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Source: Associated Press

Cancer Warning Added to Blockbuster Anti-Inflammatory Drugs
Multibillion-dollar sellers found to increase cancer risk in children and adolescents.

After more than a year of review, F.D.A. scientists have concluded that a group of best-selling drugs used to treat arthritis and other inflammatory disease can increase the risk of cancer in children and adolescents.

The agency studied several dozen reports of cancer, some fatal, in children taking the drugs. 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. One of the drugs was also recently approved for pediatric use to treat psoriasis.

The drug agency will bolster the “black box” warning on five drugs sold in the United States, including Abbott Laboratories’ Humira, Johnson & Johnson’s Remicade and Simponi, and Enbrel, which is marketed by Amgen and Wyeth.

All the products are multibillion-dollar sellers. Enbrel was the biggest moneymaker of the group, with sales in the United States of $3.4 billion last year.

The action also affects Cimzia, which was introduced in May by the Belgian drug maker UCB.

Federal regulators added the stronger warnings to the drugs since they appear to increase the risk of cancer after they were used for more than two and a half years.

Along with updating the drugs’ labels, the F.D.A. is requiring companies to add information about cancer risks to the medication guides given to patients. The agency said it was also working with the manufacturers to further define the scope of the cancer risk.

Johnson & Johnson said in a statement that it would “coordinate closely with the F.D.A. to ensure that health care providers, patients and caregivers are properly informed.”

Amgen and Wyeth said they would continue working with regulators to evaluate “the potential risks and benefits” of their drug.