FDA Calls for Stronger Warnings
For Arthritis and Crohn's Drugs
By JARED A. FAVOLE
September 4, 2008 1:16 p.m.
WASHINGTON -- Federal regulators on Thursday demanded strengthened labels for four big-selling drugs for arthritis and Crohn's disease to warn about the risk of serious fungal infections.
The U.S. Food and Drug Administration wants the stronger labels for Johnson & Johnson's Remicade, Abbott Laboratories' Humira, Amgen Inc.'s and Wyeth's Enbrel,and UCB SA's Cimzia.
The FDA said it has reviewed 240 reports of histoplasmosis, a respiratory disease with symptoms similar to the flu, in patients being treated with Enbrel, Humira, or Remicade. The FDA found one case of the disease in a patient taking Cimzia. In 21 cases, health professionals didn't recognize the disease. Twelve patients died.
These drugs are part of a class of treatments known as TNF blockers. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory disease. TNF is potentially useful in destroying tumor cells, so blocking its activity in the body could raise one's risk of cancer.
Prescribing information for the drugs has included information about the risk of serious infections but the FDA said health-care professionals aren't consistently recognizing cases of histoplasmosis, a respiratory disease, and other invasive fungal infections.
Problems with TNF blockers crept up in June, when the FDA said it was investigating whether the drugs heighten the risk of cancer in children after receiving 30 reports of cancer in children who took the drugs.
The warnings could have a big impact for the companies. Johnson & Johnson's Remicade, for instance, which used to treat the chronic bowel condition Crohn's disease in children and other conditions in adults, brought in more than $3 billion in global sales in 2007.
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