Posted by: maboulette | November 19, 2011


Trade Name: Doloxene - 100 mg - dextropropoxyp...

JOHANNESBURG – A pharmaceutical manufacturer in South African is combating attempts toward the banning of a painkiller that has already been taken off the market in the United States and Europe due to fears of it causing heart problems.

Authorities in South Africa have progressed to join companies in the U.S. and Europe to stop the sales of dextropropoxyphene after over decades of use, but the manufacturer in South Africa, Adcock Ingram assert that the drug is safe.

“We always maintained that the drug is safe, and still maintain the drug is safe,” Dr. Abofele Khoele, Adcock Ingram’s medical executive, said during an interview held Thursday.  “We’ve got studies to prove the drug is safe.”

But he did admit that dextropropoxyphene which is found in Adcock Ingram painkillers Doxyfene and Synap Forte, has caused problems elsewhere.

The company is appealing an April ruling by South Africa’s Medicines Control Council on the drug. This week, the company lost a bid in court to let doctors keep prescribing dextropropoxyphene products while awaiting a ruling on the appeal.

Health Ministry spokesman Fidel Hadebe told The Associated Press the court ruling “is a major victory for the public. Government has a duty to protect the public from any possible medical harm.”

Hadebe could not say exactly when a Health Ministry appeal body would make a ruling on Adcock Ingram’s request for a quick decision on a review.

Last year, the U.S. Food and Drug Administration asked companies to voluntarily halt selling dextropropoxyphene products, Xanodyne Pharmaceuticals withdrew Darvon and Davocet, brand name versions of the drug from U.S. markets.

The FDA had concluded that the pain medication “can cause serious toxicity to the heart” and “puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.”

In 2009, the European Medicines Agency recommended that all marketing authorizations for medicines containing dextropropoxyphene be withdrawn throughout the European Union.

“I think our regulators should take note of the goings on around the world,” Khoele said.

But he also added that South African regulators should have gotten information from local manufacturers before making a decision since they maintain that the drug as well as dosages are made differently in their country.

Khoele said that the company would accept the decision of the appeal board.

Source Associated Press 

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