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 levelsĀ of testosteroneĀ in the end productĀ wereĀ confirmed to beĀ 400-700 pg/ml, which isĀ less thanĀ one millionth ofĀ theĀ internationally acceptedĀ standardĀ for impuritiesĀ (1 picogramĀ being equal to one billionth of a milligram).
Nick Bova, managing Director of Bova UK, said: āWe have consultedĀ veterinary pharmacologistsĀ and sports medicine specialistsĀ whoĀ haveĀ given their opinion thatĀ these levels areĀ within acceptedĀ standards andĀ could neither have aĀ clinicalĀ effect norĀ result inĀ a positive blood or urine test for testosteroneĀ in competition horses.
āThe levelsĀ of testosterone within the product are inconsequential compared to endogenous production in maresĀ and geldings as well as stallionsĀ and higher levels are found frequently inĀ feed and water sources; testosterone being a common compound produced byĀ humans and animals from multiple organs.ā
The source of the contamination was traced to the excipient used in the product, which was used byĀ Bova Aus and Bova UK.Ā 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: āWhilst we hope to reassure you that the use of long acting injectable omeprazole will notĀ haveĀ hadĀ adverseĀ implications for your patients or clients weĀ can also reassure you that we are notĀ complacent about the presence ofĀ impurities in any of our products, particularly an impurity that is of such significance to equestrian sport.
āAlthough the level of impurities is well within the accepted international standard, we haveĀ 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.
āWeĀ sincerely apologise for any inconvenience thisĀ issue may have caused. Many vets and horse owners now rely on long acting injectable omeprazole for horses that do not respondĀ 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.
āHowever, 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.ā
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