Britain and Germany have suspended the sale and marketing of the anti-inflammatory painkiller drug Prexige. Manufactured by the Swiss pharmaceutical giant Novartis,the suspension comes amid fears that the drug may cause liver damage.
Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) said in a statement it was suspending the license of Prexige "due to the safety concerns about possible liver damage for patients."
Germany and Austria have also taken similar steps, following suspensions earlier this year in Canada and Australia, Novartis said.
The US regulator did not approve Prexige for sale or marketing at the end of September -- the second time that Novartis had sought to launch what it hoped would be a "blockbuster" drug in the country.
"Patients taking Prexige in the UK, Germany and Austria should consult their healthcare provider," the company advised.
"Other EU countries may decide to independently suspend the marketing authorisation or sale of Prexige ahead of a decision" by the EU's medical regulator expected in December, it added.
The company said that "available data suggest that Prexige 100 mg once-daily for osteoarthritis is not associated with increased hepatic (or liver) risk" compared to other painkillers.