Patrick
In the interest of public health and safety, the Department of Health – Bureau of Food and Drugs announces that it had directed Novartis Healthcare Phils. Inc. (Novartis) to immediately recall from the Philippine market its LUMIRACOXIB (PREXIGE) 100mg, 200mg and 400mg Tablet, a COX-2 selective inhibitor, non-steroidal, anti-inflammatory drug. The above product was registered for the symptomatic relief in the treatment of osteoarthritis; for the short-term relief of moderate to severe acute pain associated with primary dysmenorrhea, dental surgery and orthopaedic surgery.
The Department of Health – Bureau of Food and Drugs, following reports of cases from abroad concerning potential serious liver-related side effects associated with the use of the aforementioned drug, determined that the risks of lumiracoxib-containing medicines are greater than their benefits. Hence, it issued a Product Recall Order enjoining Novartis to immediately initiate a product recall and cease and desist from further importing, distributing or selling LUMIRACOXIB (PREXIGE) 100mg, 200mg and 400mg Tablet.
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.
Source: DOH-BFAD Advisory 2008-001 dated 09 January 2008.
Other information about LUMIRACOXIB:
On September 27, 2007, the US Food and Drug Administration issued a not approvable letter for lumiracoxib, requiring additional safety data.
On August 11, 2007, Australia’s Therapeutic Goods Administration (TGA, the Australian equivalent of the FDA) cancelled the registration of lumiracoxib in Australia due to concerns that it may cause liver failure.
New Zealand has followed suit with Australia in recalling Prexige.[5]
On October 3, 2007, Health Canada requested sales of Prexige to stop. Novartis has agreed to the request and has taken steps to do so.
On December 13, 2007, the European Medicines Agency recommended the withdrawal for Prexige from all EU markets[7].
On January 17, 2008, the Philippines’ Department of Health ordered Novartis Healthcare Phils. Inc. (Novartis) to remove (recall) all lumiracoxib from local drug stores in 2 weeks due to the harmful effects of the drug (potential serious liver-related side effects, hepatoxicity or malfunction of the lungs).
