What happens if regulatory timetables conflict with real life? That's one question posed by a lawsuit accusing Abbott Laboratories of failing to warn patients that its arthritis drug Humira could cause serious fungal infections. A 69-year-old man has sued Abbott in Tennessee, saying that his almost-fatal case of histoplasmosis might have been prevented--or at least diagnosed sooner--had Abbott quickly acted on indications that the drug could boost the risk, Bloomberg reports.
Back in September 2008, the FDA ordered Abbott to warn patients and doctors of an increased risk of histoplasmosis in Humira patients, with the highest risk for patients who lived in the Mississippi and Ohio River valleys and also took methotrexate, according to court documents. Twenty-six days later, Frederick Delano--who lived in that region and took methotrexate--started Humira therapy.
The following February, Delano was diagnosed with histoplasmosis after VA doctors failed to identify the infection for a full month. Abbott contacted healthcare providers about the histoplasmosis risk more than a year later in May 2010. "In 2008, Fred and his physicians got no warning whatsoever that the medication which he thought would help could, in fact, kill him--and nearly did," Delano and his wife, Frances, allege in the complaint (as quoted by Bloomberg). The also say the company "stalled" on issuing the warning to protect its sales. Humira is a major blockbuster, with 2010 sales of more than $6 billion.
For its part, Abbott says it did everything the FDA asked it to do--and on time--effectively blaming the agency for any delay in getting the histoplasmosis information out. "Abbott's risk evaluation and mitigation plan was submitted to the FDA in December 2008 and approved in April 2010," a spokesperson told Bloomberg. "Abbott contacted healthcare providers well within the timeframe required by the FDA."