Xenical

CHOICE is concerned the weight loss drug is being sold inappropriately.
 
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  • Updated:14 Feb 2007
 

01 .Introduction

Xenical

Update February 23, 2007: Xenical advertising banned by regulatory agency

The National Drugs and Poisons Scheduling Committee has withdrawn permission for Xenical to be advertised directly to consumers. However, it did not change Xenical's status to a S3 'pharmacist only' drug. CHOICE argues that Xenical needs to be dispensed by doctors to ensure that consumers are not paying for a product that won't work for them.

Please note: this information was current as of February 2007 but is still a useful guide to today's market.


In their decision the NDPSC "noted the advice from professionals and consumers that direct-to-consumer advertising increased pressure on pharmacists to provide orlistat to consumers. This in turn had the potential to result in inappropriate patterns of use, in patients for whom orlistat was neither indicated nor appropriate."

Xenical (also known as orlistat) is a drug that's promoted as a treatment for overweight and obesity. It can help you lose weight, but it's only suitable for people who are obese with a body mass index (BMI) of 30 or more, or with a BMI of 27 or more with obesity-related risk factors such as high blood pressure or cholesterol. It can also have unpleasant side effects if not used correctly (see Xenical: Q&A).

What's the problem?

Originally when it went on sale in Australia Xenical was a schedule 4 (S4, 'prescription only') drug. But in October 2003 it was granted schedule 3 (S3, 'pharmacist only') status, which doesn't require a prescription. And subsequently in June 2006 the pharmaceutical company, Roche, was given permission to advertise the drug to consumers using its brand name (Xenical).

When its recent advertising stint during TV shows including Australian Idol put Xenical into the mainstream, we were concerned that the audience -- with a high proportion of young female viewers -- could be left with the impression that the drug was a quick-fix solution suitable for anyone who wants to lose weight. We also heard of anecdotal evidence that there had been a noticeable increase in the number of people in the healthy weight range requesting Xenical coinciding with the onset of branded advertising for the drug.

Xenical has an important place in helping people who are obese or who are overweight with obesity-related health problems. But Choice is concerned that its S3 status means that Xenical is too easily accessed by people who shouldn't be taking it, and that there's potential detriment to consumers if it's marketed inappropriately.

The Pharmaceutical Society of Australia (PSA) has issued guidelines for pharmacists to follow when supplying Xenical. In summary, pharmacists should:

  • Assess whether or not Xenical is appropriate for the patient.
  • If supplied, provide counselling on points including dosage, side effects and lifestyle modifications required.

In theory, if the guidelines are followed only eligible people should receive the drug and they'd receive appropriate advice and counselling. We sent a researcher to pharmacies across the Sydney metropolitan area to see what happens in practice.

 
 

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02.Choice shadow shop

 

What we did

A shadow shopper visited 30 different pharmacies in the Sydney metropolitan area over four days in December 2006 and asked to purchase Xenical.
Upon leaving each pharmacy, she immediately wrote down the details of the transaction.

Our shadow shopper

Age: a young-looking 19-year-old female
Height: 168cm
Weight: 70kg
BMI: 24.8
Diet: healthy diet of meat, fruit and vegetables, rarely eats takeaway food
Exercise: walks three to four hours a week and swims regularly
Occupation: full-time student, employed part-time as a lifeguard at a swimming centre
Health: no obesity co-morbidities (such as diabetes, high blood pressure etc.)
Xenical suitability?: Xenical isn't appropriate for her, according to PSA guidelines.

What we found

Our shadow shopper was sold Xenical in 24 (80%) of the 30 pharmacies visited. This clearly demonstrates that many pharmacists aren't following PSA guidelines (see below) and are supplying the drug inappropriately. Here are the details:

Assessment

  • Less than one third of the pharmacies measured or asked for her height and weight. These details are needed to calculate BMI, which should be considered before supplying Xenical.
  • Her BMI was calculated in just nine pharmacies (in one of these she had to do the calculation herself). Three of these pharmacies went on to sell her Xenical.
  • Two correctly calculated her BMI as 25 but sold Xenical to her anyway. The third incorrectly calculated her BMI as 27 (using her height and weight measurements, which she gave them) and sold her the drug.
  • No-one measured or asked for her waist circumference. The PSA guidelines suggest considering this, along with BMI, before supplying Xenical. (A waist circumference of ¡Ý 102cm in men and ¡Ý 88cm in women is associated with a substantially increased disease risk due to obesity and overweight in adults).
  • No-one confirmed our researcher's age (even though the safety and effectiveness of Xenical in children hasn't been established, so it's not recommended to children or adolescents under 18 years of age).

Counselling

In the 24 pharmacies where she was sold Xenical:

  • Eight gave no directions on how to use the product, and of the 16 who did the explanations were brief.
  • Only 13 gave her some counseling or advice about diet and exercise when taking the drug.
  • Side-effects of Xenical were mentioned in just 16 pharmacies.

Retail environment

  • In our shadow shop, the average consultation time was just 6.2 minutes, which sometimes included waiting time. The busy retail environment may be the reason why the pharmacy didn't always undertake a proper consultation.
    "She handed me the product, didn't say anything to me at all, only told me the price."
    "No info. was exchanged at all, he told me the price of the product and gave it to me."
  • 'Ensure consultation is private' is one of the PSA guidelines. But none of our shadow shopper's consultations were conducted in a private area (although on one occasion she was taken to a slightly less busy part of the counter).

