The manufacturer noted that many of those patients experiencing fatal and non-fatal bleeding in the brain had other medical conditions and were on other medications that may have contributed to the bleeding. However, the FDA has added the risk of intracranial hemmorhage to the Black Box Warning for Apitivus. Currently, routine monitoring of coagulation parameters is not indicated for those patients on Aptivus. Further studies are being conducted to determine the role Aptivus played in the intracranial hemorrhages.
Aptivus warning letter from Boehringer Ingelheim to health care professionals.
Revised prescribing information with black box warning.
