An advertising executive has brought a lawsuit against Abbott Laboratories after its arthritis drug Humira led to a fungal infection which nearly ended his life.
Frederick Delano, 69, was diagnosed in February 2009 with disseminated histoplasmosis, according to a complaint filed yesterday in federal court in Memphis, Tennessee. In a May 2010 warning letter to doctors, Abbott said some Humira patients are at risk of developing the fungal infection.
“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, said in the complaint.
In September 2008, 26 days before Delano’s first dose of Humira, according to his complaint, the U.S. Food and Drug Administration ordered the Abbott Park, Illinois-based drugmaker to warn patients and doctors of an increased risk of potentially fatal Humira-induced histoplasmosis.
The FDA ordered stronger warnings for 4 arthiritis drugs, including Humira:
The drugs — Enbrel, Remicade, Humira and Cimzia — work by suppressing the immune system to keep it from attacking the body. For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it's "a double-edged sword," said the FDA's Dr. Jeffrey Siegel. That's because the drugs also lower the body's defenses to various kinds of infections...
Siegel said the investigation began with a single case of a woman taking one of the drugs who died of histoplasmosis. Delving into the case, doctors at the FDA found that the woman had been sick with the fungal infection for a long time. "This case led us to be concerned that there may be other situations in which physicians may not recognize histoplasmosis," said Siegel.
FDA officials searched the agency's database and found the 240 cases of patients taking the medications who had also developed the fungal infection. Of those, at least 21 appeared to involve a late diagnosis, and 12 of them — more than half — ultimately died.
Abbott was already under fire for promoting off-label uses of its epilepsy drug, Depakote:
Whistleblowers claim in the suits that Abbott Park, Illinois-based Abbott marketed Depakote, an epilepsy drug, for unapproved uses including agitation and aggression in patients with dementia, autism, sexual compulsion and other disorders. The government joined the False Claims Act suits in February, according to court dockets. More than 25 states also sued Abbott over the marketing of Depakote...
The company promoted the medicine for “unapproved, off- label uses in long-term care facilities, assisted-living facilities, mental retardation/developmentally disabled facilities and other like facilities” throughout the U.S., according to the complaint.
Abbott “knowingly disregarded federal law” and Food and Drug Administration rules on off-label promotion and “‘knowingly misrepresented the evidence concerning the efficacy and safety of the off-label uses” of Depakote, the U.S. said in its complaint filed in February.
In December, Abbott paid $127m to settle claims that it inflated drug prices reported to publishers such as Drug Topics Red Book by up to 1000%.