omeprazole Following the identification of testosterone in a vial of Bova’s long acting omeprazole injection for horses in mid-June 2019 by the New South Wales (NSW) racing authority, Bova says subsequent tests have now confirmed that the level of contamination was less than one millionth of the internationally accepted standard for impurities, well below the level that could have resulted in a positive drug test.
After the contamination was first identified, sales of the product in Australia were stopped immediately and Bova initiated an investigation.
The British Horseracing Authority then conducted its own analysis of samples of the UK product, discovering that it too was contaminated with testosterone.
However, Bova says the levels of testosterone in the end product were confirmed to be 400-700 pg/ml, which is less than one millionth of the internationally accepted standard for impurities (1 picogram being equal to one billionth of a milligram).
Nick Bova, managing Director of Bova UK, said: “We have consulted veterinary pharmacologists and sports medicine specialists who have given their opinion that these levels are within accepted standards and could neither have a clinical effect nor result in a positive blood or urine test for testosterone in competition horses.
“The levels of testosterone within the product are inconsequential compared to endogenous production in mares and geldings as well as stallions and higher levels are found frequently in feed and water sources; testosterone being a common compound produced by humans and animals from multiple organs.”
The source of the contamination was traced to the excipient used in the product, which was used by Bova Aus and Bova UK. Both companies have now switched their supplier of this excipient. Bova says all testing done on the new supplier has shown no traces of testosterone, even with the new extra sensitive method of analysis which is capable of reaching picogram levels.
Nick added: “Whilst we hope to reassure you that the use of long acting injectable omeprazole will not have had adverse implications for your patients or clients we can also reassure you that we are not complacent about the presence of impurities in any of our products, particularly an impurity that is of such significance to equestrian sport.
“Although the level of impurities is well within the accepted international standard, we have changed the supplier of the excipient in question. We have established an analytical method capable of testing down to picogram levels, which has been used to test the end product to ensure there are no further concerns with future batches.
“We sincerely apologise for any inconvenience this issue may have caused. Many vets and horse owners now rely on long acting injectable omeprazole for horses that do not respond to oral treatment and we can reassure anyone who has used the product in recent months, or has product that they are due to use, that they can do so safely.
“However, we would draw attention to the recent statement from the BHA that they do not wish the product to be used in horses in training currently.”