| LUMIRACOXIB | | MHRA | 03-Dec-07 | MHRA has issued drug updates:
Recombinant human erythropoietins: new prescribing advice
Rosiglitazone and pioglitazone: cardiovascular safety
Dosulepin: measures to reduce risk of fatal overdose
ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Short-acting ß agonists: myocardial ischaemia
Varenicline: possible effects on driving, and psychiatric illness*
NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Aprotinin: suspension of Marketing Authorisations
Lumiracoxib: suspension of Marketing Authorisations
Strontium ranelate: risk of severe allergic reactions
Talc for pleurodesis: risk of adverse events |
| LUMIRACOXIB | | MHRA | 19-Nov-07 | I am writing to inform you that the UK licences (marketing authorisations) for lumiracoxib have been suspended and stocks are being withdrawn from pharmacies, on the basis of advice from the Commission on Human Medicines (CHM).
Accordingly, no further prescriptions of lumiracoxib should be written, and patients should be reviewed to discuss alternative anti-inflammatory treatment at the next convenient opportunity.
Risk of severe liver reactions with lumiracoxib On the basis of recent adverse drug reaction (ADR) reports, CHM has advised that lumiracoxib is associated with a risk of severe, potentially life-threatening hepatotoxicity that appears greater than for a number of other authorised non-steroidal anti-inflammatory drugs.
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| LUMIRACOXIB | | MHRA | 19-Nov-07 | Please note that further to the Drug Safety Information and Public Health Link letters of 19 November 2007 (our reference EL(07)A/21), all Lumiracoxib products should be returned from Pharmacy level via suppliers within 5 days of receipt of this letter.
Recipients of this letter are asked to bring this information to the attention of relevant professionals by copy of this letter.
Primary care trusts are asked to bring this information to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.
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| LUMIRACOXIB | | MHRA | 05-Nov-07 | MHRA has issued drug updates:
Fibrates: new prescribing advice
Lumiracoxib: hepatotoxicity
Ceftriaxone: incompatibility with calcium-containing solutions
Codeine: very rare risk of side-effects in breastfed babies
St John’s wort: interactions with all antiepileptics
Illegal herbal remedies that contain Aristolochia: vigilance needed
Nasal decongestants that contain pseudoephedrine or ephedrine: sales restrictions
Moxifloxacin: hepatotoxicity and serious skin reactions—prescribing update
Co-proxamol withdrawal: reminder to prescribers
Ecoflac infusion solutions: risk of air embolism
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| LUMIRACOXIB | | Health Canada | 05-Oct-07 | These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders.
This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc. Contact the company for a copy of any references, attachments or enclosures.
Prexige* is a selective COX-2 inhibitor in the class of drugs called NSAIDs (non-steroidal anti-inflammatory drugs) indicated for the symptomatic treatment of osteoarthritis at a dose of 100 mg once daily.
Patients taking Prexige* should discontinue treatment and contact their physician for advice about alternative therapies.
Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.
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| LUMIRACOXIB | | MHRA | 01-Oct-07 | MHRA has issued drug updates:
Piroxicam: new restrictions, including specialist initiation
Ketoprofen and ketorolac: gastrointestinal risk
Inhaled corticosteroids: pneumonia
Pneumovax II: tolerability of re-vaccination
Bisphosphonates: osteonecrosis of the jaw
Lorazepam: reduction of recommended maximum daily dose
Botulinum toxin products: rare but serious risk
Rosiglitazone and pioglitazone: cardiovascular safety and fracture risk
Lumiracoxib and hepatotoxicity: prescribing update |
| LUMIRACOXIB | | Health Canada | 16-Aug-07 | OTTAWA - Health Canada is currently requesting and reviewing new safety information regarding serious liver adverse events in patients using Prexige (lumiracoxib), a Cox-2 inhibitor non-steroidal anti-inflammatory drug (NSAID).
The Canadian maximum daily dose recommended is 100 mg, whereas, in Australia, the maximum daily dose recommended ranged from 100 mg to 400 mg daily.
Once Health Canada has reviewed the available data, new information will be made public to Canadians and Canadian health care professionals, including any resulting recommendations.
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect area of the Health Canada Web site.
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