GSK Faces Ethical Headache Over Recall of Key Pain Drug
Add comment July 6th, 2007
Hedex Extra was meant to be the drug that pushed the envelope for millions of low-income Kenyan blue-collar workers shopping for a pain reliever.
It was heavily marketed as one of the country’s most potent painkillers, but now global pharmaceutical giant GlaxoSmithKline (GSK) is having a headache over the recall of this product.
Yesterday, it emerged that GSK is investigating a possible factory slip up that resulted in an error in its formulation—under the watch of the industry regulator, Kenya’s Pharmacy and Poisons Board.
But GSK said in a faxed statement that the product had been incorrectly stored in excessive temperatures above 30 degrees, causing the breakdown of the ingredient aspirin to form crystals of salicylic acid.
“Ingesting a dose of Hedex Extra damaged through incorrect storage may cause irritation to the mouth, throat and stomach.”
Hedex Extra was also meant to turbo-charge the growth of GlaxoSmithKline’s block-buster painkiller, Hedex, which was facing intense competition in the low end of the market, a category that was increasingly coming under competition from lower price name brand drugs, a host of generics and even fakes.
Just like GSK’s other pain relief brand, Panadol and Panadol Extra that targets more affluent consumers, Hedex Extra was launched as a product extension to Hedex, a companion and fighter brand against the likes of Beta Healthcare’s Mara Moja and Action in a bid to carve a bigger share of Kenya’s Sh2 billion analgesic drug market.
However, by the time Hedex Extra was brought to the market in January 2006, insiders knew that there were problems with the product’s formulation and there had been consumer complaints over the side effects of the drug.
It had been specially formulated for the Kenyan market with an extra pain relief strength than is usually marketed in Europe and other African markets.
Yesterday, it emerged in media reports that GSK had recalled Hedex Extra from the market. Business Daily’s interviews with retailers and pharmacists reveal that GSK started withdrawing the drug from the market in March and as late as last month.
Kenya’s Poisons and Pharmacy Board, which regulates the manufacture and marketing of drugs, confirmed that GSK started recalling the product in March. Until yesterday, GSK had not issued a public announcement over the product recall as industry standards requires in global medical marketing.
“In March, it was brought to our attention that there was a problem with Hedex Extra,” said Dr Wilfred Ochieng, Head of the Inspectorate division at the Pharmacy and Poisons Board, the governing body of the pharmaceutical industry.
However, on Thursday, GSK said the drug had been recalled because of Acetyl Salicylic Acid was breaking down too fast releasing a by-product in unusually high concentrations than was medically allowed. This was making consumers who take it to experience severe irritation in the mouth and throats and even causing stomach upsets. This was after the company says that it received complaints from Mombasa.
A super strong pain killer, it contained a heady mix of paracetamol, aspirin and caffeine and was marketed as providing extra fast relief for not just head aches, but also migraines, back aches and tooth aches.
“The issue is currently being investigated by its manufacturers. Just four batches had a problem. We decided in liaison with GSK that it would be best to withdraw the product pending investigations,” said Dr Ochieng, “The recall of the product does not mean Hedex Extra is bad for consumers, it just means there is a slight defect, which can be resolved in time.”
A possible problem in its formulation could be to blame for the drug manufacturers latest headache with the product.
Dr Ochieng said factors leading up to the recall could be rooted in factory issues, confirming it was a stability issue, a phenomenon that makes Asprin start degenerating turning a normally harmless drug into a toxic one.
The Kenyan version of the drug — it is sold in varying strengths in different countries around the world — was specially formulated for the local market.
Industry players say it contained the largest admissible amounts of its various components allowed under the law.
“I believe it should have been offered in a single dose rather than in the usual double pack. It was really powerful,” said a pharmacist, who declined to be named.
The Kenyan version of Hedex Extra was the result of several years of research for the multi-national drug company. It was however more powerful than a similar product sold in other markets.
The drug was slated to be a front-runner for the British pharmaceutical firm in the highly competitive analgesics market, where generics are taking a bite out of GSK’s profits from its flagship Panadol.
The struggle to gain a share in Kenya’s Sh2 billion over-the-counter painkillers market has occupied both international and local manufacturers, who are competing against counterfeits and a growing generic presence.
In a country where 60 per cent of the population self-medicates, Hedex Extra was positioned to take on Mara Moja — produced by locally based competitor Beta Heathcare — and the growing generic segment on its strong formulation claim.
Kenya’s over the counter (OTC) market has attracted several major international pharmaceutical firms such as: GSK, AstraZeneca Group Plc, Novartis Consumer Health SA, Pfizer Consumer Healthcare Inc, Aventis SA, and Sanofi Winthrop Industries. There are also a number of local manufacturers such as Beta Healthcare and Dawa Pharmaceuticals.
Within the pain relief category, local firms now control over 80 per cent of sales. Companies like GSK manage to maintain their share through a mix of higher pricing models, guarantees on quality and aggressive marketing.
Hedex Extra rode the back of a localized marketing campaign Boda Boda (bicycle taxi) challenge after sponsorship of its successful soccer fiesta, Hedex Cup was cancelled.
GSK is the oldest company in OTC health care in Kenya, with annual sales said to total over US$400 million per year, according to research firm, Euromonitor. The company is aggressively fighting off the rising generic wave with market share figures reportedly falling from 52 per cent in 2005.
Last year, the British pharmaceutical firm staved off a potential recall of its famed Panadol brand, which was under scrutiny in other countries after one batch was withdrawn from the market.
The Pharmacy and Poisons Board have withdrawn two other products from the market in the last two years.
One, nimesulide, was a key component of children’s cold and flu medications and was withdrawn following an international ban of the product. The other was an infection depressant.
Globally, other big pharmaceutical firms have recalled back their painkillers after disastrous accidents. In the early 1980s, seven people in the Chicago area died after they took Extra-Strength Tylenol, an analgesic. Johnson & Johnson, its manufacturers, immediately pulled 31 million bottles of the painkiller, with an estimated retail value of more than US$100 million.
Source: http://www.bdafrica.com/index.php
