Public statement on Parecoxib Sodium (Dynastat/Rayzon/Xapit) on the risk of serious hypersensitivity and skin reactions

22 October 2002

The European Medicines Evaluation Agency (EMEA) and its scientific committee (CPMP) have been made aware of reports of serious hypersensitivity reactions (anaphylaxis and angioedema) and serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and exfoliative dermatitis in patients treated with valdecoxib, a selective COX-2 inhibitor.

Some of these reactions have occurred in patients with a history of allergic-type reactions to sulphonamides.

Valdecoxib is the active metabolite of Parecoxib sodium. It is therefore possible that such reactions may also occur with use of Parecoxib sodium.

Parecoxib sodium is indicated in the short-term treatment of postoperative pain. Within the EU¹ it is marketed as an intravenous or intramuscular injection in Austria, Denmark, Finland, Germany, Ireland, Netherlands, Portugal, Sweden, United Kingdom and also in Norway.

Valdecoxib received a positive opinion² by the CPMP on 25 July 2002 and is currently awaiting the European Commission Decision (i.e. it is not in therapeutic use in the EU). It is already marketed in the United States and a number of other markets outside the European Union.

The EMEA wishes to point out the following important safety information:

For physicians considering therapy of patients with parecoxib sodium (Dynastat/Rayzon/Xapit):

• This product is contraindicated in patients with a history of hypersensitivity to sulphonamides
• In post marketing experience, hypersensitivity reactions including anaphylaxis, angioedema and serious skin reactions including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with valdecoxib.

Information for patients:

• If you have had allergy to antibiotics called “sulphonamides”, you may be prone to severe side effects with parecoxib (Dynastat/Rayzon/Xapit).
• If you experience
  • Skin rash, swelling of the face, lips and tongue, wheezing, difficulty in breathing or swallowing or
  • Swelling, blistering or peeling of the skin, tell your doctor, pharmacist or nurse immediately

As an urgent measure, the prescribing and patient information of Parecoxib have been modified through a rapid procedure at the request of the Marketing Authorisation Holder.Relevant changes to the product information are indicated below. The complete revised product information is available in the European Public Assessment Report of Dynastat/Rayzon/Xapit published on the EMEA Website.

The product information of Valdecoxib will be equally revised to include the new safety information.

¹ On 22 March 2002, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Dynastat/Rayzon/Xapit, which contains Parecoxib. The Marketing Authorisation Holder responsible for this medicinal product is Pharmacia.

² Valdecoxib (Bextra/Valdyne/Valdecoxib Pfizer and Kudeq, Valdecoxib Pharmacia Europe EEIG) received on 25 July 2002 a positive opinion for the following indications: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis and the treatment of primary dysmenorrhoea.

Public statement on Parecoxib Sodium (Dynastat/Rayzon/Xapit) on the risk of serious hypersensitivity and skin reactions

Reference Number: EMEA/25175/02