No reports in Malta of adverse effects of fat-busting drug

The Maltese health authorities have not received any reports of adverse reactions from Alli, the non-prescription fat-busting drug that is under scrutiny in the US.

America's Food and Drug Ad-ministration is probing reports of liver damage in 32 patients taking Alli and its prescription version Xenical. A staggering 27 patients needed hospitalisation.

The Malta Medicines Authority's chief executive officer, Patricia Vella Bonanno said no reports had been received by the authority, which is responsible for medicines available in Malta.

GlaxoSmithKline's Alli was launched all over Europe in April after being approved by the European Medicines Authority (Emea). Alli, which had been available in the US since 2007, was the first over-the-counter weight-loss product to receive the approval of the European Medicines Agency and the FDA and proved popular with Maltese consumers who wanted to battle the bulge.

Roche's Xenical is double the dose of Alli.

The FDA announced last week it was reviewing safety information for the drugs following 32 reports of "serious liver injury", including six cases of liver failure. The US agency said the most commonly-reported problems were jaundice, weakness and hospitalisation pain.

The reports were made between 1999 and 2008 and most came from outside the US.

Monica Abdilla, from GSK's Malta branch and who is responsible for consumer health care, said there was no evidence that Alli caused liver damage. She said Alli was minimally absorbed in the blood and worked in the gastro-intestinal tract.

"There is therefore no obvious biological mechanism to suggest liver damage can occur with Alli," she said, adding that the safety of consumers was of utmost importance to GSK, which would continually monitor and evaluate reports of adverse effects associated with all products.

Ms Abdilla said people who were overweight and obese were predisposed to liver-related disorders. "The FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time," she noted.

In fact, the FDA said it had not established a direct relationship between the drugs and liver problems and was not advising health care professionals to change their prescribing practices.

"Consumers taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed," it said.

But it called on patients to consult their doctor if they experienced symptoms that could possibly be associated with liver problems, including weakness or fatigue, fever, jaundice or brown urine. Other symptoms could include abdominal pain, nausea, vomiting, light-coloured stools, itching or loss of appetite. It urged doctors and consumers to report side effects.

Information available on Emea's website points out that Alli "must not" be used by patients with a liver disorder.

Dr Vella Bonanno explained that Malta would file any adverse reaction reports directly to Emea, which would take decisions based on the whole European population.

She said that although over-the-counter drugs did not need a prescription, they were sold from pharmacies and patients could get the necessary advice from professional pharmacists.