Inappropriate supplying

Our research revealed that many pharmacies sold Xenical to our shadow shopper even though she didn't meet the criteria for the drug.

  • On several occasions the pharmacy commented to our shadow shopper that she didn't need Xenical, but sold it to her regardless:
    "He said that I didn't really look like I needed to lose weight, so I could probably use it for around two months."
    "She told me that although she doubted I was obese that it's good to set a target weight goal to aim for."
    "He told me that I didn't really look overweight, though it would help me to lose a few kilos."

Price

  • Xenical isn't a cheap drug, and pharmacists have the opportunity to further mark-up the retail price. In our shadow shop, the price of a two-week pack of Xenical varied between $59.95 and $79.95, with an average price of $67.89.

Choice verdict

CHOICE is concerned that Xenical is being supplied inappropriately, and that advertising Xenical direct to consumers is sending the wrong message about weight loss to the Australian public and could encourage excessive use.

We're campaigning for:

  • advertising approval for Xenical to be removed
  • Xenical's schedule to be changed back to S4 (requiring a prescription)

For details of our campaign, and what you can do to help, see Drug advertising: TAKE ACTION.

PSA Guidelines

Xenical is available from pharmacies without a prescription. But the PSA has developed guidelines for pharmacists to follow when supplying it. These include:

Assessment

Before Xenical can be sold, pharmacists are supposed to clarify the patient's needs and confirm that Xenical is appropriate. Amongst other things, they're expected to:

  • ensure the consultation is private
  • consider BMI and waist circumference
  • consider health status (existence of conditions such as diabetes or high blood pressure, for example)
  • consider age

Counselling

If Xenical is supplied, pharmacists should then give counselling on points including:

  • action and dosage
  • drug interactions
  • side effects
  • lifestyle modifications (including diet and exercise).

Xenical is not the magic bullet solution to obesity. CHOICE is concerned that advertising Xenical direct to consumers is sending an inappropriate message to the Australian public. See Drug advertising: TAKE ACTION, below for details.

What is it, and how does it work?

Xenical (also known as orlistat) is a drug that's promoted as a treatment for overweight and obesity. It works in your stomach and intestine by preventing your body from absorbing as much as 30% of the fat you eat. As a result it can help you lose weight. But it's only suitable for some people. See Who can use it?

You need to take Xenical when you're eating the fat in your diet, so you will usually take a capsule with each of the three main meals a day. Your daily intake of fat, carbohydrate and protein should be distributed over these meals.

  • Xenical only works in the presence of dietary fat in your body, so if you miss a main meal or if you know the meal contains no fat, then you don't need to take it.
  • But you also need to limit the fat that you do eat to less than 12g in each meal and no more than 40g of fat per day. A really fatty meal could result in some unpleasant side effects.

Is it effective?

A clinical trial has found that participants who took Xenical three times a day lost an average of 4.8kg in the first month, increasing up to 7.2kg at 3 months. After a year, the average loss was 10% of original body weight.

Xenical has also been studied for long-term weight loss (up to 4 years).

IMPORTANT: weight loss occurs with Xenical when used in conjunction with a reduced fat diet and exercise program.

What are possible risks and side effects?

Because you don't absorb all the fat you eat when taking Xenical, the most common side effects are gastro-intestinal problems, including:

  • oily bowel movements
  • frequent bowel motions and flatulence
  • diarrhoea
  • abdominal pain

Xenicalalso affects the amount of fat-soluble vitamins and beta-carotene you absorb, so a vitamin supplement taken at least two hours before or after taking Xenical may be recommended.

Who can use it?

You're only eligible to receive Xenical If you have:

  • a BMI (Body Mass Index) of 30 and over; OR
  • a BMI of 27 and over with other risk factors like diabetes or high blood pressure

Studies haven't been done in children or teenagers under 18 years or adults over 74 years of age, so it's not recommended for these groups.

How do you get it?

Xenical is available from pharmacies. You don't need a prescription, but before it can be sold pharmacists are supposed to assess you for suitability. They're expected to check:

  • weight, height and BMI
  • health status (existence of conditions such as diabetes, high blood pressure, ostesoporosis, for example)
  • age
  • factors contributing to excess weight (including genetic influences, life states and events, and medical conditions or treatments).

If Xenical is dispensed, pharmacists should then give counselling on points including dosage, side effects and lifestyle modifications required (including diet and exercise).
Cost: Approximately $128 for one month's supply.

IMPORTANT: it’s always sensible to be fully checked out by your doctor before trying any medication – they’re the best person to advise you on your situation and help you decide on the best and safest way to tackle your problem.

Drug advertising: TAKE ACTION

Since September 2006, Roche (the manufacturer or Xenical) has been allowed to advertise directly to consumers – you may have seen the ads on TV.

CHOICE is concerned because:

  • The ad suggests that Xenical could be appropriate for anyone who thinks they have a weight problem. But only certain people are eligible.
  • It doesn't make it clear that changes to diet and exercise are essential to weight loss.

CHOICE has complained about the advertisements to the regulator. We've also written to the National Drugs and Poisons Schedule Committee asking that advertising approval for Xenical be removed and for this drug's schedule to be changed back to S4 (requiring a prescription).

If you'd like to support our actions, or for more information, go to Drug Advertising.