Fear about the safety of popular pain killers has led to a ban on the sale of Synap Forte, Lentogesic and Doxyfene ordered by Judge Eberhardt Berelsmann in the Pretoria High Court yesterday.
Despite the ruling, Adcock Ingram, the pharmaceutical manufacturer, rejects that these medicines containing the controversial ingredient dextropropoxyphene (DPP) are so-called "killer drugs".
In April this year, the Medicines Control Council (MCC) withdrew the registration of medicine containing DPP after tighter regulation was implemented in other countries. Last year DPP-containing medicine was withdrawn from the US market due to claims that the benefits of DPP for pain relief at US recommended doses outweighed the safety risk.
In reviewing the safety and effectiveness of DPP-containing medicines, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded in 2009 that the risks of these medicines were far greater than the benefits, and sent their recommendations to the European commission for a legally binding decision.
However, Adcock Ingram claims that DPP-containing drugs tested overseas are not formulated in the same way as those used in South Africa. "Critically, there is no evidence of cardio-toxicity in SA safety data," Prudence Mbatha said in an press release from the pharmaceutical giant.
The withdrawal of the medication was largely owing to reports of side effects and adverse events like addiction, arrhythmias (irregular heartbeats) and alcohol-related deaths, which raised serious questions about safety. A statement by the European Medical Agency also indicated that the difference between the dose needed for treating a patient and an overdose was very small.
The Times Live reported that Health Minister Aaron Motsoaledi was "ecstatic" over the ruling. "We don't understand why - for the sake of profits - a pharmaceutical company puts a product on the market when we asked them not to," he said.
And despite claims by Adcock Ingram that the product has been safely used for 30 years, Motsoaledi said that "when it comes to human life you always err on the side of caution".
The situation in SA
In South Africa, DPP-containing medicines are classed as schedule 5, which means it is a controlled substance that can only be obtained with a doctor's prescription. DPP-containing medicines have been available in South Africa for over 30 years and are primarily used in hospitals for post-operative pain relief, particularly for gynaecological and orthopaedic procedures.
The most popular of the three drugs, Synap Forte has sold more than 50 million tablets in South Africa in the past 10 years, according to Times Live, and is even routinely prescribed to pregnant women.
DPP a money-maker
Gilbert Marcus, who argued the case for the MCC, said that DPP-containing medicines generated an annual turnover of R182 million for the pharmaceutical company. "One cannot take chances with lives in the face of the evidence. Profits loom large in this matter," he said.
Ben Bredenkamp, for Adcock Ingram, said that although a lot of money was at stake, the main driver behind Adcock Ingram's appeal was to defend the company's reputation. He argued that the medicines had been sold in South Africa for years without any apparent negative effects.
"Adcock Ingram places the health of patients at the centre of its business. At no stage would Adcock Ingram ever compromise on this ethic."
- (Sapa/Times Live/Health24, November 2011)