AbbvVie Under Fire From FDA Over Humira’s Death Complaints

June 12, 2018  Source: Fierce Pharma 191

Various AbbVie products, distributed from the company’s Illinois, North Chicago, manufacturing site, have been tied to death complaints including its biggest hit Humira. According to the FDA the drug manufacturing company has not taken correct action to probe those death complaints

Last year the FDA inspected the AbbVie North Chicago manufacturing site during which time they discovered that the company failed to do a proper investigation on five death complaints received relating to Humira and Venclexta treatments. Though the drug maker reported the deaths, it didn’t collate the historical data of the lots in question. It was later discovered that the lots were tied to another 8 to 10 deaths.

In a statement to FiercePharma, an AbbVie spokeswoman opposed the FDA reports, stating that the company “thoroughly investigates all complaints where a death has occurred during the time of the treatment using our products, and that the written complaint procedures are in place to investigate, analyze and resolve complaints.”

AbbVie’s Humira accounted for 65% of the 2017 total revenue generated in 2017 with global sales of $18.4 billion.

By Ddu