The Pharmaceutical Journal
Vol 275 No 7356 p5
2 July 2005

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European COX-2 review recommends new warnings

Additional safety warnings and new contra-indications are needed for cyclooxygenase-2 (COX-2) inhibitors because of their associated cardiovascular risks, a review by the European Medicines Agency (EMEA) has concluded. It has also recommended the suspension of Bextra (valdecoxib).

The EMEA, which began its review in November 2004, has repeated its previous recommendations that COX-2 inhibitors should not be used by patients with established ischaemic heart disease or cerebrovascular disease. It has now added peripheral arterial disease to these contraindications.

The agency also wants to see reinforced warnings for prescribers, suggesting that they exercise caution when prescribing COX-2 inhibitors for patients with risk factors for heart disease.

In addition to these warnings, the EMEA recommends suspension of the marketing authorisation for Bextra, which was voluntarily withdrawn from the European market in April by Pfizer (PJ, 16 April, p441). The EMEA review confirmed the additional risks of serious and potentially fatal skin reactions associated with valdecoxib. The suspension will be reviewed within one year.

The EMEA states that it is unclear as to whether the findings of its review of COX-2 inhibitors are relevant for conventional non-steroidal anti-inflammatory drugs.
FDA move The US Food and Drug Administration has recommended labelling revisions (equivalent to amendments to a drug’s summary of product characteristics) for all COX-2 inhibitors and other non-selective NSAIDs, including over-the-counter products. The FDA believes that more specific information about potential risks of cardiovascular and gastrointestinal adverse effects is needed by patients and prescribers.