CYCLO-OXYGENASE-2 (COX-2) Bextra (valdecoxib)

Notice type: 3rd Party Publications

Date: 01/05/2005


Product name or type:
Cyclo-Oxygenase-2(COX-2) Bextra (Valdecoxib) MIMS Advisory

MIMS Publication May 2005

Problem Or Issue:
Bextra (valdecoxib) is a selective COX-2 inhibitor which was authorised for use in Ireland following an EU assessment procedure in 2003 and was indicated for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and primary dysmenorrhoea. On 7th April 2005, sales and marketing of Bextra were voluntarily suspended by the company as a precautionary measure. 

In addition to the cardiovascular risks of COX-2 inhibitors, valdecoxib is associated with a risk of serious skin reactions, including Stevens-Johnson syndrome (SJS), erythema multiforme, exfoliative dermatitis and toxic epidermal necrolysis (TEN). The number of reports of serious skin reactions has been greater in the US, where use of valdecoxib has been much higher than in Europe. However, in context of this concern, together with the evidence of cardiovascular risks associated with the class of COX-2 inhibitors, a suspension of the sale and marketing of Bextra was implemented. Prior to suspension, it is estimated that approximately 3000 patients in Ireland were undergoing treatment with Bextra. To date, the IMB has received two reports of SJS associated with the use of Bextra, since the product was first marketed in 2003. 

Healthcare professionals are advised as follows: 

• Not to initiate treatment of any new patients. 
• No repeat prescriptions for Bextra should be issued. 
• No further prescriptions for Bextra should be dispensed. 

Further to withdrawal of rofecoxib (Vioxx) in September 2004, an EU wide review of all COX-2 inhibitors, the class of products to which valdecoxib belongs was initiated. In December 2004 contraindications for patients undergoing coronary artery bypass graft and additional information and warnings on the occurrence of severe skin reactions were introduced for valdecoxib. In February 2005 contraindications and warnings concerning the cardiovascular (increased risk of non-fatal myocardial infarction and stroke) safety of all COX-2 inhibitors were introduced. This information was communicated to healthcare professionals through “Dear Healthcare Professional” letters, issued by the relevant pharmaceutical companies. In view of this data, it was agreed to accelerate the EU evaluation of the COX-2 inhibitors. The IMB is actively involved in the on-going EU review and will keep healthcare professionals informed of its progress and outcome. 

Any suspected ADRs should be notified to the IMB in the usual way. A downloadable version of the ADR report form is available form the HPRA’s website ( Downloaded forms may be completed and sent by freepost to the HPRA. Envelopes should be marked “Freepost”, Pharmacovigilance Unit, Health Products Regulatory Authority, The Earlsfort Centre, Earlsfort Terrace, Dublin 2. Alternatively completed forms may be submitted by fax (01- 6762517). Post-paid report cards are also available from the Pharmacovigilance Unit at the HPRA (01- 6764971).

Background Information Or Related Documents:
CYCLO-OXYGENASE-2 (COX-2) Bextra (valdecoxib) Document

« Back