Novartis’ Anti-Arthritis Drug Lumiracoxib (Prexige), Recalled From Philippine Market

Here in the Philippines, the Bureau of Food and Drugs has ordered the pull-out from the market of the pain-killer anti-arthritis drug – Lumiracoxib (Prexige) by Novartis – due to fears that it can cause liver damage.

In November 2007, Novartis announced that Prexige had been suspended from sale and marketing in Britain and Germany amid fears it can cause liver damage.

Apparently, Austria, Australia and Canada have taken similar steps of pulling Prexige out of their markets. On the other hand, Prexige has not been approved for sale in the United States.

The health department’s Bureau of Food and Drugs ordered Novartis Healthcare Philippines Inc. to “immediately initiate a product recall and cease and desist from further importing, distributing, or selling Lumiracoxib (Prexige)” tablets.

A bureau advisory said it has “determined that the risks of Lumiracoxib-containing medicines are greater than their benefits,” citing “reports of cases from abroad concerning potential serious liver-related side effects.”

Lumiracoxib is an anti-inflammatory drug used for the treatment of the symptoms of osteoarthritis and dysmenorrhia. The drug is used as well as in dental and orthopaedic surgery.

Lumiracoxib (rINN) is a COX-2 selective inhibitor non-steroidal anti-inflammatory drug. Lumiracoxib has a different structure from the standard COX-2 inhibitors (e.g. celecoxib).

It more closely resembles the structure of diclofenac (one chlorine substituted by fluorine, the phenylacetic acid has another methyl group in meta position), making it a member of the arylalkanoic acid family of NSAIDs.

It binds to a different site on the COX-2 receptor than the standard COX-2 inhibitors. It displays extremely high COX-2 selectivity.

According to the Philippines’ BFAD:

“Patients who are using Lumiracoxib (Prexige) are advised to stop taking the drug and to immediately consult their physicians for information regarding their alternative treatments.

Novartis is in the process of recalling the drug from its distribution outlets
The bureau had no data on the number of people using the drug in the country and there were no reports of any patients showing the same symptoms as those reported in other countries.

Well, I guess it is about time that the Philippines followed suit in the market recall of this product.

Source: AFP Google