Removal of Celebrex (celecoxib) Boxed Warning and other important changes to the PI

Pfizer Australia is pleased to announce that, after a detailed review of the current Celebrex data, the TGA has reached an agreement with Pfizer Australia to remove the Boxed Warning and to significantly change the restrictive PI wording that was imposed on Celebrex in February 2005.

The revised PI now more appropriately reflects the body of evidence on cardiovascular safety at the doses of Celebrex recommended for the treatment of osteoarthritis (OA) and rheumatoid arthritis (RA). The main changes to the PI are:- Removal of the Boxed Warning- The restriction to Celebrex being used only after other therapies have failed has been removed- Updates reflecting the most recent evidence have been made to the Contraindications, Precautions, Dosage and Administration and Clinical Trials sections of the PICONTRAINDICATIONS: The contraindication in patients at high risk of cardiovascular disease has been replaced with 2 contraindications, which are more specific and helpful to prescribers:- CELEBREX is contraindicated for the peri-operative treatment of pain in patients undergoing coronary artery bypass graft (CABG) surgery (see PRECAUTIONS).- CELEBREX is contraindicated in patients with unstable or significant established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease (see PRECAUTIONS).PRECAUTIONS: The Precautions section now reads:The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks and benefits of therapy (see CONTRAINDICATIONS & PRECAUTIONS).Cardiovascular Adverse EffectsCOX-2 inhibitors have been associated with an increased risk of cardiovascular and thrombotic adverse events.Celecoxib is a COX-2 inhibitor (see CLINICAL TRIALS, Cardiovascular Safety).All NSAIDs, both COX-2 selective and non-selective may cause an increased risk of serious cardiovascular thrombotic events. This risk may increase with duration of use.Patients with known cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.CELEBREX should be used with caution in patients at high risk of cardiovascular disease including those with significant and multiple risk factors (e.g. diabetes, hypertension, hypercholesterolemia, cardiac failure and smokers).To minimize the potential risk for an adverse cardiovascular event in patients treated with celecoxib, the lowest effective dose should be used for the shortest duration possible – (see CLINICAL TRIALS, Cardiovascular Safety and DOSAGE & ADMINISTRATION).Physicians and patients should remain alert for such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the signs and/or symptoms of serious cardiovascular toxicity and the steps to take if they occur.DOSAGE & ADMINISTRATION: The 400 mg dose has been retained for short term treatment of disease flare ups in RA.OsteoarthritisThe usual recommended daily dose is 200 mg taken once daily or in two divided doses.Rheumatoid arthritisThe recommended daily dose is 200 mg taken in two divided doses.A dose of up to 400 mg daily may be used for short-term management of disease flares or exacerbations.CLINICAL TRIALS: Preliminary cardiovascular safety data from long term celecoxib clinical trials and reference to the parecoxib CABG trials are now included in the PI.Pfizer Australia is committed to patient safety and responding appropriately to any safety concerns. For further information or to obtain the full PI, contact Pfizer Medical Information on 1800 675 229.Dr Bill KetelbeySenior Medical DirectorPfizer Global PharmaceuticalsPfizer Australia/New ZealandPBS Information: Restricted Benefit. Symptomatic treatment of osteoarthritis and rheumatoid arthritis.Note: Celebrex is not subsidised for the treatment of acute pain, soft tissue injury or arthrosis without an inflammatory component.MINIMUM PRODUCT INFORMATIONCELEBREX 100 mg and 200 mg CapsulesUse: Symptomatic treatment of osteoarthritis and rheumatoid arthritis. Treatment of primary dysmenorrhoea in adults. Contraindications: Hypersensitivity to ingredients; allergic-type reactions to sulphonamides; in conjunction with NSAIDs; aspirin/NSAID sensitive asthma, urticarial/allergic reactions to aspirin or NSAIDs; peri-operatively in CABG surgery*; patients with unstable or significant established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease*. Precautions: Patients with known cardiovascular disease or risk factors, especially high risk cardiovascular patients, with significant and multiple risk factors*; history of GI ulcer disease or GI bleeding; severe hepatic impairment or renal disease; asthma; fluid retention; hypertension, heart failure; pregnancy and lactation, children < 18 years, concomitant use with ACE inhibitors or angiotensin receptor antagonists and thiazide diuretics (increased risk of renal impairment)*. Discontinue at first appearance of skin rash, mucosal lesions or any sign of hypersensitivity*. Adverse Reactions: Dyspepsia, diarrhoea, abdominal pain, peripheral oedema, rash, aggravated epilepsy*, aseptic meningitis*, very rarely serious skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)*. Dosage: Use lowest effective dose for shortest duration possible. Review long-term patients regularly (e.g. 3 monthly) .* Osteoarthritis: 200mg od or in divided doses*. Rheumatoid arthritis: 200 mg daily in two divided doses; up to 400 mg daily short term only*. Primary dysmenorrhoea (maximum 5 days)*: Day 1: 400mg od or 200mg bd. Day 2 onwards: 200mg od. An additional 200mg dose may be taken on any day if required. Presentation: Oral capsules 100mg and 200mg.Based on TGA approved PI dated 4 April 2006. Minimum PI prepared 10 April 2006.Before prescribing, please review full Product Information available from Pfizer Australia Pty Ltd.*Please note changes in Product Information.