Warnings & Recalls for Prexige

Prexige Recall and FDA Denial

In November 2007, Prexige was removed from the UK and Canadian market after incidents of severe liver damage and hepatitis occurred in Australian patients receiving 200 mg to 400 mg per day. Prexige can lead to elevated liver enzymes four times as much as in any other NSAID.

Other warnings

Patients on Prexige should avoid drinking excess amounts of alcohol.Patients with a history of stomach or intestine problems, and liver, kidney and heart illnesses should consult with a doctor before taking Prexige. Patients on Prexige should be monitored closely for any sign of liver damage. If any of the following symptoms occur, the patient should consult a doctor immediately: unexplained itching, , yellowing of skin and eyes, dark urine, constant nausea and vomiting with abdominal pains and loss of appetite, and any flu-like symptoms.Prexige symptoms can be mask signs of an infection so patients should be checked regularly by their physician. People who should use Prexige with caution: the elderly, people with a history of stomach ulcers, smokers, people decreased liver and kidney function, and patients with liver cirrhosis. Also those who are at risk of dehydration, have a history of heart problems, suffer from hypertension, fluid retention, raised cholesterol levels, and diabetes should use Prexige with caution.Prexige should NOT be used in: children (18 years and younger), those with severe kidney and liver malfunction, those with past history of liver disease and raised liver enzymes, and those taking medications to correct these liver problems, those who are allergic to any other NSAID, and those with bowel diseases and current peptic ulcers. Also, those who are suffering from heart failure or heart disease with a history of heart attack, those with cerebrovascular disease and history of stroke, those with poor circulation in arteries, and patients with galactose intolerance should NOT use this medication.   Contraindications: Prexige should not used if the patient is allergic to any of its ingredients (microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 4000, povidone, talc, red iron oxide CI 77491, black iron oxide CI 77499, titanium dioxide, lactose and lumiracoxib). When used with a low-dose (75 mg max daily) aspirin, increased risk of ulcers and stomach bleeding may occur. Do not use with any other NSAIDs.  Contraindications include warfarin, antihypertensives, diuretics (Furosemide), ACE inhibitors (Enalapril, Captopril), angiotensin II antagonists (Losartan), Ciclosporin, Tacrolimus, Digoxin, Lithium and Phenytoin.   Family Planning: Do not use Prexige in the third trimester of pregnancy. When used this late in pregnancy, it may delay labour. It should only be used in the first and second trimester if the benefits to the mother outweigh the risks to the fetus. NSAIDs should also be avoided by women who are trying to becoming pregnant as it may increase miscarriage, malformations and infertility. It is not known whether Prexige will pass into the breast milk. Nursing women should be advised to not breast feed while on Prexige.

Other Names for Prexige

Brand Name:

• Prexige

Generic Name:

• lumiracoxib