Arthritis drug pulled over health concerns

Source: Healthcare Exec

Date :21/11/2007 09:24:09

British drug regulators have suspended the licence of an arthritis drug amid concerns that it may cause liver damage, it emerged yesterday.

The Medicines and Healthcare products Regulatory Agency (MHRA) ordered Prexige, which has been available in the UK since December 2005, to be withdrawn from the market yesterday.

A spokesman for the MHRA said the decision had been taken after the Commission on Human Medicines reviewed the latest worldwide data on the safety of Prexige, which is also known as lumiracoxib.

Severe

"Importantly, the latest data shows an increase in the number of cases of serious liver reactions that have occurred with the licensed 100mg dose, and in some cases the reactions have been associated with short-term use," the spokesman said.

Prexige had previously been subjected to prescribing restrictions for patients with current or previous liver problems, and additional requirements for blood tests before and during treatment for other patients.

A spokeswoman for the Arthritis Research Campaign said the withdrawal of Prexige was a major blow for osteoarthritis sufferers and represented the "final nail in the coffin" for the class of drugs to which it belongs, COX-2 Inhibitors, or coxibs.

"This means there is even less choice available for people with osteoarthritis who are already struggling to find effective pain relief without unacceptable side effects," she said.

November 21, 2007