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All about alliWeight-loss drug alli was launched in Ireland earlier this year and is sold without prescription inpharmacies. Consumer Choice questions the wisdom of this decision.
Earlier this year a licence was granted to with dieting, its side effects are milder and the package leaflet and the label will fat. Alli should only be used by adults of Medicines Agency’s (EMEA, see Useful supply of a centrally authorised medicine their customers fit these criteria. Alli costs AT A GLANCE
What is alli?
What is alli?
bought in a smaller dose. It should not be How alli works.
Consumer action.
HEALTH NOVEMBER 2009 consumer choice
We decided to visit a number of pharmacies in August and September ARE PHARMACIES FOLLOWING THE RULES?
2009 to determine whether pharmacists are sticking to the regulations LOCATION
CHECKED/
WILLING TO
ASKED BMI?
A press release announcing the launch of alli in pharmacies in Ireland in April 2009 stated the following: “Accompanied by an extensive pharmacy training and education programme, alli is being launched in pharmacies with full support to ensure that the pharmacy team is well equipped to advise on correct usage and help users achieve maximum benefit from the treatment. Alli therefore represents a real opportunity for overweight and obese people to benefit significantly from professional pharmacy intervention.” GSK also said at the time that it takes the need to market alli responsibly very seriously, and is training pharmacists to Ranelagh, Dublin 6
help them provide advice on weight loss, to ensure they recommend alli Inchicore, Dublin 8
to suitable patients only. GSK’s head of regulatory and external affairs Dundrum, Dublin 14
Niall O'Shea stated that "The pharmacies will check the individual is over Dundrum, Dublin 14
18, with a BMI of 28 or over, and will ask further questions." Drogheda, Co. Louth
Unfortunately our investigation found that this is not necessarily true in Naas, Co. Kildare
all cases, and in eight of the 20 pharmacies we visited, a pharmacist Naas, Co. Kildare
was found to be willing to sell alli to our researcher despite the fact that Portlaoise , Co. Laois
the researcher has a BMI of 19.1. This is contraindicated under the Limerick City Centre
requirement that users have a BMI of 28 or over before they are sold alli Limerick City Centre
Limerick City Centre
During the investigation we found some of the pharmacists were Limerick City Centre
deeply concerned that somebody with a BMI of under 28 was attempting Limerick City Centre
to purchase alli. They warned that it would be dangerous to take, and refused to sell it. However other pharmacists did not even question the request and one even asked if it worked effectively. It is worrying to see how lax pharmacists can be when it comes to advising customers about alli. Do our results, which show that a person with a BMI of 19 has almost a 50/50 chance of obtaining alli, mean that if someone has a BMI closer to 28 they have an even greater chance of obtaining the medicine? We believe there is a lot of room for improvement in this area. The responsibility has mainly been placed on pharmacists to regulate the sale of alli and therefore there should be stiff penalties for pharmacies that do not comply with the conditions of sale, such as checking the age of the customer and their BMI.
“the European Commission’s decision to approve alli for sale
over-the-counter is not in the best interests of consumers,
because the easy availability of the drug generates the
potential for abuse, particularly in vulnerable groups such
as teenagers and people with eating disorders”
in conjunction with a low-calorie, low-fat available in Ireland as a prescription-only with unpleasant side effects. There are no recent report in the Irish Times, the even if you take alli, you still have to eat up by GSK for its Irish customers, “When How does alli work?
of studies have evaluated the effectiveness additional 1lb.” The manufacturers also user absorbs. The fat does not get broken on its prescription-strength counterpart, Xenical.” Alli is not suitable for those instead. The tablets are meant to be used consumer choice NOVEMBER 2009 HEALTH
reports for orlistat, the prescription dose Useful contacts
of alli. The FDA releases a quarterly list of their appearance on the list "does not IMB Irish Medicines
relationship" with the drug. In August, pressure checks or tests for diabetes.
approve alli for sale over-the-counter is liver injury in patients taking orlistat. The Mayo Clinic
Side effects
because the easy availability of the drug described were jaundice (yellowing of the skin or whites of the eyes), weakness, and particularly in vulnerable groups such as with oily spotting. These side effects all doses of prescription Xenical. The two US highlighted the problem of alli being too limited by keeping to a low-fat diet. Alli patients were hospitalised, and six cases therefore does not get rid of existing fat; drug and have tried to fight against it. In resulted in liver failure. "The FDA's it just helps to stop additional fat from analysis of these data is ongoing, and no decided to give alli the temporary status definite association between liver injury and orlistat has been established at this and K by the body, so patients using alli moment it is not sold over the counter.
time," the agency said. It advised that fear of suffering the side effects may scare consult a doctor if they have symptoms of users into avoiding fatty foods altogether.
benefits. If a person doesn’t get enough use it or about the importance of changes investigation into the availability of alli available in pharmacies. The IMB said “All pains and depression (see ‘Essential Fats’, Consumer Choice, April 2008, p137). see the results on page 406, opposite.
disorders and are consistent with the type Consumer action
Orlistat probe
closely monitoring experience with use of Due to the EMEA’s decision, alli can be alli nationally”. It said it had no reports of Administration (FDA, see Useful contacts) a liver-related adverse reaction. Healthcare further need for authorisation at national listed alli among two dozen drugs that it level. The weight-loss aid is already being Report by
pharmacies in many European countries.
it was continuing to evaluate liver toxicity Sinéad Mc Mahon cc
number of internet sites. The CAI advises choice comment
Weight-loss drugs should not be available without a prescription and the advertising of alli should internet. The supply of prescription-only be curbed immediately. As our investigation shows, if users are not being monitored, it is too easy medicines via mail order is illegal.
for anybody who wants this medication to obtain it. This opens up the potential for abuse. Another concern is that people could take more than the recommended dosage of alli, making it the same strength as Xenical, which is a prescription-only drug. This could put the user’s life at risk or lead to serious health problems. Slimming pills should only ever be used with support and dietary advice because taking a pill does nothing to change the habits which may contribute to a person and their supply is not permitted, even if being overweight. Direct supervision by a healthcare professional would mean that patients’ they are non-prescription only products.
progress is monitored and the pills are not taken indefinitely. If you are concerned about your weight you should talk to your doctor who can take any other underlying health issues you may (IMB, see Useful contacts), up to 50% of have into account. A weight loss supplement should not be used to substitute a balanced diet and regular exercise – there is no quick-fix. HEALTH NOVEMBER 2009 consumer choice

Source: http://consumers.ie/pdf/ALLINov09.pdf