Posted 01 November 2013
Consumers kept in dark about risky supplement
Sunday Times 27 October 2013
Local pharmacies pull product off shelves after Sunday Times investigation, writes Megan Power
The October 8 warning by the US Food and Drug Administration (FDA) for consumers to stop using any product labelled OxyElite Pro followed at least 20 cases in Hawaii of acute nonviral hepatitis linked to its use.
By Wednesday, this figure had grown to 39 and another seven cases were picked up in other US states. Now 10 more potential cases outside Hawaii are being investigated as part of a nationwide surveillance.
So far, 11 people have been hospitalised, two have had liver transplants and one has died.
But South African consumers have been kept in the dark.
The product’s exclusive South African distributor, Bolus Distribution, started informing retailers on Wednesday, hours after this newspaper’s inquiry. A day later, it posted the manufacturer’s denial of the claims on its website.
The Cape Town-based company has distributed the product since 2010.
Clicks withdrew the product immediately after being contacted by the Sunday Times. Dis-Chem did not. After consultation with the distributor and manufacturer, it said it did not believe it was “irresponsible” to continue stocking OxyElite Pro. “If there is deemed to be a safety risk, we will take prompt action,” health category manager Craig Fairweather said on Thursday.
But by Friday afternoon both Dis-Chem and Bolus Distribution had changed their tune, saying they would immediately remove the product as a “cautionary measure” pending the outcome of the US investigation. “We are the first country in the world adopting this philosophy [on the OxyElite Pro alert], but we feel that, in the interests of the consumer, it is the correct one,” said distributor Mike Bolus.
The Medicines Control Council, which approved the products imported by Bolus, was unaware of the issue. It has since launched an investigation.
“In light of the US alert, we will now analyse samples of the product, looking at the safety profile of each ingredient,” registrar Mandisa Hela said on Friday. “A statement will be issued once we know more.”
Long-awaited regulations that will force dietary supplements to be registered and provide tighter control of the industry are expected to be finalised by the end of the year.
In Hawaii, officials used their state embargo powers to remove the product from stores, and the FDA used its regulatory muscle to force manufacturer USPlabs to stop the distribution of the products pending the outcome of the investigation.
Its warning to consumers not to use OxyElite Pro has been echoed by health authorities worldwide, including in Britain, Europe, Australia and New Zealand.
USPlabs, however, has defended the product, saying the cluster of liver damage in Hawaii is “a complete mystery”.
“We know of no credible evidence linking OxyElite Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements,” its statement read.
The company told the FDA it believed that counterfeit versions of OxyElite Pro were being marketed in the US.
Itwas forced to discontinue its original version — containing the controversial stimulant DMAA (also known as 1.3dimethylamylamine) — earlier this year after the FDA received 86 reports of illness and death associated with the ingredient and declared it illegal.
Several replacement versions were then produced, most containing a new ingredient, aegeline. The FDA says the ingredient, derived from a citrus tree in Asia, has no history of use or evidence of safety.
In its warning letter to USPlabs on October 11, the FDA said that the failure to immediately cease distribution of all products containing aegeline could result in “enforcement action”, including the seizure of the product from stores.
FDA spokeswoman Shelly Burgess said this week that the products were deemed “adulterated” because they contained a new dietary ingredient for which there was no history of use or other evidence of safety for use in dietary supplements.
At least three formulations of the product have been sold in South Africa, some containing DMAA, yohimbe bark extract (the latter banned in South Africa) and aegeline. The version containing yohimbe, supplied to smaller health and supplement stores, is believed to have been brought in illegally by rogue importers.
The Centres for Disease Control and Prevention (CDC) in the US said that of the first 29 identified patients in Hawaii, 83% had used OxyElite Pro during the 60 days before the start of the illness. It has not yet been determined which versions were used.
No other dietary supplement or medication in common had been used by more than two patients, the CDC said, and common causes of the disease, including alcohol abuse and other chronic liver disorders, had been ruled out.
The cases occurred between May and October, the CDC said, and the patients ranged in age from 16 to 66. The most common symptoms were loss of appetite, light-coloured stools, dark urine and jaundice.
The capsules sell for between R500 and R700 for a bottle of 90.