Drug Safety Developments

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.”

[Article continues at original source]

J&J, Abbott, Amgen Drugs Warrant Study, IOM Says

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=alY8uPuKA8vg

J&J, Abbott, Amgen Drugs Warrant Study, IOM Says

 

By Lisa Rapaport

June 30 (Bloomberg) -- Arthritis drugs that generated $16.9 billion last year for Amgen Inc., Wyeth, Abbott Laboratories and Johnson & Johnson warrant U.S. review as part of an Obama administration push to overhaul health care, a report said.

Outside advisers told the Department of Health and Human Services today that studies should compare the effectiveness of the drugs, including Remicade from J&J, and Enbrel, marketed by Wyeth and Amgen, in a family of medicines linked to cancer. ...

 

The U.S. Food and Drug Administration said last year it was investigating a possible association between Enbrel and Remicade and childhood cancer, following 30 cases of lymphomas in patients age 18 or younger who took the anti-inflammatory drugs.

The FDA began investigating cancer cases linked to the family of medicines, known as TNF blockers, which also includes Abbott’s Humira, more than 10 years ago. The prescribing information for all of the medicines already warns of cancer risks.

The FDA also added a so-called black box warning, its strictest, to Enbrel’s prescribing information last year describing links to deadly infections including tuberculosis and bacterial sepsis.

[Read full article at original source]