Matthew Perrone, Associated Press
Federal regulators on Tuesday added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents.
After more than a year of review, Food and Drug Administration scientists said the drugs appear to increase the risk of cancer after they are used beyond 2 1/2 years. The agency studied several dozen reports of cancer in children taking the drugs, some of which were fatal. Half of the cases were lymphomas, a cancer that attacks the immune system.
The drugs are known as tumor necrosis factor blockers and work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue. The drugs are prescribed to children with rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease.
The FDA will bolster the “black box” warning on the five drugs sold in the United States, including Abbott Laboratories’ Humira, Johnson & Johnson’s Remicade and Simponi, and Enbrel, which is co-marketed by Amgen Inc. and Wyeth. All the products are multibillion-dollar sellers. Enbrel was the biggest moneymaker of the group with sales of $3.4 billion last year.
The action also affects Belgian drugmaker UCB’s Cimzia, which launched in May.