Washington, DCThe same day that LawyersandSettlements.com reported that a Copenhagen study raised the red flag on Enbrel side effects (etanercept) with regard to the potential for development of inflammatory bowel disorder (IBD) in children suffering from juvenile arthritis, the US Food and Drug Administration (FDA) warned Tuesday that a group of five drugs can increase the risk of cancer in children and adolescents.
Enbrel is among the five.
According to a story this morning in the New York Times, the FDA has had the five drugs under the microscope for more than a year. The drugs in question are Remicade, Simponi, Humira, Cimzia and Enbrel. The latter, which is marketed by Amgen and Wyeth, was the biggest moneymaker of the five with sales in the US alone of $3.4 billion last year.
The drugs are prescribed to children who suffer from rheumatoid arthritis (often referred to as juvenile idiopathic arthritis or JIA), IBD and Crohn's disease. Known as tumor necrosis factor blockers, they work by neutralizing a protein that causes inflammation and damage to bones, cartilage and other tissue when overproduced.
After previously tagging the products with a black box warning, the FDA studied several dozen reports of cancer in children taking the drugs. Some of the children died. Half of all the reports studied by the FDA involved lymphomas.
The agency's findings suggest that the drugs, including Enbrel, appeared to increase the risk of cancer after they were used for longer than two and a half years.
Amgen and Wyeth, which markets Enbrel, said in a statement that they would continue working with regulators to evaluate "the potential risks and benefits" of Enbrel.
In the coming months the FDA said that it would be working with the various manufacturers to further define the scope of the cancer risk in the five drugs named. In addition to label updates, the FDA will require the manufacturers to add information with regard to the cancer risk to medication guides that are given to patients when the drugs are prescribed.
Yesterday, LawyersandSettlements.com summarized a Copenhagen study of 1,515 patients from five European registries who suffered from JIA. The study concluded that the incidence of IBD was roughly 500 cases per 100,000 patient-years of follow-up. According to Dr. Nico M. Wulffraat, of the University Medical Center Utrecht (the Netherlands), the rate is 100-fold higher than in the general population.
While noting that the incidence rate seemed "very high" Dr. Wulffraat, who headed up the study, stressed that more data was needed to confirm this early finding.