Safey risk: Drug used in prescription painkillers withdrawn from South African market

2011-05-04 00:00

THE Medicines Control Council (MCC) has resolved to withdraw medicines containing dextropropoxyphene (DPP) — a variety of prescription painkillers — from the South African market after it was discovered that it poses safety risks.

The manufactures and owners of the drugs — Aspen and Adcock Ingram — have been informed of the decision, with the latter vowing to contest it.

MCC registrar Mandisa Hela said a number of countries — including the U.S. and Britain — have withdrawn medicines containing dextropropoxyphene.

“When every drug is registered with us we monitor it throughout its lifecycle. We also look at the benefit and risk profile of the drug and if there’s a need to phase it out we always find an alternative drug. During a scientific study into the drug we discovered that it has side-effects that could lead to irregularities in heart rhythm and rate, including cardiac arrest and death,” said Hela.

She said the manufacturers were given 30 days to indicate their intention and Aspen was happy with the phasing out.

“It’s a different story with Adcock as they indicated that they will contest this decision, but as we speak I haven’t received a written document since the withdrawal notice was issued.”

DPP is present in the medications Distalegisic, Doloxene, Doloxene CO-65, Doxyfene, Lentogesic and Synap Forte — which are all used to treat pain.

Its active breakdown metabolic products are excreted by the kidneys, so the elderly and those with impaired renal function would be especially vulnerable as these products can accumulate and reach toxic levels.

Hela said the MCC has allowed a three-month grace period to allow for a smooth transition of patients to alternative pain relief.

In a letter to healthcare professionals Adcock states that it will embark on “the most robust” clinical study to establish whether DPP-containing medicines have any clinically significant cardiac signals that warrant further investigation.

Local pharmacist Divesh Ram­dhass of Northway Family Care pharmacy said many patients use dextropropoxyphene-based drugs and doctors prescribe the type due to its effect in pain relief.

“Considering the identified risks involved, we’ve got to consider other options,” Ramdhass said.

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