Brazilian Regulator Reverses Cox-2 Decision

Brazil's drug regulator, Anvisa, has issued new guidance on the safety of Cox-2 inhibitors, effectively reversing its decision to withdraw the drugs last year. Anvisa originally withdrew the drugs from circulation in the wake of controversy over US drug major Merck & Co's Vioxx.

The drug safety unit of the regulatory authority, Cateme, has now cleared Pfizer's Celebrex (celecoxib), marketed in Brazil as Celebra for its analgesic and anti-inflammatory indications. The decision, which also includes a number of other products including Arcoxia, Prexige, and Bextra, comes at a time when health authorities worldwide are reassessing risk factors associated with Cox-2 inhibitors.