FDA questions AbbVie’s procedures for handling death complaints

During an inspection AbbVie’s manufacturing plant located in North Chicago, FDA inspectors found that AbbVie had received five complaints tied to deaths after taking Humira and Venclexta. While the drugmaker reported those, the FDA says they did not 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.

Humira, with worldwide sales of $18.4 billion in 2017, accounted for about 65% of AbbVie’s total revenues that year. As for Venclexta, the FDA just allowed it to be used in combination with Rituxan as a second-line therapy for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, regardless of 17p deletion.

Click here to view the entire article.