Healthy Skepticism Library item: 930

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Regulators deal with aftermath of Vioxx withdrawal
SCRIP - World Pharmaceutical News 2004 Oct 4

Full text:

The withdrawal of Merck & Co’s Vioxx has caused a flurry of activity among worldwide regulatory agencies, with the European Medicines Agency (EMEA) promising to look at all the COX-2s again and most national bodies issuing advice to doctors and patients on what to do next.

The EMEA said it would be looking at all the coxibs again, firstly because Vioxx (rofecoxib) was involved in the agency’s review of the products last year (which recommended the addition or strengthening of warnings) and secondly because two of them – Pfizer’s Dynastat (parecoxib) and Bextra
(valdecoxib) – were authorised through the centralised approval procedure.

It will be talking to the rapporteurs for the products and the companies involved to see how to take the process forward, and has already been in contact with Pfizer for its centrally authorised products. The aim, it said, was to see if any new issues have been raised since it concluded its review last November (Scrip No 2949/50, p 5).

National European agencies have issued advice to patients about what to do if they are taking rofecoxib. The new Italian medicines agency, AIFA, said patients should stop taking Vioxx and contact their doctor for a possible alternative, as did the Danish Medicines Agency, which said treatment should be stopped immediately, while Norway advised patients to see their doctor as soon as possible.

But the French agency, AFSSAPS, advised that while patients should contact their doctor, there was no urgency and they should not interrupt their treatment. If they did want to stop immediately, they should take paracetamol instead. Sweden’s MPA said it was not possible to determine whether the other coxibs might involve similar risks and until this was clear it was advising patients not to take them on a long-term basis.

The UK MHRA told patients to “contact their doctor by phone or at the next convenient appointment to arrange an alternative prescription”, noting that some 400,000 UK patients were taking the drug. The National Institute for Clinical Excellence said it had already planned to review its 2001 guidance on the COX-2s, which would no longer cover rofecoxib.

worldwide
Elsewhere, Health Canada said patients should consult their physicians about alternatives, noting that it has been actively monitoring all COX-2s for gastrointestinal and cardiovascular events since its advisory note of 2002.

In Japan, rofecoxib has still not been approved (it was in Phase III trials), while Pfizer’s celecoxib is awaiting approval (as Celecox) and will be the first COX-2 product to reach the market there. Pfizer said it expected no effect on the celecoxib approval process.

India plans to take action soon on the various domestic versions of Vioxx on the Indian market (from firms such as Ranbaxy, Sun Pharma and Torrent Pharmaceuticals). India’s drugs controller said it intended to make a decision on rofecoxib as soon as possible; some reports suggest restrictions may be imposed on its long-term use.

And there was no shortage of voices saying “I told you so”. In Australia, one of them, Dr Peter Mansfield, noted that his organisation, Healthy Skepticism, recommended in 2003 that the drugs be removed from the Australian Pharmaceutical Benefits Scheme because “they do more harm than good”.

He added: “Had our warnings been heeded, heart attacks and strokes would have been avoided as well as saving the taxpayer hundreds of millions of dollars.”