Featured Items: infliximab (Remicade) approved for pediatric ulcerative colitis; tumor necrosis factor-alpha (TNFa) blocker safety warning; ondansetron (Zofran) safety warning. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.
Infliximab (Remicade®) — FDA Approved for Pediatric Ulcerative Colitis
Janssen Biotech announced a September 2011 U.S. Food and Drug Administration (FDA) approval for their Tumor Necrosis Factor-alpha (TNFa) blocker Remicade to treat moderate-to-severe episodes of ulcerative colitis in children 6 years and older who have not responded adequately to conventional therapies. Remicade has previously been approved for the treatment of adult ulcerative colitis as well as other autoimmune diseases. The approval was based on a safety and efficacy multi-center, randomized study in 60 children, aged 6 to 17 years of age, who had failed to respond to other therapies for ulcerative colitis. By trial's end, 73% of pediatric participants showed a Remicade-induced clinical response with a safety profile that was consistent with adult patients. In addition to Boxed Warnings regarding the risk of serious infection (also see notice below), cases of unusual cancers have been reported in adolescent patients using TNFa blockers. For complete safety and administration details, see the prescribing information and Medication Guide.
Tumor Necrosis Factor-alpha (TNFa) Blockers — FDA Safety Alert
In September 2011, the FDA informed healthcare professionals of a Boxed Warning modification for the class of drugs known as Tumor Necrosis Factor-alpha (TNFa) blockers. The precautions on the labels of 5 TNFa blockers — including infliximab (Remicade®), etanercept (Enbrel®), adalimumab (Humira®), certolizumab pegol (Cimzia®), and golimumab (Simponi®) — have been revised to warn clinicians and users of the increased risk of infection from 2 bacterial pathogens, Legionella and Listeria. The decision was made following an FDA review of reports of bacterial infections found in patients taking TNFa blockers, sometimes concomitantly with immunosuppressive agents. These infections can be serious, even fatal, and risk-benefit ratios should be evaluated in patients who have underlying health conditions that make them prone to infection. Because TNFa blockers can lower a person's infection-fighting power, healthcare professionals should ask patients being prescribed these agents if they are being treated for infection. For more information, consult the prescribing information for each TNFa blocker product as needed and read the FDA Drug Safety Communication.
Ondansetron (Zofran®) — FDA Safety Alert
In a September 2011 safety communication, the FDA alerted healthcare professionals and consumers to the increased risk of heart arrhythmias in patients taking Zofran for nausea and vomiting, which would include patients prescribed the drug to ameliorate opioid-related nausea. Cases of transient electrocardiographic changes — including prolonged QT intervals and Torsade de Pointes — have been reported. Because an arrhythmia can lead to abnormal and even fatal heart rhythms, the product should not be prescribed for patients with underlying heart conditions like congenital long QT syndrome. The product is available in several formulations: standard and orally-disintegrating tablets, oral solutions, and intravenous preparations. Patients should not stop taking Zofran before discussing it with their healthcare provider. The FDA indicated that an ongoing safety review will be completed over the next year but has determined that a safety revision on product labels is warranted at this time. For complete information, read the Zofran oral products prescribing information, the Zofran prescribing information for injectables, and the FDA Drug Safety Communication.