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.