THE EUROPEAN Medicines Agency has recommended the product information for the widely used weight-loss drug Alli be updated after kidney and pancreatic problems were reported in a number of patients using the drug.
In its latest monthly report, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) said that it had recommended changes to the usage guidelines following an assessment of the “adverse events” associated with the drug.
The CHMP has requested European Commission approval for the drug’s licensing information to include a warning that patients taking medicines such as the hormone replacement levothyroxine, and anti-epileptic drugs or patients with kidney disease should consult a doctor before using the drug.
It has agreed with the drug’s manufacturer GlaxoSmithKline that updated information, relating to the renal and pancreatic risks associated with the drug, be communicated to pharmaceutical associations, on receipt of EC approval.
Alli, also known as Orlistat, became the first weight-loss drug approved by the Food and Drugs Administration in the US to be sold over the counter in 2007. It was licensed as a non-prescription drug by the European Commission earlier this year, and went on sale in Ireland in April.
GlaxoSmithKline estimates that up to 50,000 people in Ireland have already “trialled” alli since its launch here.
The drug works by absorbing fat from food and preventing it from being retained as extra weight.
Orlistat, under the trade name Xenical, has been available in Ireland at a higher dose as a prescription-only medicine since 1998.
The Irish Medicines Board confirmed yesterday it was aware of the CHMP’s recommendation in relation to Alli.
A spokeswoman said the licensing information for the prescription drug Xenical does list renal and urinary tract infections as potential side effects, and the recommendation in relation to Alli appeared to be an attempt to bring the drug in line with its prescription-only counterpart Xenical.
The EMEA launched an investigation into the drug’s potential links to liver damage in July after concerns were raised about potentially harmful side effects. However, it concluded that there was no need to update the European Union product information on Orlistat-containing medicines as it already included a risk warning associated with liver-related problems.
The Irish Medicines Board had received six reports of adverse reactions associated with Alli as of August last, all of which related to gastro-intestinal disorders, but it had no reports of liver or kidney-related adverse reactions.
GlaxoSmithKline Ireland confirmed yesterday that changes to the product information for Alli had been made at the request of the CHMP.
The company’s head of regulatory and external affairs, Niall O’Shea, said: “These changes align the product information for Alli with that of the prescription product, Xenical.”
Mr O’Shea said: “Consumers can be reassured that Orlistat, the active ingredient in Alli, is the most studied weight-loss medicine, with a safety profile established through 100 clinical studies involving more than 30 thousand patients.”
