terça-feira, novembro 22, 2005
Comunicado da Pfizer sobre problema com CCR5
Please be informed that a serious adverse event has occurred in the maraviroc clinical trial.
Pfizer is releasing the following statement to the advocate community:
Over a thousand patients have been enrolled in the maraviroc program to date. Pfizer has very recently become aware of a single case of hepatotoxicity in a patient receiving maraviroc. As the patient was also simultaneously receiving several drugs which have reported hepatic toxicities, the causality is unclear.
Pfizer is still gathering more information regarding this patient and has called an additional review by the independent Data Safety Monitoring Board of the maraviroc program. While this review is awaited we are providing all patients, investigators, ethics committees and regulatory authorities with currently available information.
We will comment further when we receive feedback from the DSMB and regulatory authorities.