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A Tennessee man has filed suit against Abbott Laboratories for failing to sufficiently issue a complete REMS program for its Humira rheumatoid arthritis treatment, because he developed a life-threatening fungal infection that he claims could have been avoided had the drugmaker acted when prompted by the FDA.

The complaint, filed in federal court in Tennessee by Fred Delano, may be one of the first product-liability lawsuits to accuse a drugmaker of moving insufficiently to develop and enact a complete REMS, or Risk Evaluation and Mitigation Strategy, which the FDA can require a drugmaker to implement to ensure safe use of drugs. Typically, such lawsuits have cited failures by drugmakers to issue black box warnings on labels.

In his lawsuit, Delano maintains that he was prescribed Humira on October 1, 2008, and received additional treatments over the ensuing months before developing histoplasmosis in February 2009. Also known as Ohio River Valley Fever, the infection is caused by fungus that grows as a mold in the soil and is usually acquired by breathing in airborne particles. Generally, the infection is most often seen in the Ohio Valley and Mississippi Valley regions (see map).

However, his lawsuit notes the FDA issued a September 4 ,2008 press release stating that upgraded warnings were being required for all TNF-inhibitors, which also includes Enbrel, Remicade and Cimzia and are made by Amgen, Johnson & Johnson and UCB, respectively. The FDA instructed the drugmakers to strengthen their existing warnings - and in the case of Humira - add information about
“opportunistic fungal infections” to a Medication Guide that will become part of a REMS (see this).

Yet, Abbott did not issue the REMS or distribute a Dear Doctor letter until spring 2010. Delano, a US Army veteran who was 66 at the time he began treatment, contends he would not have developed histoplasmosis if the REMS and related communications had been implemented before he underwent sustained treatment. The lawsuit also claims Abbott failed to sufficiently warn about histoplasmosis in its labeling and allegedly disregarded adverse event reports that might have suggested the infection was appearing at a high rate.

“Today, because Abbott has finally complied with the congressionally authorized FDA directive, Fred would get an updated and extensive Patient Medication Guide and have access to an Invasive Fungal Infection Awarenesw Educational Brochure, before he agreed to take this drug. Both now are posted by Abbott on www.humirarems.com. But 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,” the lawsuit states (read the lawsuit).

We are awaiting a comment from Abbott and will update you accordingly. UPDATE: An Abbott spokeswoman send us: “Humira has more than 12 years of clinical and safety data and best-in-class efficacy. The therapeutic risks associated with Humira are well known and documented in the prescribing label…Abbott’s Risk Evaluation and Mitigation Strategy plan was submitted to the FDA in December 2008 and approved in April 2010. Abbott contacted health care providers well within the timeframe required by the FDA.”

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