Headache over painkiller ban

2011-11-19 16:30

This week’s court ruling banning a popular painkiller, Synap Forte, is causing a headache for its manufacturer (and the government).

Adcock Ingram, a leading South African pharmaceutical company selling the painkiller containing DPP (drug dextropropoxyphene), and the department of health are at loggerheads over the impact of Tuesday’s ruling by the North Gauteng High Court in Pretoria.

The ministry says Synap Forte should have been off chemists’ shelves by Wednesday morning, but the manufacturer claims it has until the end of next month to remove the banned drug.

DPP may cause serious damage to heart muscles, inhibiting the heart from supplying blood in normal quantities and deadly heart failure in higher doses. Concerns over this active ingredient have previously prompted stringent drug regulatory authorities in the European Union, US and the UK.

Adcock halted manufacturing and selling of Synap Forte, Lentogesic and Doxyfene after the ruling. This after the court found that an agreement reached between lawyers representing the Medicines Control Council (MCC) and Adcock was unlawful.

The agreement allowed the company to continue producing and marketing the drug despite it being banned. The court held that the agreement was never approved by the minister of health and the council’s executive committee.

All pain-relief drugs containing DPP were banned by the ministry after US and UK studies showed it caused cardiac arrest and could lead to death in the case of an overdose.

Dr Abofele Bogosi Khoele, a medical executive at Adcock, insisted this week that the council had given his company three months to clear stock that was ­already on the market.

“Pharmacists can still dispense the medicine already in their possession. They can do so until December 28. Thereafter, Adcock will collect what is left,” he said.

But department spokesperson Fidel Hadebe said pharmacists who dispensed the banned drugs would be breaking the law. “All medicine containing DPP must be withdrawn from the market with immediate effect. What Adcock is doing is in violation of the MCC’s decision and the court ruling.”

This confusion has left pharmacists in the dark. Peter Puka, a pharmacist in Dobsonville, Soweto, said he had about 30 boxes of Synap Forte in stock and didn’t know what to do with them.

“I thought the ruling meant that the medicine has been discontinued with immediate effect. I am surprised Adcock says we have until the end of December,” said Puka.

Another Soweto pharmacist, Psycho Ramosibudi, said: “This is frustrating because all parties are sending different messages.”

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