banned it in 2005.
DPP is a compound with pain-relieving properties that is found in three of Adcock Ingram's drugs - Synap Forte, Lentogesic and Doxyfene, the group said.
Synap Forte is a popular medicine to relieve pain, particularly after operations and for back pain.
Following the FDA announcement, Adcock Ingram said it engaged in discussions with the Medicines Control Council (MCC) of the department of health relating to the implications of the US data to patient safety in South Africa.
"Adcock Ingram has now become aware that the MCC has resolved, inter alia, that all DPP containing medicines be withdrawn from the South African market," it said.
Adcock Ingram noted that its drugs containing DPP contributed approximately R200m to its revenue for the financial year ended September 30 2010.
"Adcock Ingram has not, as yet, received any formal communication from the MCC regarding withdrawal of its DPP containing medicines," it said.
Click here to learn more about what your prescription says.
Shares of the drugmaker tumbled 2.3% to R64.98 after it said South Africa would ban drugs containing the pain-killer dextropropoxyphene, or DPP, on safety concerns.
The US Food and Drug Administration (FDA) withdrew DPP from the US market on November 19, after the FDA determined that the safety risk of DPP for pain relief at US recommended doses outweighed the benefits and as such the regulator requested that suppliers voluntarily withdraw any drugs containing DPP from the US market.
According to media reports, new research showed the drug was linked to serious abnormal heart rhythms.
In June 2009, the propoxyphene-containing products were banned in the European Union because of fatal overdoses. The UK banned it in 2005.
DPP is a compound with pain-relieving properties that is found in three of Adcock Ingram's drugs - Synap Forte, Lentogesic and Doxyfene, the group said.
Synap Forte is a popular medicine to relieve pain, particularly after operations and for back pain.
Following the FDA announcement, Adcock Ingram said it engaged in discussions with the Medicines Control Council (MCC) of the department of health relating to the implications of the US data to patient safety in South Africa.
"Adcock Ingram has now become aware that the MCC has resolved, inter alia, that all DPP containing medicines be withdrawn from the South African market," it said.
Adcock Ingram noted that its drugs containing DPP contributed approximately R200m to its revenue for the financial year ended September 30 2010.
"Adcock Ingram has not, as yet, received any formal communication from the MCC regarding withdrawal of its DPP containing medicines," it said.
Click here to learn more about what your prescription says.
