After the Federal Food and Drug Administration said that they were looking into reports earlier this year that orlistat could be linked to liver problems, they have now said that they are investigating 32 cases of liver damage.
Orlistat is sold in two forms, as the over-the-counter pill Alli or in a stronger-dose, prescription-only version Xenical. Xenical has been available in the UK for ten years and generally it has been considered a safe medication, though some patients have reported unpleasant side effects such as extreme flatulence.
When Alli, manufactured by GlaxoSmithKline, went over the counter, the medication received a great deal of attention from the media. It has proved to be a massive seller for the drugs company; since it hit the pharmacies in April, 200,000 people have bought the product.
The FDA said that they are looking into 32 reports of liver problems received between 1999 and 2008, nearly all of which occurred outside the U.S. Of those who fell ill, 27 of them required hospitalisation.
Compared with the number of people taking the medicine worldwide, the number of reports is extremely small and experts have said that those who are obese are at greater risk of liver damage in any case.
The FDA have said that patients should continue taking the medication as normal while the European Medicines Agency have said that they have no current plans to change the product information, though this is being reviewed.
GlaxoSmithKline responded to the inquiry by citing patient safety as their top priority and promised that reports of side effects were carefully monitored. They reminded patients that Orlistat had had extensive clinical trials and said that as orlistat is a non-systemically acting drug, minimally absorbed into the blood, there was no ‘obvious biological mechanism’ to suggest it was associated with liver damage.