Withdrawn all Vioxx & Ceoxx products from the Irish market

Notice type: Recall

Date: 30/09/2004


Product name or type:
Vioxx & Ceoxx

Product Classification:
selective cyclo-oxygenase (COX)-2 inhibitors

Authorisation Holder:
Merck Sharp and Dohme Ltd (MSD)

Problem Or Issue:
The IMB today confirmed that Merck Sharp and Dohme Ltd (MSD) have voluntarily withdrawn all Vioxx & Ceoxx products from the Irish market . Vioxx & Ceoxx are the brand names for rofecoxib which is used for the treatment of osteoarthritis(OA) and rheumatoid arthritis (RA). This worldwide withdrawal is being undertaken on the basis of data from one new clinical trial which indicates that rofecoxib, is associated with an increased risk of cardiovascular side effects. Patients taking Vioxx or Ceoxx are advised to contact their doctors or pharmacists regarding discontinuation of the treatment and consideration of the treatment options. 

The IMB in conjunction with MSD are in the process of notifying healthcare professionals and co-ordinating a recall of stocks of Vioxx and Ceoxx from pharmacies. The potential for development of cardiovascular adverse effects has been known for some time. This was highlighted in the patient information leaflet accompanying these products. However, the need for long term data on cardiovascular safety was identified and this was one of the objectives of this new trial. 

The IMB and its medical experts will participate in a review of other medicinal products in this class, which is scheduled to take place at European level. The results of this review and any necessary regulatory action will be taken and healthcare professionals informed accordingly.

Background Information Or Related Documents:
Background Note: 

Rofecoxib was first authorised in 1999 through a European assessment procedure in Ireland and other EU member states. It is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis, rheumatoid arthritis, acute pain and pain due to primary dysmenorrhea. It is one of a family of drugs referred to as selective cyclo-oxygenase (COX)-2 inhibitors. The safety of these products has been closely monitored by the IMB and at a European level since their authorisation.

Withdrawn all Vioxx & Ceoxx products from the Irish market Document

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