Synap Forte is also banned in Botswana - MoH

MARANYANE NGWANAAMOTHO
Staff Writer | Tuesday November 22, 2011 00:00

Infact, a spokesman of the Ministry of Health (MoH) says the 'importation of these medicines is not allowed'.

In response to a Mmegi questionnaire that was prompted by a decision of a South African court banning the drug, MoH responded:

'On January 18, 2011, a letter was written to all pharmaceutical wholesalers, community pharmacies, health facilities and doctors to inform them that all products which contain the active ingredient Dextropropoxyphene be withdrawn from the market with immediate effect due to safety concerns.'

The ministry's principal public relations officer, Temba Sibanda, has explained that as soon as the Pretoria High Court slapped a ban on the drug, companies and all concerned were requested to recall and return the medicines to their suppliers.

'It is expected that the medicines are not in the country,' Sibanda says.

'The ministry, through the Drugs Advisory Board and the Drugs Regulatory Unit, regulates the medicines.

 'One aspect of regulation of medicines is post-marketing surveillance to monitor and assess the benefits and risks of all the medicines when used over a long period on a large population, with other medicines and disease conditions (sic).

'When it is established that the risks outweigh the benefits, the Drugs Advisory Board recommends to the ministry appropriate action to be taken and the ministry informs health professionals of the risks and action taken, including banning the use of such medicines,' Sibanda says.

In banning the drug, Justice Eberhardt Bertelsmann of the Pretoria High Court withdrew an earlier court order that allowed its continued sale pending the outcome of an appeal by pharmaceuticals giant, Adcock Ingram.

Similar bans have been slapped on Synap Forte and associated drugs Lentogesic, Doloxene and Dolofene in the US and the EU over the past two years.

The widespread ban followed a study that showed that the drugs increase the risk of heart attacks. South Africa's Minister of Health, Dr Aaron Motsoaledi, reportedly received news of the ban with joy.

'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.

After the ruling, pharmaceuticals giant Adcock Ingram said it rejected 'in the strongest possible terms any arguments that DPP-containing products were 'killer drugs.''

The company said 'DPP-containing drugs tested overseas are not the same formulation as those used in South Africa'.

Synap Forte is a popular prescription drug. Up to 50 million tablets have been sold in South Africa in the past 10 years. It is routinely prescribed for pregnant women and to people who have undergone surgery.

A spokesman for South Africa's HIV/Aids activist group Treatment Action Campaign, Mark Heywood, said the judgment was a 'good outcome'. He said attempts by Adcock Ingram to produce its own studies on the side effects of Synap Forte - which display favourable results - were a form of misbehaviour.

'They are being misleading and deceptive,' he said, referring to a study of 30 patients by the company that found no increased risk of heart attacks.On April 15, South Africa's Medicines Control Council banned all drugs containing DPP because they 'could lead to dangerous irregularities in heart rhythm and rate, including cardiac arrest and death'.  (Additional reporting by timeslive.co.za)