Painkiller now an 'illegal' drug

Boxes of pain-relief drug Synap Forte remained on chemists' shelves last night as major pharmacy chains waited for the Medicines Control Council to order them to remove them.

The sale of Synap Forte and drugs such as Lentogesic, Doloxene and Doxyfene - all of which contain dextropropoxyphene (DPP) - was banned by the Pretoria High Court yesterday when Judge Eberhardt Bertelsmann rescinded an order of the court that had allowed the continued sale of the drugs pending the outcome of an appeal by pharmaceuticals giant Adcock Ingram.

There have been similar bans in the US, the UK and EU countries in the past two years.

The drug was banned after a study showed that it increases the risk of heart attacks.

Health Minister Aaron Motsoaledi said last night that he 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.

After yesterday's ruling, Adcock Ingram said it rejected "in the strongest possible terms any arguments that DPP-containing products are so-called 'killer drugs'."

But Motsoaledi said that "when it comes to human life you always err on the side of caution".

Synap Forte is a popular prescription drug and up to 50million tablets have been sold in South Africa in the past 10 years.

It is routinely prescribed to pregnant women and to people who have undergone surgery.

Judge Bertelsmann yesterday disallowed a settlement between the Department of Health's lawyers and Adcock that allowed Adcock to continue to sell the drugs pending a decision by the Medicines Control Council's appeals committee.

In court yesterday, Adcock's lawyer, Ben Bredenkamp, told the judge that the company's reputation was at stake.

But the council said that it had been considering the risks associated with dextropropoxyphene for several years.

Adcock Ingram announced after the ruling that it had "voluntarily suspended" sales of the products and called for consideration of its appeal to be "accelerated".

Adcock spokesman Prudence Mbatha said: "DPP-containing drugs tested overseas are not the same formulation as those used in South Africa."

A spokesman for HIV/Aids activist group Treatment Action Campaign, Mark Heywood, said that the judgment was a "good outcome".

He said that attempts by Adcock to produce its own studies on the side-effects of Synap Forte - which display favourable results - was a form of misbehaviour.

"They are being misleading and deceptive," he said in reference to a study of 30 patients by the company that found no increased risk of heart attacks.

On April 15, the Medicines Control Council banned all drugs containing dextropropoxyphene because they "could lead to dangerous irregularities in heart rhythm and rate, including cardiac arrest and death".

But the following month Adcock launched an appeal against the ban and continued to supply the drugs to pharmacies.

Before the appeal was concluded, the council warned doctors about the drug. Adcock representatives then went to the Pretoria High Court, claiming they had been prejudiced.

Last month, the state attorney - acting against instructions - struck an out-of-court settlement with Adcock, allowing it to continue distributing its products until the appeal was finalised.

The council's new lawyers told the court yesterday that the settlement exposed the public to harm, and Bertelsmann agreed.

"The court must express dismay against the state attorney for entering into the settlement. I hope this never occurs again. After all, the attorney is the custodian of public funds," said Bertelsmann.

Natasha Neveling, dispensary manager of major pharmacy chain Dischem, said Synap Forte was still on the chain's shelves - for now.

"As soon as we get the relevant information we will act accordingly to make sure we always comply," she said.

Retailer Clicks' MD, Michael Harvey, said that chain had "some prescriptions" for Synap Forte and would not remove it from the pharmacy shelves until the receipt of written notice from the council.

But Harvey said Clicks' sales of the drug had "slowed significantly" since April.

Johannesburg gynaecologist Birgit Bothner said that she had stopped prescribing DPP-containing drugs a few months ago because her clinic pharmacy had stopped supplying it.

But Synap Forte user Maurits Polak, 84, is far from pleased. He has been taking two tablets every morning and evening for 10 years for his arthritis and is allergic to all other pain medication.

"I can't walk further than across the road [without taking the pills]; after that I start having pain in my ankles, legs and thighs," he said.

"I'm 84 and I've been using it for 10 years. I've had no side effects at all."