adverse effects of Lumiracoxib prexige(R)

Lumiracoxib: withdrawal because of severe liver injury in Australia / Germany: Limitations of Use
The Australian TGA and Drug Administration has ordered the withdrawal of lumiracoxib. The reasons for this decision by the TGA, was that there were five reported cases of liver failure associated with use of lumiracoxib and three more such cases from South America. In two cases, the liver injury was fatal, and in two other cases had a liver transplant. Lumiracoxib-containing medicines in Australia, with 100 mg and 200 mg of active ingredient per tablet for the symptomatic treatment of osteoarthritis (degenerative joint disease) or with 400 mg of active compound for the treatment of acute pain was admitted.

Lumiracoxib is a compound from the group of coxibs and is used for its anti-inflammatory and analgesic effect for the symptomatic treatment of osteoarthritis and acute pain. In the European Union including Germany lumiracoxib is also allowed, but only in one tablet strength and daily dose of 100 mg lumiracoxib and only for treatment of symptoms in osteoarthritis of the knee and hip joints, but due to adverse effects not for the treatment of other acute pain.

The newly reported cases of liver failure occurred almost exclusively on the application of the higher dose of lumiracoxib 200 mg and 400 mg per day. There are some adverse effects of lumiracoxib known. From the conducted prior to approval clinical trials showed that lumiracoxib may result in a dose-dependent increase in the activity of certain liver enzymes (transaminases) in the blood. This was one of the reasons for which high-dose lumiracoxib in the treatment of acute pain in the EU was not approved. Overall, before the BfArM few reports of liver dysfunction after lumiracoxib application, severe liver damage (liver failure) from Germany and the EU have not been previously reported.



The BfArM takes time along with the other drug regulatory authorities of the EU provide an evaluation of reports of hepatotoxic reactions to lumiracoxib application and the information about the side effects from clinical trials with lumiracoxib.

For the regulation and the use of lumiracoxib (Prexige ®), the already existing adverse effects (patients with severe liver dysfunction) and the product information contained in the warnings must be observed. Patients with symptoms that may be associated with liver damage (jaundice, nausea, itching, dark urine) occur, should ask their doctor for advice about further treatment. *** BfArM: "For the drug Prexige ® with the drug lumiracoxib in Germany and other EU countries applying restrictions under a" have Urgent variation "(urgent safety restriction, USR) set out the reason for these changes are a side effect reports of serious. liver damage that occurred, however, admitted primarily for higher doses than in the EU. With the changes to take control of liver enzymes before starting treatment prescribed with lumiracoxib and regular checks during treatment. In addition, lumiracoxib no longer be used in patients who are at increased risk have liver damage. lumiracoxib is a compound from the group of coxibs and is used for its anti-inflammatory and analgesic effect for the symptomatic treatment of osteoarthritis and acute pain. In the European Union including Germany lumiracoxib is also allowed, but only in one tablet strength and daily dose of lumiracoxib 100 mg and only for treatment of symptoms in osteoarthritis of the knee and hip joints, but not for the treatment of other acute pain.