News Release
MCC agrees Xenical safe for pharmacy
Recommendation deferred for assurances from pharmacists
Auckland, 24 June 2004 – The safety profile of weight loss medication Xenical® (orlistat) has been deemed suitable for
sale over the counter in New Zealand pharmacies by the Medicines Classification Committee (a Ministerial Advisory
Committee.
The MCC has however deferred a recommendation until their next meeting based on: the committee wishing to ensure that
measures to train pharmacists about the sale of Xenical are in place and, that the initial sale of Xenical would require
a face-to-face consultation.
“While we are very pleased with the committee’s positive findings that the safety profile of Xenical is suitable for
OTC sale as a restricted medicine, we are naturally disappointed in a deferral decision,” said Rob Mitchell, Managing
Director of Roche Products (New Zealand) Ltd. “We look forward to working with the pharmacy profession and Medsafe to
address these two remaining process issues.”
Reclassification to a Pharmacist Only Medicine will allow Xenical to be supplied under the advice of a pharmacist to
adults who are very overweight with a body mass index (BMI) of 30 or more. All sales of Pharmacist Only Medicines must
be recorded in a register or computer. The pharmacy profession welcome the increased professional responsibility.
“Pharmacists are often the first port of call for people with health issues or questions and are therefore in a key
position to help combat New Zealand’s alarming rise in obesity,” said Bernie McKone, President of the Pharmaceutical
Society of New Zealand. "We are developing a comprehensive weight management education programme for pharmacists to
ensure effective weight management counselling and better outcomes for people struggling to lose weight.”
Professor Jim Mann, Professor in Human Nutrition and Medicine at the University of Otago, supports the reclassification
of Xenical while noting that diet and exercise measures remain the cornerstone of treatment for obesity. “For New
Zealanders who are appreciably overweight or obese, especially those who have developed conditions associated with
obesity, it may be necessary to offer an approach which can complement lifestyle changes. The availability of Xenical
will provide such individuals with a clinically proven addition to the lifestyle changes that are essential to long term
weight control.”
Xenical customers are able to access the Xenical Support Programme which provides ongoing support and follow-up by New
Zealand registered dietitians. The Xenical Support Programme helps people learn to recognise the hidden fats in their
diet and encourages them to increase their physical activity. Adding Xenical is approximately 68% more effective in
helping people lose weight than diet alone.
ENDS