While Merck and Pfizer executives do not stop talking about bringing back Vioxx (voluntarily recalled by Merck after reports of as many as 50,000 deaths in the US alone and 140,000 personal injuries) and Bextra (FDA banned Bextra in April) despite conclusions that both drugs are too dangerous for arthritis patients, drug regulatory agencies worldwide are reconfirming that the side effects are just too serious to justify their prescriptions.
In another blow to Pfizer’s credibility, the European Medicines Agency (EMEA) has concluded that Bextra (valdecoxib) ban should remain in effect. After a lengthy review, the agency is also recommending more restrictions on other Cox-2 inhibitor drugs that continue to be available in the European Union (EU). These conclusions are similar to those of the FDA in the United States and other drug regulatory agencies in countries in Asia-Pacific region. (Related article: Risks of Cox-2 drugs)
Contrary to Pfizer’s position that Bextra is a safe drug, the EMEA concluded that the additional risks of serious and potentially fatal skin reactions associated with the use of Bextra outweigh its benefits. The suspension of Bextra will be reviewed within one year, during which time Pfizer has the opportunity to provide further safety and other relevant data before the Committee can consider the re-introduction of the product in the EU.
For the other COX-2 inhibitor drugs available in Europe (celecoxib or Celebrex, etoricoxib or Arcoxia, lumiracoxib or Prexige and parecoxib or Dynastat/Rayzon/Zapit), the EMEA agreed that the available data show an increased risk of thrombotic adverse cardiovascular reactions, such as heart attacks and strokes. Not all of these drugs are available in all countries and are often sold under other brand names.
In summary, the EMEA is recommending to GP’s that they use these drugs with extreme caution and only when no other alternative is available. While the FDA has put serious restrictions on most other NSAIDs, the EMEA says that it is still unclear “if the findings for COX-2 inhibitors are also relevant for conventional NSAIDs.” However, review for these drugs is ongoing and more guideline will be provided shortly.