Posted by ed_uk on April 8, 2005, at 19:02:40 [reposted on April 9, 2005, at 11:10:11 | original URL]
EUROPEAN SUSPENSION OF BEXTRA
The EMEA has today announced a voluntary suspension of Bextra sales and
marketing, pending the completion of the review of safety of Cox 2’s, which is
ongoing. “Today’s announcement reinforces our previous advice that Cox 2’s should
be used after careful consideration of risks and benefits and the lowest effective dose
for the shortest duration of time”, says Professor Gordon Duff, Chairman of the
Committee on Safety of Medicines.
The concern about Bextra relates to reports of suspected serious skin reactions
which are now under review. This action is in line with the voluntary suspension of
Bextra in the USA. The previous advice on cardiovascular risk associated with Cox
2’s is unchanged.
In line with the European action, the MHRA is today issuing updated advice to health
professionals and patients on Bextra and advise that patients should see their doctor
at the next convenient appointment to arrange alternative pain relieving treatment.
Most suspected adverse reactions have incurred in the USA where Bextra has been
used more extensively. Professor Kent Woods, MHRA Chief Executive says “we
support the EMEA action in advising health professionals and patients of this new
safety concern. There is no immediate new risk and it is important that we review all
available data before reaching a final position.”Letter to Healthcare professionals in the UK.....................
DDL Valdecoxib v6f 070405
VOLUNTARY SUSPENSION OF VALDECOXIB (BEXTRA) BY PFIZER LTD
Dear Colleague
I am writing to inform you of the voluntary suspension of the sales and marketing of
valdecoxib (Bextra) by the manufacturer in Europe and the US. This action follows
increasing concerns about the risk of serious skin reactions, including Stevens-
Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), in addition to
established class evidence of cardiovascular risk, with the selective COX-2 inhibitors.
Safety data for valdecoxib
Valdecoxib is associated with a higher rate of serious, potentially fatal, skin reactions,
including SJS and TEN than other COX-2 inhibitors. The increased number of
reports of severe skin reactions has been particularly notable in the US, where usage
has been much higher than in Europe. Recent company figures show 155 reports of
serious cutaneous adverse reactions (SCARs) world-wide, and an overall reporting
rate of 7-8 cases per million patients. Most reported cases occurred within 2-3 weeks
of starting treatment. In the UK, it is estimated that less than 40,000 patients received
valdecoxib in the last 12 months, and we have received 2 reports of serious blistering
conditions, through the Yellow Card Scheme.
As previously noted, the evidence also suggests an increased risk of thrombotic events
associated with the selective COX-2 inhibitor class of drugs. CSM advice of 17
February 2005 still applies – see below.
Advice for patients
Patients who have been taking valdecoxib regularly for more than 3 weeks should
make a routine appointment to arrange alternative treatment, but may continue taking
valdecoxib until alternative treatment has been arranged. Patients who have recently
started valdecoxib (within the last 3 weeks) should be advised to stop treatment, to
avoid the small risk of skin reactions, and to see their doctor to arrange an alternative.
Cardiovascular safety of COX-2 inhibitors
In February, I wrote to you with updated advice on the cardiovascular risks of
selective COX-2 inhibitors (celecoxib, valdecoxib, parecoxib, etoricoxib). The same
advice applies today:
• Selective COX-2 inhibitors should not be prescribed in patients with
established ischaemic heart disease, cerebrovascular disease or those with
moderate heart failure (NHYA class II-IV).
• For all patients, the balance of gastrointestinal and cardiovascular risk
should be considered before prescribing a COX-2 inhibitor, particularly for
those with risk factors for heart disease and those taking low dose aspirin, for
whom gastrointestinal benefit has not been conclusively demonstrated.
• The lowest effective dose of COX-2 inhibitor should be used for the shortest
necessary period. Periodic re-evaluation is recommended, especially for
osteoarthritis patients who may only require intermittent treatment.
• Gastroprotective agents should be considered for patients switched to nonselective
NSAIDs.
Cardiovascular safety of non-selective NSAIDs
New advice arising from appraisal in the US highlights the current lack of long-term
clinical trial data supporting the cardiovascular safety of less selective NSAIDs such
as meloxicam, and etodolac, and non-selective NSAIDs, such as naproxen and
diclofenac. It is important to note that in the absence of clear evidence, we cannot
conclude that these medicines present the same or different cardiovascular risks as the
highly selective ‘coxibs’. The CSM is reviewing the available evidence and will
provide further advice as necessary. In the meantime, it is advisable to use the
lowest effective dose of NSAID for the shortest time necessary. No other changes
to prescribing practice are recommended at present.
Further assessment
The overall risks and benefits of selective COX-2 inhibitors, as well as other NSAIDs,
will be further reviewed in detail by CSM, and I will inform you of any new advice as
soon as it is available. Please report suspected adverse drug reactions to the MHRA
and CSM using the Yellow Card Scheme. This is an important source of information
on adverse drug reactions and we are currently piloting direct patient reporting
through the Yellow Card Scheme (website at www.yellowcard.gov.uk) and using
paper-based Patient Yellow Card report forms. Patients may contact the MHRA if
they would like a form (send an email to patientreporting@mhra.gsi.gov.uk or
telephone - ( 44) 020 7084 2101). A set of questions and answers for patients is
attached.
If you have any enquiries, please contact the MHRA (medicines) on 020-7084 2000
or e-mail info@mhra.gsi.gov.uk.
Yours sincerely
Prof. G Duff
Chairman
Committee on Safety of Medicines
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thread:481975
URL: http://www.dr-bob.org/babble/health/20050306/msgs/481975.html