Bextra sales suspended
Sales and marketing of the cyclo-oxygenase-2 (COX-2) inhibitor valdecoxib (Bextra) have been suspended following concerns about the risk of serious skin reactions.
After discussions with the European Medicines Agency (EMEA), Pfizer has
agreed to the suspension of valdecoxib (PDF 20K) as an interim measure
pending finalisation of the EMEA’s assessment of COX-2 inhibitors,
which is expected to be published later this month. Valdecoxib is associated
with a higher rate of potentially fatal skin reactions, including Stevens-Johnson
syndrome and toxic epidermal necrolysis, than other COX-2 inhibitors.
In line with this European action, the Medicines and Healthcare products
Regulatory Agency has issued updated advice on valdecoxib. The MHRA recommends
that patients who have been taking valdecoxib regularly for more than
three weeks should make an appointment to arrange alternative treatment,
but may continue taking valdecoxib until alternative treatment has been
arranged. Patients who have started valdecoxib within the past three
weeks should stop treatment and see their doctor to arrange alternative
treatment.
Pfizer said it will explore options under which it might be permitted
to resume making Bextra available. |
The
Pharmaceutical Journal
Acrobat
Reader