Pharmaceutical Drug Litigation Updates

Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage

Quoted from http://www.bloomberg.com/news/2011-04-26/abbott-labs-sued-on-montana-woman-s-claim-humira-caused-nerve-damage.html

Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage

By Laurel Brubaker Calkins and Margaret Cronin Fisk - Apr 26, 2011 12:05 PM ET

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 Park, Illinois.

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 and Massachusetts who claim Humira gave them cancer.

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Abbott Sued Over Claims Arthritis Drug Caused Cancer

Quoted from http://www.bloomberg.com/news/2011-01-12/abbott-labs-arthritis-drug-humira-caused-lymphoma-cancer-texas-suit-says.html

Abbott Sued Over Claims Arthritis Drug Caused Cancer

By Laurel Brubaker Calkins - Jan 12, 2011 8:21 PM ET

Abbott Laboratories was sued by a Texas rheumatoid arthritis sufferer who claims she developed lymphoma after taking its drug Humira in a company-sponsored clinical trial in 2005.

“Abbott had the data in its possession by January 2005 to alert people to the three- to fivefold potential risk of cancer for patients taking Humira,’’ lawyer Andy Vickery said in a lawsuit filed yesterday in Houston federal court. “Abbott did nothing to warn patients directly about the risks of Humira- induced cancers’’ until federal regulators required it in 2009.

Gayathri Murthy, a Houston hospital worker, began taking Humira as part of a clinical trial in early 2005, for treatment of rheumatoid arthritis, according to the complaint. Her doctor warned her the drug increased the risk of tuberculosis and said other side effects were similar to the “side effects of aspirin.’’

She remained on the drug until she was diagnosed with lymphoma in February 2006, according to the complaint.

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US reviewing risks of Roche, Novartis, Biogen drugs

Quoted from http://www.reuters.com/article/idUSN1719273020100217

US reviewing risks of Roche, Novartis, Biogen drugs

Wed Feb 17, 2010

WASHINGTON, Feb 17 (Reuters) - U.S. health regulators are reviewing potential risks of medicines from Roche Holding AG , Novartis AG and other companies.

The Food and Drug Administration said on Wednesday it was probing reports of hearing loss with Novartis cancer drug Gleevec, hypothermia with Roche's flu drug Tamiflu and pericarditis with Biogen Idec and Elan Corp's multiple sclerosis drug Tysabri.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The lists released on Wednesday covered issues identified between April 2009 and September 2009. More than two dozen drugs were listed.

Others included rheumatoid arthritis drugs known as tumor necrosis factor (TNF blockers) for reports of demyelinating neuropathy, a neurological disorder. The FDA did not name specific TNF blockers, but the drug include Amgen and Pfizer's Enbrel, and Abbott Laboratories Inc's Humira.

Being on the list "does not mean that FDA has identified a causal relationship between the drug and the listed risk," the FDA said.

Officials at the drugmakers had no immediate comment or could not immediately be reached.

The FDA posted the lists here and here.

Arthritis Drugs Unlikely to Increase Cancer Risk

Quoted from http://www.reachmd.com/medicalnewsDetail.aspx?id=2790

Arthritis Drugs Unlikely to Increase Cancer Risk

 

MONDAY, Nov. 9 (HealthDay News) -- Rheumatoid arthritis (RA) patients who start taking anti-tumor necrosis factor α (anti-TNFα) drugs are not likely to have a higher risk of developing cancer than other groups of RA patients, according to a Swedish study in the November issue of Arthritis & Rheumatism.

Johan Askling, M.D., of Karolinska University Hospital at Solna in Stockholm, Sweden, and colleagues compared the risk of cancer in 6,366 RA patients newly being prescribed anti-TNFα treatment, 61,160 biologics-naive RA patients, 5,989 RA patients being prescribed methotrexate, 1,838 RA patients starting disease-modifying antirheumatic drug combination therapy, and the general population of Sweden.

During 25,693 person-years of follow-up, the researchers diagnosed 240 first cancers among RA patients taking anti-TNFα drugs. The risk of cancer was similar in all four groups of RA patients, with a relative risk of approximately 1.0. The relative risks did not increase with increasing time since starting anti-TNFα treatment or the total treatment time. During the first year of treatment, there was a lower risk of cancer in patients who first took etanercept and a higher risk in patients who first took infliximab or adalimumab, but these differences disappeared after one year.

"During the first six years after the start of anti-TNF therapy in routine care, no overall elevation of cancer risk and no increase with follow-up time were observed," the authors conclude.

ARTIS, the Swedish Biologics Register, which supported the study, received maintenance funding from several pharmaceutical companies, and several of the authors reported financial and consulting relationships with pharmaceutical companies.

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Arthritis Drugs to Carry Warning on Kids’ Cancer Risk

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aNB2zQF.rHdw

Arthritis Drugs to Carry Warning on Kids’ Cancer Risk

By David Olmos

Aug. 4 (Bloomberg) -- Anti-inflammatory drugs known as TNF blockers must carry stronger warnings about the increased risk of sometimes fatal cancer in children and adolescents, the U.S. Food and Drug Administration said today.

Drugs in that category include Abbott Laboratories’ Humira, Amgen Inc.’s Enbrel, Johnson & Johnson’s Remicade and Simponi, and UCB SA’s Cimzia, the FDA said in an e-mailed statement. The medicines are used to treat rheumatoid arthritis and the bowel ailment Crohn’s disease, along with other inflammatory diseases.

TNF blockers generated about $15 billion last year, according to IMS Health Inc., a Norwalk, Connecticut-based market researcher. Enbrel produced $3.6 billion in sales last year for Thousand Oaks, California-based Amgen, making it the biotechnology company’s biggest-selling drug. The stricter cancer-risk warning for the medicines stems from an investigation announced by the FDA in June 2008.

“An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average,” the FDA said. “About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.”

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