Two German drug companies are selling a painkiller, banned in their own country, to South Africans, reports Ann Eveleth
One of the world’s leading pharmaceutical manufacturers continues to sell substantial quantities of a painkiller in South Africa which has been banned in its home country – and which some critics estimate could kill up to 2 000 people a year worldwide.
German-based manufacturer Hoechst Marion Roussel confirmed this week that it sold more than R500 000 worth of tablets and injectible solutions containing the controversial analgesic dipyrone to South Africans last year. This year’s sales of the drug Norifortan, which contains dipyrone, had topped R400000 by the end of August, said Hoechst medical director Dr Christo Van Niekerk.
The company developed the drug as an alternative to aspirin and paracetemol. But studies have linked it to deadly side- effects.
The Side Effects of Drugs Annual says it is “reasonable to suggest that there could be at least 2 000 deaths a year globally from dipyrone”, as fatality rates of up to 73% have been reported in developing countries which are now dipyrone’s major markets.
German health authorities withdrew all combination drugs which, like Norifortan, contain dipyrone mixed with other drugs from the domestic market in 1987. The move followed the death of 94 German users of the drug between 1981 and 1986.
Subsequent studies and public hearings into dipyrone’s safety led German drug regulators in 1990 to issue “an order banning all combination products containing dipyrone and re-emphasise its view that [pure] mono-preparations of dipyrone were drugs of last resort, primarily for tumour pain”, according to a 1993 publication of the Dutch-based non-governmental drug watchers, Health Action International.
Concerns over the risk of death from anaphylactic shock (caused by allergic reaction) and agranulocytosis, an immune- deficiency disease caused by severe loss of white blood cells and destruction of bone marrow, led the United States Food and Drug Administration to withdraw dipyrone as far back as 1977.
Dipyrone has since been banned or severely restricted in Australia, Bangladesh, Canada, Denmark, Egypt, Fiji, Germany, Greece, Ireland, Israel, Italy, Japan, Malaysia, New Zealand, Norway, the Philippines, Saudi Arabia, Singapore, Sweden, the United Kingdom, the US and Venezuela, according to Health Action International.
But South Africa’s Medicines Control Council (MCC) decided otherwise. Council chair Dr Peter Folb this week defended the drug’s continued presence on the market, saying: “It was [the MCC’s] considered opinion that used in only specified, limited circumstances, it still has value in South Africa.”
In its pure form – as it is strictly available in Germany, Sweden and other countries – dipyrone is used to quell severe pain, such as that experienced by cancer patients. In combinations with anti- spasmodics (muscle-relaxants) available in South Africa, the drug is prescribed for a wider array of health problems, including stomach, gastro-intestinal and urinary colic, as well as dysmenorrhoea (menstrual pain), according to the South African package insert for Norifortan.
Hoechst’s Van Niekerk, however, defended the continued sale of the drug in South Africa, arguing that it was still a registered drug “in many countries” and that the incidence of dipyrone-linked agranulocytosis was “very low”. Van Niekerk’s view reflects an ongoing controversy over the drug’s dangers which has raged for more than a decade between manufacturers, who claim the risk is only one in a million users a week, and other health professionals like Health Action International, who say the risk is as high as one in 25000 users.
Health Action International, which has campaigned for a global ban on dipyrone (and more than a dozen other names it appears under), points out that while the drug may be “bad health”, it is “good business”, having earned the industry more than $190-million in 1987 and accounting for just over 5% of total world drug sales in the year it was withdrawn from Germany, with most of these profits emanating from the developing world.
Folb said he did not see anything unethical about companies selling drugs banned at home to developingmarkets. “We don’t have any product dumping here because we have strict regulatory procedures,” he said.
Van Niekerk pointed out that Hoechst is not alone in continuing to market the drug, as “other companies also sell similar products in South Africa”. He is correct.
Hoechst’s German competitor, Ingelheim Pharmaceuticals, produces the dipyrone combination drug Buscopan Co for the local market. And South African-based Adcock Ingram markets a similar drug called Scopex Co. According to Clint Prince, sales manager for Scopex Co, there was a “big demand” for the drug locally, amounting to about 2,4-million tablets sold a month. Ingelheim had not responded to queries about its product by the time of publication.
Introduced to the South African market more than 30 years ago, dipyrone’s South African registration will – like all other drugs – come under review every five years if Parliament adopts the Medicines Control Amendment Bill currently under debate.
In the meantime, the Department of Health’s chief director in charge of drug policy, Bada Pharasi, undertook this week to investigate “whether adverse affects from dipyrone have occurred in South Africa”.