Side effects: Novarits not to market Prexige

Novartis has dropped plans to market its new pain relief drug, Prexige (lumiracoxib) in India due to the growing concerns about its adverse side effects among the drug regulatory authorities in key developed nations.

Novartis had received the mandatory approvals from the Drugs Controller General of India (DCGI) in February 2007 to import and market Prexige.

"We have no plans of launching Prexige in India," a Novartis India spokesperson said.

The recent setback for Prexige came from the European Medicines Agency, which felt the need for a review of its safety profile.

The medicine was withdrawn from the Australian market a few months ago on complaints of adverse side effects. The United States Food and Drugs Administration (USFDA) has not approved the medicine, either.

Prexige belongs to the class of 'cox-2 inhibitors', which have been found to have serious side effects. India is among the countries that banned the use of "cox-2" medicines such as Roficoxib and Valdecoxib due to reported adverse drug reactions.

While India had banned Roficoxib on December 13, 2004, Valdicoxib and its formulations were banned on July 25, 2005. The Indian decision was influenced by the adverse drug reactions reported in foreign countries.

Medical experts feel that all medicines belonging to the "cox-2" class are likely to have similar side effects and may have to be phased out soon.

The National Pharmacovigilance Advisory Committee, the apex drug adverse reaction monitoring body in the country, placed "cox-2" medicines under the scanner a year ago.