Arthritis Drugs Linked to Lymphoma

Just a heads up if you have any RA patients on Enbrel, Remicade, or Humira and can't seem to find a reason to demand they go off immediately. The package insert warns of increased risk of cancer (it's not nice to fool with mother nature and eliminate your body's ability to make tumor necrosis factor), but it looks like there has been a significant amount of lymphoma associated with the use of these drugs.

This is from the FDA Advisory Committee (.com is the website). Arthritis Committee Will Reconsider TNF Inhibitor Safety March 4 FDA's Arthritis Advisory Committee will consider the possible link between tumor necrosis factor inhibitors and lymphoma at its March 4 meeting.

The committee will receive safety updates on all three marketed TNF inhibitors - Amgen's Enbrel, Centocor's Remicade and Abbott's Humira, which was approved Dec. 31, 2002. The previous TNF inhibitor safety review, on August 17, 2001, focused on the risk of immune disorders.

"As we understand it, the focus is on lymphoma and concerns for the TNF inhibitors," Amgen Exec VP-R&D Roger Perlmutter, MD, said during the firm's Jan. 23 earnings call. Amgen "has had some discussions with the FDA" and has "prepared a large briefing document," he said. "We're looking forward to reviewing it with the FDA." Abbott and Centocor are also understood to have prepared briefing material.

On March 5, the committee will review Aventis' Arava for improvement in physical function in rheumatoid arthritis; the meeting had been postponed from Jan. 30.