Advice for patients following the withdrawal of a widely-used painkiller/anti-inflammatory - Vioxx

Press release

Date:	30 Sep 2004
Time:	00:00
Subject:	Advice for patients following the withdrawal of a widely-used painkiller/anti-inflammatory - Vioxx
Contact:	Press Office 020 7084 3651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

Advice for patients following the withdrawal of a widely-used painkiller/anti-inflammatory - Vioxx

The Medicines and Healthcare products Regulatory Agency (MHRA) today issued advice following the withdrawal of a widely-used painkiller and anti-inflammatory drug Vioxx (rofecoxib).

Patients taking Vioxx should contact their doctor by phone or at the next convenient appointment to arrange an alternative prescription.

The drug is used in the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis, and in the management of acute pain. It is widely used, by an estimated 400,000 patients in the UK.

The maker of the drug, Merck Sharp & Dohme, informed the MHRA earlier today that it would be withdrawing the drug worldwide following concerns raised in a long term study that showed and increased risk of heart attack and stroke after 18 months or more.

Speaking today, the Chairman of the MHRA, Professor Sir Alasdair Breckenridge said:

"Patients taking Vioxx should contact their doctor by phone or at the next convenient appointment to arrange an alternative prescription. The Committee on Safety of Medicine has looked at this issue this morning and agreed that this message should be communicated widely to health professionals and patients without delay".

Notes to Editor

1. The safety of rofecoxib has been under continuous review since it was authorised in 1999. The product information contains warnings and precautions for patients with predisposing factors to heart attack and stroke. The Committee on Safety of Medicines has previously warned that rofecoxib lacks protection against heart attack and stroke.

2. The company will cease distribution to wholesalers on a worldwide basis with immediate effect. A recall from wholesale level is being arranged. Individual customers of wholesalers should contact their wholesaler directly to arrange return. Limited stocks of product for compassionate use remain available in the short term by direct contact with the company.

3. Media inquiries only to Vicky Wyatt on 020 7210 5656 and Alison Langley on 020 7210 5649.