A Tennessee man has filed a product liability lawsuit that alleges he developed a serious fungal infection as a result of side effects of Humira, an Abbott Laboratories arthritis drug.
The Humira infection lawsuit was filed by Frederick Delano, 69, in U.S. District Court for the Western District of Tennessee against the drug maker. The complaint claims that Abbott failed to adequately warn consumers that the arthritis drug could cause fungal infections in a timely manner.
Humira (adalimumab) is a tumor necrosis factor blocker, also known as TNF blocker, which was approved by the FDA in 2003 for treatment of rheumatoid arthritis. It later gained approval for treatment of psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis, which was previously called juvenile rheumatoid arthritis. The drug pulled in sales of $6.5 billion in 2010.
In September 2008, the FDA issued a warning to health care professionals that Humira and other TNF blockers, including Enbrel, Remicade and Cimzia, carried the risk of fungal infections, including histoplasmosis, blastomycosis and coccidioidmycosis. Some of those infections could be life-threatening, the agency warned.
Delano was diagnosed with disseminated histoplasmosis in February 2009, after beginning treatment with Humira for psoriatic arthritis in October 2008.
In its warning just the month before, the FDA ordered a black box warning placed on all TNF blockers to alert patients to the risk and told the manufacturers to write a letter to health care providers. The lawsuit claims Abbott stalled on that letter until May 2010.
According to the FDA warning, people living in the Mississippi and Ohio River Valleys were at greater risk than average for the fungal infections. It also warned at the time that taking some other drugs like immune-suppressants could also increase the risk. Both of those factors applied to Delano.
The lawsuit claims that the infection almost killed Delano, and he is seeking compensatory and punitive damages against Abbott Laboratories.
In recent months, several Humira lawsuits have also been filed by individuals who developed nerve damage after taking the medication. Reports suggest that the medication may increase the risk of Central Nervous System (CNS) demyelination, which may lead to multiple sclerosis, optic neuritis, transverse myelitis, neuropathy or other nerve problems.