Johannesburg - Pharmaceutical company Adcock Ingram Holdings [JSE:AIP] will review the Medicines Control Council's (MCC) decision to cancel the registration of all pain medicines containing the pain-relieving ingredient Dextropropoxyphene (DPP).
"The MCC has not provided comprehensive reasons why it decided to cancel the registrations," the company said in a statement on Wednesday.
"It did however state that the company had three months to withdraw the DPP-containing medicines from the market."
The medicines include Synap Forte, Lentogesic and Doxyfene.
"Although overseas there have been recent reports that DPP may lead to heart arrhythmias (irregular heartbeat), independent pharmacovigilance, toxicology and poison centre data have not indicated increased adverse cardiac events in patients taking Synap Forte, Doxyfene or Lentogesic in South Africa."
Adcock recently resumed selling its DPP-containing medicines. The company intended lodging an appeal with the MCC.
Due to the safety concerns and in line with the new Consumer Protection Act, the company updated prescriber information with increased safety precautions, and reduced the number of tablets per pack to further encourage responsible use.
Among other countries, Australia and France continue to have DPP-containing products on the market.
The US Food and Drug Administration (FDA) withdrew DPP from the US market in 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.
"The MCC has not provided comprehensive reasons why it decided to cancel the registrations," the company said in a statement on Wednesday.
"It did however state that the company had three months to withdraw the DPP-containing medicines from the market."
The medicines include Synap Forte, Lentogesic and Doxyfene.
"Although overseas there have been recent reports that DPP may lead to heart arrhythmias (irregular heartbeat), independent pharmacovigilance, toxicology and poison centre data have not indicated increased adverse cardiac events in patients taking Synap Forte, Doxyfene or Lentogesic in South Africa."
Adcock recently resumed selling its DPP-containing medicines. The company intended lodging an appeal with the MCC.
Due to the safety concerns and in line with the new Consumer Protection Act, the company updated prescriber information with increased safety precautions, and reduced the number of tablets per pack to further encourage responsible use.
Among other countries, Australia and France continue to have DPP-containing products on the market.
The US Food and Drug Administration (FDA) withdrew DPP from the US market in 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.