US liver safety probe for OTC weight loss drug
By Nigel Praities
Regulatory authorities in the United States have ordered a review of the safety of orlistat after reports of serious liver injury in patients taking the drug.
Just months after orlistat was licensed for over the counter use in the UK, the Food and Drug Administration in the US has announced a major review of its safety data following reports of liver damage.
The review comes after 32 cases of serious liver injury in patients taking orlistat were reported to the FDA between January 1999 and October 2008, including six cases of liver failure.
Leading GPs warned of increasing side-effects associated with orlistat when the drug went on sale in pharmacies this April, with RCGP chair Professor Steve Field saying people shouldn't think ‘a pill is the answer' to losing weight.
The UK medicines regulator said it was aware of the FDA investigation and was ‘closely monitoring' both the prescription and OTC versions of orlistat.
The Medicines and Healthcare products Regulatory Agency said it had received a total of 137 suspected hepatic adverse drug reactions since orlistat was licensed in 1998.
These figures include two cases where a patient died and single case of a abnormal liver function test in a patient taking OTC orlistat or alli.
A spokesperson said: ‘The MHRA is continuing to closely monitor the safety of all medicinal products including alli and Xenical.'
A spokesperson from GSK said there was no evidence orlistat causes liver damage and they were continuing to work closely with regulatory authorities.
‘Any routine assessment from a regulatory body does not mean that a risk or causal relationship exists,' she said.The Food and Drug Administration in the US has ordered a review of the safety of orlistat after reports of serious liver injury in patients taking the drug. The Food and Drug Administration in the US has ordered a review of the safety of orlistat after reports of serious liver injury in patients taking the drug.