FDA criticizes AbbVie for its handling of death complaints

Jun 11, 2018

The FDA reprimanded AbbVie in a recent report for not properly investigating death reports linked to three of its medications, including its blockbuster drug Humira.

According to a Form 483 report seen by STAT, FDA investigators visited AbbVie’s North Chicago plant late last year and found that said the company failed to “thoroughly investigate” a number of death complaints tied to Humira and Venclexta. The agency said that although AbbVie reported five deaths linked to those medications, it failed to compile historical data about those lots and didn’t find that there had been another 8 to 11 deaths each linked to the same lots. 

The agency also criticized the company’s handling of death reports linked to certain syringe kits for Lupron, which is designed to treat endometriosis, prostate cancer and other illnesses. According to the FDA, AbbVie did not document whether it evaluated reserve samples of the drug, different strengths or if there were other complaints linked to related lots of the medication.

The company responded to the FDA comments in a statement, saying that it “investigates all complaints when a death has occurred during the use of our products.”

Read the full STAT report.