HSA Alerts Public to “OxyELITE Pro” – an Unregistered Medicinal Product Linked to Serious Liver Injuries

The Health Sciences Authority (HSA) is alerting members of the public to an unregistered medicinal product labelled as “OxyELITE Pro”, which has been linked to numerous cases of serious liver injuries in the United States (US) and one case in Hong Kong. “OxyELITE Pro” is a medicinal product not approved for sale by HSA. However, investigations by HSA have found that the product is being sold illegally through the Internet in Singapore and some members of the public may have purchased the product from overseas.

More about “OxyELITE Pro”

2      “OxyELITE Pro” is marketed overseas as a dietary supplement and as a fat burner to achieve rapid weight loss. It is labelled to contain herbal extracts. Preliminary laboratory tests conducted by HSA on the “OxyELITE Pro” capsules bought from an Internet seller have found the product to contain 1,3-dimethylamylamine (DMAA) and yohimbine which are potent western medicinal ingredients that are not allowed to be present in supplements sold locally. Health products containing such ingredients require registration as medicinal products and can cause serious adverse effects when consumed without medical supervision. Investigations are ongoing to detect other potentially undeclared ingredients which may have caused the liver injuries.See Annex A of the downloadable pdf for photos of the seized product.

Cases of acute hepatitis in the US

3      The US Food and Drug Administration (FDA) has recently reported 29 cases of acute non-viral hepatitis (liver injury) in the state of Hawaii. Although the actual cause of the liver injuries has not been identified, investigations have found that 24 of these cases were associated with the use of the medicinal product “OxyELITE Pro”. Eleven of the 29 cases have been hospitalised with acute liver injury: two of these cases have resulted in liver transplants and one person has died as a result of the complication of the serious liver injuries. The most commonly reported symptoms of liver injuries experienced by the patients include loss of appetite, jaundice, dark urine and light-coloured stools.

4      The US Centers for Disease Control and Prevention (CDC) is currently investigating other cases of liver injury in other US states that may be related to these events in Hawaii. The US FDA is also investigating the contents of the product “OxyELITE Pro”, and its manufacturing premises, as well as whether counterfeit products or any other ingredients could be related to these cases of acute liver injuries.

5      To date, HSA has not received any adverse reaction reports associated with the use of “OxyELITE Pro” although it could be possible that consumers who have suffered side effects may not have told their doctors or pharmacists about the use of this product. See Annex B of the downloadable pdf for the possible adverse effects of yohimbine and DMAA which include increased blood pressure, irregular or rapid heartbeats and chest pain. HSA is in contact with the overseas counterparts on their on-going investigations.

Public advisory

6      In view of the seriousness of the liver injuries possibly related to “OxyELITE Pro”, HSA strongly advises members of the public who are taking this product to stop consuming it immediately. As a range of products is available under the brand name of “OxyELITE Pro”, it cannot be confirmed which specific formulation may be responsible for the liver injuries. As a precautionary measure, consumers are advised to stop taking this range of products labelled “OxyELITE Pro”. Members of the public are also advised to consult a doctor as soon as possible if they are feeling unwell after taking “OxyELITE Pro”.

7      Members of the public who have any information on the sale of this unregistered medicinal product may contact HSA's Enforcement Branch at Tel: 6866-3485 during office hours (Monday to Friday) or email: hsa_is@hsa.gov.sg. Additionally, members of the public are encouraged to visit www.healthdangers.sg to learn more about the dangers of buying illegal health products from dubious sources.

Warning and advice to sellers

8      HSA warns sellers to stop the sales and distribution of “OxyELITE Pro” as this is an unregistered medicinal product. Anyone selling such products will face a penalty fine of up to $10,000 and/or imprisonment for a period of up to two years under the Poisons Act.

HEALTH SCIENCES AUTHORITY
18 OCTOBER 2013

Download pdf version here276 KB

Published: 18 Oct 2013

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