FDA Report Says Popular Arthritis Drug Poses Cancer Risk
A group of best-selling drugs used to treat arthritis and other inflammatory diseases have been found to increase the risk of cancer in children and adolescents, prompting federal regulators on Tuesday to add stronger warning labels to the medications, The Associated Press reported.
Food and Drug Administration scientists said the drugs appear to increase the risk of cancer after being used for more than 2 1/2 years.
A yearlong study showed several dozen reports of cancer — half of which were lymphomas, a cancer that attacks the immune system — in children taking the drugs.
The drugs, known as tumor necrosis factor blockers, aid the body by neutralizing an overproduced protein that causes inflammation and damage to bones, cartilage and other tissue.
Children with rheumatoid arthritis, inflammatory bowel disorder and Crohn’s disease are often prescribed these medications.
The five drugs sold in the U.S. will receive an FDA “black box” warning.
They include 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 alone reported sales of $3.4 billion in 2008. Belgian drugmaker UCB’s Cimzia, which launched in May, will also be affected.
Shortly after the FDA announcement, shares fell for the North Chicago-based Abbott Laboratories and New Brunswick, N.J.-based J&J.
The FDA is also requiring companies to add information about cancer risks to the medication guides provided to patients. It is also working with the manufacturers to further define the scope of the cancer risk.
“J&J will coordinate closely with the FDA to ensure that health care providers, patients and caregivers are properly informed,” the company said in a statement.
Both Amgen and Wyeth said they would continue working with regulators to evaluate “the potential risks and benefits” of their drug.
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