Wednesday, April 27, 2011

Yuck = Biologic Drugs-Article states Humira causes permanent nerve damage

Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage

Abbott Laboratories (ABT) was sued on claims that its top-selling drug Humira caused permanent nerve damage in the feet of a Montana woman who took it for Crohn’s disease.
Two doctors who treated Kara Mae Pletan at the Mayo Clinic in 2008 said the nerve damage in her feet “was most likely due to Humira,” according to the lawsuit, which was filed today in state court in Chicago, near the company’s headquarters in Abbott ParkIllinois.
The complaint also alleges Abbott knew that Humira, which had 2010 worldwide sales of $6.5 billion, could cause peripheral neuropathy before it began marketing the drug to Crohn’s patients in 2007. Earlier this year, Abbott was sued by two arthritis sufferers in Texas andMassachusetts who claim Humira gave them cancer.
“Abbott has downplayed the risk of side effects, including the very real risk of permanent neuropathy,” Andy Vickery, Pletan’s lawyer, said in an e-mail.
Abbott initially sold Humira in 2003 as a treatment for rheumatoid arthritis. The U.S. Food and Drug Administration now approves Humira for the treatment of five additional autoimmune diseases, including Crohn’s.
Humira is expected to outsell Roche Holding AG (ROG)’s Avastin cancer medicine by 2016 to become the world’s most lucrative drug, according to a May 2010 forecast by research company EvaluatePharma.

Safety Data

“Humira has more than 12 years of clinical and safety data and best-in-class efficacy,” Adelle Infante, an Abbott spokeswoman, said in January, after the filing of the first lawsuit claiming Humira caused a Texas woman’s cancer. “The therapeutic risks associated with Humira are well known and documented in the prescribing label.”
Infante today declined to comment on the nerve-damage suit because Abbott hasn’t read the complaint.
Humira’s full package insert as of July 2004 warned that patients in clinical trials of similar types of drugs had developed more cancers than patients receiving other rheumatoid arthritis treatments. The class of drugs, known as tumor necrosis factor-blockers, prevent the body’s cancer-killing cells from working.
“The FDA has yet to focus in on the risk of neuropathy and other forms of neurological side effects, and Abbott has chosen to provide little if any information about these risks to either physicians or patients,” Pletan said in the complaint.

Issued Report

Doctors at Angers University in France issued a report in April 2006 suggesting that Humira could cause peripheral neuropathy, Pletan said in court papers.
“Abbott was actually aware of this article prior to the 2007 launch for Crohn’s,” she said.
In January, Gayathri Murthy, a Houston hospital worker, sued Abbott claiming she developed lymphoma while taking Humira for arthritis in 2005 and 2006. Earlier this month, a Massachusetts arthritis patient, Maureen Calisi, sued the company for allegedly causing her lymphoma after she took Humira from 2003 until 2008. Both cases are pending.
Both Murthy and Calisi are represented by Vickery, of Vickery, Waldner & Mallia LLP in Houston, who said he has “more than a dozen clients with legitimate legal claims involving Humira.”

Months of Injections

Pletan, 32, claims she developed small fiber peripheral neuropathy after receiving three months of Humira injections in 2008. The resulting “stabbing pains and hypersensitivity” in her feet forced her to give up outdoor activities and sell her family’s retail furniture store in Bozeman,Montana, when she could no longer work on her feet, she said in her complaint.
“The progression of the nerve damage seems to have stopped” after ceasing Humira injections, Pletan said in the filing. The nerve damage “appears to be permanent,” she said. Pletan is seeking both economic and punitive damages.
The case is Pletan v. Abbott Laboratories, 2011L004270, Circuit Court of Cook County, Illinois (Chicago).
To contact the reporters on this story: Laurel Brubaker Calkins in Houston; Margaret Cronin Fisk in Southfield, Michigan,
To contact the editor responsible for this story: Michael Hytha at

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