In a Form 483, the FDA cited AbbVie for inadequately processing its death complaints related to Humira. (AbbVie)
A number of AbbVie products coming out of its North Chicago, Illinois, manufacturing facility have been tied to death complaints, including its mammoth blockbuster Humira, and the FDA says the drugmaker has not done enough to investigate those complaints.
During an inspection at the plant late last year, FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, it didn't go back and compile historical data about death complaints tied to drugs coming from the same lots. It turns out those lots had been tied to another 8 to 11 complaints each, the FDA noted in a Form 483 seen by STAT.