Healthcare company Adcock Ingram Holdings confirmed it had withdrawn its dextro propoxyphene (DPP)-containing medicines from the South African market, Fin24 reported. The three products are Synap Forte, Lentogesic and Doxyfene, that are used for pain relief.
The US Food and Drug Administration withdrew DPP from the US market on November 19, after determining that the benefits of DPP for pain relief at US-recommended doses did not outweigh the safety risk.
The regulator requested that suppliers voluntarily withdraw any drugs containing DPP from the US market.
Adcock Ingram received notification from the MCC relating to the withdrawal of DPP-containing medicines. The MCC has resolved that all DPP containing medicines be withdrawn from the market, that there will be no new prescriptions of DPP allowed; and for patients for whom DPP containing medicines cannot be withdrawn immediately, a 3 month change over period will be permitted during which patients should be switched to an alternative therapy.
Adcock Ingram has suspended all promotion and sales of DPP containing products pending further interaction with the MCC. The company will work with the MCC to formulate and execute a plan going forward to ensure continued safety of South African patients.
Serious abnormal heart rhythms
According to media reports, new research showed the drug was linked to serious abnormal heart rhythms. According to a 2009-report by the European Medicines Agency (EMA) DPP-containing medicines were weak painkillers, and only have limited effectiveness in the treatment of pain.
In terms of safety concerns, the EMA found that the difference between the dose needed to treat the patient and the dose that could harm the patient is small. "Patients may easily take too much dextropropoxyphene and risk a fatal overdose, as dextropropoxyphene can be rapidly fatal," reads the EMA report.
These Adcock Ingram drugs containing DPP contributed approximately R200 million to the company's revenue for the financial year ended 30 September 2010. - (Health24/Sapa, December 2010)