sexta-feira, junho 30, 2006
Boehringer avisa sobre efeito adverso do tipranavir
On the trial .33 with tipranavir (Aptivus), 14 patients had intracranial hemorraghe due to high changes in time of protrombine and of platelets aggregation.
This AE has not been correlated to TPV (according to BI) as the incidence of this side effect is normally 0,4% per year in treatment while in the TPV trial was of 0,2% (14 patients on 6000).
Nevertheless BI decided to inform pharmacovigilane in US and a first Dear Dr. letter was edited recently in Canada. More Dear Dr. letters are planned in Europe and US.
(ver Dear Dr. letter aqui)
BI has updated its package insert with the following Black Box warning:
APTIVUS CO-ADMINISTERED WITH 200 MG RITONAVIR HAS BEEN
ASSOCIATED WITH REPORTS OF BOTH FATAL AND NON-FATAL
INTRACRANIAL HEMORRHAGE. (SEE WARNINGS)
From the Warning section of the package insert:
Intracranial Hemorrhage
APTIVUS, co-administered with 200 mg of ritonavir, has been associated with reports of both
fatal and non-fatal intracranial hemorrhage (ICH). Many of these patients had other medical
conditions or were receiving concomitant medications that may have caused or contributed to
these events. No pattern of abnormal coagulation parameters has been observed in patients in
general, or preceding the development of ICH. Therefore, routine measurement of coagulation
parameters is not currently indicated in the management of patients on APTIVUS.
This AE has not been correlated to TPV (according to BI) as the incidence of this side effect is normally 0,4% per year in treatment while in the TPV trial was of 0,2% (14 patients on 6000).
Nevertheless BI decided to inform pharmacovigilane in US and a first Dear Dr. letter was edited recently in Canada. More Dear Dr. letters are planned in Europe and US.
(ver Dear Dr. letter aqui)
BI has updated its package insert with the following Black Box warning:
APTIVUS CO-ADMINISTERED WITH 200 MG RITONAVIR HAS BEEN
ASSOCIATED WITH REPORTS OF BOTH FATAL AND NON-FATAL
INTRACRANIAL HEMORRHAGE. (SEE WARNINGS)
From the Warning section of the package insert:
Intracranial Hemorrhage
APTIVUS, co-administered with 200 mg of ritonavir, has been associated with reports of both
fatal and non-fatal intracranial hemorrhage (ICH). Many of these patients had other medical
conditions or were receiving concomitant medications that may have caused or contributed to
these events. No pattern of abnormal coagulation parameters has been observed in patients in
general, or preceding the development of ICH. Therefore, routine measurement of coagulation
parameters is not currently indicated in the management of patients on APTIVUS.
