Fda: Arthritis Drugs Pose Cancer Risk to Children
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 Crohns disease.
The FDA will bolster the “black box” warning on the five drugs sold in the U.S., including Abbott Laboratories Humira, Johnson & Johnsons 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 UCBs Cimzia, which launched in May.
Shares of North Chicago-based Abbott Laboratories and New Brunswick, N.J.-based J&J fell after the FDA announcement.
Along with updating the drugs labels, the FDA is requiring companies to add information about cancer risks to the medication guides given to patients. The FDA said it is also working with the manufacturers to further define the scope of the cancer risk.
J&J said in a statement it “will coordinate closely with the FDA to ensure that health care providers, patients and caregivers are properly informed.”
Amgen and Wyeth said they will continue working with regulators to evaluate “the potential risks and benefits” of their drug.
(This version CORRECTS spelling of Cimzia)