Diet Drug Xenical Closer To OTC Status In USA

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Main Category: Obesity / Weight Loss / Fitness
Article Date: 24 Jan 2006 - 15:00 PDT

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GlaxoSmithKline bought the US rights to Xenical from Roche a year ago. Xenical's low dose version is called Alli in the USA. The drug received an endorsement from the influential FDA Health Advisory Panel yesterday.

The FDA usually goes along with what the health advisory panel recommends.

If Alli becomes an OTC (Over the Counter) drug in the USA, the country's huge overweight population will be able to get it without first having to go and see a health care professional for a prescription.

(OTC = Over the Counter. This means you can get the drug without needing a prescription from a doctor)

This will be the first proven drug for losing weight to be sold as an OTC drug in the USA.

America has the highest number of overweight and/or obese people in the world - even when calculated as percentage of total population. Over 65% of the country's adult population is either obese or overweight.

The panel said that Alli is much safer than the present assortment of dietary supplements available in the USA today.

According to trials, when comparing Alli to a placebo over a six-month period, volunteers on Alli lost 4 to 5 pounds more.

Alli (orlistat) reduces the amount of fat the body absorbs. The drawback can be that your stools will be oily, you may experience rectal discharge - flatulence can be another side-effect. However, the less fat you eat, the less you will experience these side-effects. Basically, if you eat lots of fat while you are taking this drug, a lot of it will come out of the other end rather than being absorbed. It is important that the patient be on a low-fat diet when taking this drug.

As Alli has half the dose of prescription Xenical, GSK says the side effects will be much less.

Although we do not know when the Alli is likely to be approved (as an OTC drug), most people expect it to be on sale by the end of this year.

Whether or not this drug will become a blockbuster is anyone's guess. The side-effects are not dangerous, but they are very unpleasant and often embarrassing. So far, worldwide sales have been disappointing. Perhaps this lower dosage and its OTC status may boost sales.

At Medical News Today we have received many emails on this from doctors, nutritionists and consumers. The general message seems to be (for Xenical):

--'If you stick to a low fat diet it works really well.'

-- 'It cannot replace exercise and a good diet.'

-- 'I had to give up as my underwear was soiled all the time.'

-- 'It is the only thing that has worked for my very obese patients who did not want surgery.'

-- 'We have no idea what the side effects are after long term use of this drug.'

-- 'The drug forced me to avoid fatty foods if I wanted to keep my underwear clean. I lost a lot of weight.'

Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today