Bextra: Suspension of Marketing in European Union to Continue
In a June 27, 2005 press release issued by the European Medicines Agency (EMEA), the Agency's Committee for Medicinal Products for Human Use (CHMP) said that additional side effect warnings and prescribing contraindications are necessary for all COX-2 inhibitors due to the cardiovascular risks linked to this class of drugs.
Further, because the CHMP concluded that the additional risks of serious and potentially fatal skin reactions associated with the use of Bextra outweigh its benefits, it was recommended that the current suspension of the marketing of Bextra should continue. Bextra's manufacturer, Pfizer, had voluntarily suspended marketing of Bextra in the European Union in April 2005 at the request of the EMEA. The suspension of Bextra in the E.U. will be reviewed within one year, according to this June 2005 EMEA press release, during which time Pfizer has the opportunity to provide Bextra drug-safety data for consideration by the CHMP.
The CHMP confirmed its February 2005 finding that the probability of suffering a cardiovascular reaction such as a heart attack or stroke from one's use of COX-2 inhibitor drugs like Bextra was a function of dose and duration, i.e., dose-related. The Committee also confirmed its earlier finding that while serious skin reactions such as Stevens-Johnson Syndrome (SJS) occur with the use of other COX-2 inhibitors, the others are not near the relatively high skin reaction incident rate that has been associated with Bextra.
The CHMP recommended several prescribing contraindications and precautions for the remaining COX-2 inhibitors products.
In concluding its review, the CHMP maintained that when these COX-2 inhibitors are prescribed in accordance with these additional contraindications and precautions, the risk-benefit analysis for this class of drugs remains positive.
(Posted by: Tom Lamb)