A pharmacy handout promoting companion sales of statins with coenzyme Q10 supplements has been ordered to be withdrawn due to 'misleading claims.'
The Complementary Healthcare Council of Australia Complaints Resolution Committee (CRC) made the decision, after a complaint was lodged arguing that the handout for CoQ10 Excel 150 mg breached the Therapeutic Goods Advertising Code.
Dr Ken Harvey, from La Trobe University, made the complaint after a pharmacy assistant in Melbourne recommended co-enzyme Q10 should be purchased with his wife’s repeat statin script.
The assistant provided a ‘Statin prescription and coenzyme Q10’ handout claiming “Statins are very effective at reducing cholesterol levels in the blood, however, they can also decrease the body’s supply of Co-enzyme Q10 (CoQ10).”
Dr Harvey said the claim: “This leads to side effects such as sore muscles and lack of energy” was incorrect, unbalanced and misleading because it failed to indicate that sore muscles were an uncommon side-effect of statins.
“To my knowledge ‘lack of energy,’ while a common complaint, has not been specifically associated with statin use,” he said.
“Furthermore, the overall message of the handout , reinforced by the sales spiel, is that all patients prescribed a statin need a ‘companion sale’ of CoQ10 to prevent side-effects.”
This was not in accord with NPS advice noting that no trials had shown taking coenzyme Q10 supplements with a statin prevented myalgia, he said.
On 23 August, the CRC found the handout breached clauses of the Therapeutic Goods Advertising Code 2007:
4(1)(b) contain correct and balanced statements only and claims which the sponsor has already verified.
4(2)(a) be likely to arouse unwarranted and unrealistic expectations of product effectiveness.
4(2)(c) mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions.
4(2)(d) abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or distress.
The CRC has requested any remaining copies of the material be destroyed, and the sponsor, BioCeuticals, has advised that any future materials will be modified to ensure regulatory compliance.
In response, Evan Hayes, chief scientific officer, BioCeuticals, said the material was based on published scientific literature supporting the use of coenzyme Q10 with statin therapy.
"However, we understand that the recommendation of certain nutritional supplements with prescription medicines has been contentious from a regulatory perspective and so, at the time, BioCeuticals voluntarily withdrew the handouts from the market," he said.