Many healthcare organisations around the country have supported the South African Medicines Control Council (MCC) decision to withdraw dextropropoxyphene (DPP).
The MCC’s decision followed an announcement in late 010 by the United States Food and Drug Administration (FDA) to withdraw drugs containing this pain relieving ingredient from the US market.
It was noted that the FDA determined that the benefits of DPP for pain relief at US recommended doses outweighed the safety risk, and requested that suppliers voluntarily withdraw any drugs containing DPP from the US market.
In reviewing the safety and effectiveness of DPP-containing medicines, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded in 2009 that the risks of these medicines were far greater than the benefits, and sent their recommendations to the European commission for a legally binding decision.
The situation in SA
Classed as Schedule 5 drugs in South Africa – which means a controlled substance, medicines containing DPP have been available in South Africa for over 30 years. These painkillers are primarily used in hospitals for post-operative pain relief, particularly for gynaecological and orthopaedic procedures.
With the MCC’s decision to withdraw the DPP compound, many medical practitioners are concerned for patient welfare, as well as what to prescribe for this kind of pain management, particularly because this type of pain medication has been so commonly prescribed in South Africa.
This has led to healthcare professionals seeking alternatives for acute pain management. The next most commonly used prescribed medication contain a combination of tramadol and paracetamol, or codeine, paracetamol and ibuprofen. These combinations are pharmacologically sound as they they consist of only proven analgesic substances combined in lower doses.
This ensures better pain management with reduced side effects, compared to when the individual agents are used alone.
'Risks outweigh the benefits'
The South African pain killer market is valued at approximately half a billion rand, with almost one third of this market attributable to products containing dextropropoxyphene. The withdrawal of the medication was largely due reports of side effects and adverse events like addiction, arrhythmias (irregular heartbeats) and alcohol related deaths, which raised serious questions about safety.
Dextropropoxyphene has been previously linked to opioid dependence.
In the South African Guidelines for the Management of Opioid Dependence, compiled by Lize Weich, Charles Perkel, Nicolette van Zyl, Prof Rataemane, and Lochan Naidoo; it is stated that 4% to 12% of treatment seekers in addiction treatment facilities are seeking therapy for over-the-counter or prescription medication abuse, including DPP, as their primary or secondary drug of choice.
Professor Lomby Odendaal of the Department of Anaesthesiology, School of Medicine at the University of the Free State, has welcomed the decision to withdraw DPP. “For many years I have spoken about the unrealistic combination analgesics that are available in South Africa, where the risks outweigh the benefits,” he says.
“Furthermore, there are still combinations available that contain dangerous substances like meprobamate, which is highly addictive. Drugs like antihistamines should also not be in the combination for analgesia (pain management),” Prof Odendaal asserts. “They have no analgesic properties and may cause severe motor and emotional side-effects when taken with other substances like alcohol in normal doses.”
The available options
So, what are the available options available to medical practitioners who wish to manage pain appropriately, following the World Health Organisation guidelines, and to ensure patient compliance? Prof Odendaal says that commonly used prescribed combinations contain tramadol and paracetamol or codeine, paracetamol, and ibuprofen.
“A fixed combination of tramadol and paracetamol at a fairly low dose, may serve as a good replacement for dextropropoxyphene-containing drugs. The reason for this low dose combination is that they act synergistically (work together) with an efficient increased pain-killing effect than that when given alone. The side-effect profile is also very low.
“If one wants to use any other combination, make sure that the combination affects the receptors that are involved in pain, for example μ-receptors, peripheral acting drugs like the nonsteroidal anti-inflammatory drugs (NSAIDs) or central acting drugs like paracetamol,” Professor Odendaal concludes.
Anyone with concerns about their medication should consult their medical professional for advice.
Non-steriodal anti-inflammatory medication