There has been concern in the pharmaceutical world after the U.S drugs regulator the FDA announced that it was investigating reports that the weight loss drug orlistat was linked to a series of cases of liver damage.
Orlistat is the medical name for the diet pills Alli, which is sold over the counter worldwide. In the UK it went on sale in April and since then GlaxoSmithKline, who manufacture it, have seen over 200,000 people try the product.
Alli are the first diet pills with a clinically trialled drug as the active ingredient to be approved by the FDA for sales over the counter, which happened in 2007.
It is also the ingredient in the prescription-only slimming tablet Xenical , a higher-dose version of Alli. Xenical has been available for the past 10 years and is often prescribed by GPs to help severely overweight patients to reach their target body mass index (BMI).
The FDA said the most commonly reported side effects was yellowing of the whites of the eyes or of the skin, stomach pains or weakness. There were 32 reports of liver damage, 30 of which came from outside the U.S. 27 of those people required treatment in hospital.
Orlistat promotes weight loss by stopping the absorption of dietary fats into the blood stream, by blocking the action of an enzyme in the gastro-intestinal tract. It is only available to people who are considered clinically obese, usually measured by their BMI. Clinical trials suggest that when it is combined with a low-calorie diet and exercise users can lose up to 50% more of their body fat than through diet and exercise alone.
GlaxoSmithKline have issued a statement saying that they do not believe that Alli is causing liver problems. They said, “Alli is a 'non-systemically' acting medicine - it is minimally absorbed in the blood and works locally in the gastro-intestinal tract. There is therefore no obvious biological mechanism to suggest liver damage can occur with Alli.”
Their spokesperson Debbie Bolding, also added that “people who are overweight and obese are pre-disposed to liver-related disorders.”
The FDA have recommended that patients taking the diet pills Xenical and Alli continue to use them as normal and their spokesperson advised that “No definite association between liver injury and orlistat has been established.”
By Glean Richard Prof.
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