Black Box Safety Warning Ordered for Certain Children’s Drugs That Raise Risk of Cancer

By August 7, 2009Dangerous Drugs

The U.S. Food and Drug Administration has ordered the strongest safety warning possible for a class of prescription drugs called TNF blockers, HealthDay reported Aug. 4. The FDA ordered the warning for children and teenagers using these anti-inflammatory drugs after an analysis of current users showed that the drug increased their risk of cancer, including fatal cancer. The FDA said it was working with manufacturers to better understand the cancer risk of these drugs. It also included information in the black box warning about reports of psoriasis associated with TNF blockers.
The affected patients are children and teens using TNF blockers to treat juvenile rheumatoid arthritis, inflammatory bowel disorder, Crohn’s disease and other chronic inflammatory diseases. Common drugs that will get the new safety warning include Remicade (infliximab), Humira (adalimumab), Enbrel (etancercept), Cimzia (certolizumab pegol) and Simponi (golimumab). All of these drugs are tumor necrosis factor-alpha blockers or inhibitors, which means they stop the action of a body chemical that promotes inflammation of tissues. Too much of that chemical is believed to be responsible for the inflammation and tissue damage involved in conditions like rheumatoid arthritis, which can be crippling.
The FDA’s study found that children and teens using these prescription drugs had an increased risk of cancer, though they did not specify how much greater the risk was. The cancers began an average of 30 months after treatment, and about half of the cancers were lymphomas, a type of immune system cancer. Some of the cases were fatal. This study was launched in June of 2008, a month before the New England Journal of Medicine published the case of an adult woman who developed lung cancer after taking TNF blockers for Crohn’s disease. When she stopped the drug, her cancer vanished. A doctor with the Arthritis Foundation told HealthDay that patients should weigh the risks of taking TNF blockers against the benefits, which include preventing disability and deformation in children with juvenile rheumatoid arthritis.
The same doctor mentioned that patients with inflammatory illnesses are already at an increased risk of cancer. Given that fact, adding an even greater risk of cancer by using TNF blockers sends up red flags for me, as a dangerous prescription drug attorney. Current and future patients can talk to their doctors about risks versus benefits — but for children and teens who have already developed cancer because of taking TNF blockers, it’s too late to make an informed decision. These kids may already have developed life-threatening lymphomas or other cancers, and their families may have racked up many thousands of dollars in medical bills to fight the cancer.


Drug makers are strictly liable for these and other injuries caused by defects in their products, including their failure to adequately warn patients about the safety risks. That means patients who have developed cancer because of treatment with Humira, Remicade and other TNF inhibitor drugs can hold the manufacturers legally liable with a defective prescription drug lawsuit. Carey, Danis & Lowe can help. Based in St. Louis and southern Illinois, our firm represents people from around the United States who developed serious medical problems or lost a loved one because of a defective medication. Our drug injury lawyers fight for injured patients, securing the money they need to cover medical bills, replace lost income and pay other costs related to the drug injury. We can also secure compensation for the injuries themselves; the physical pain and emotional trauma they cause; or the devastating, unexpected loss of a loved one.
If you or a loved one has developed cancer after taking any TNF-alpha blocker, you should talk to the Lowe Law Firm right away. To set up a free consultation, please contact us through the Internet or call toll-free from anywhere in the U.S. at 1-877-678-3400.