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The FDA recently approved the drug infliximab to treat moderately-to- severely active ulcerative colitis (UC) in children age 6 and older. UC is an inflammatory bowel disease (IBD) that damages the mucosal lining of the colon. Between 50,000 and 100,000 children in the United States have IBD; 40% of these children have UC.
Infliximab blocks the action of the proinflammatory cytokine, tumor necrosis factor. It should be given only to children who've responded inadequately to conventional therapy. The most common adverse reactions include infections (upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. More severe adverse reactions include serious infections, such as tuberculosis and bacterial sepsis, and malignancies, including lymphoma.
Sources: FDA approves Remicade to treat ulcerative colitis in children 6 years and older. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272997.htm. Infliximab prescription information: http://www.remicade.com/remicade/assets/hcp_ppi.pdf.
To explore a possible link between breast cancer treatment and diabetes, a study was conducted in women over age 65 being treated with tamoxifen, an antineoplastic drug that may increase diabetes risk through estrogen-inhibiting effects. After 5 years, 10% (1,445 of 14,360) of breast cancer survivors developed diabetes. Researchers concluded that tamoxifen therapy increased the incidence of diabetes in older breast cancer survivors and may exacerbate diabetes risk in susceptible patients.
Source: Lipscombe LL, Fischer HD, Lingsong Y, et al. Association between tamoxifen treatment and diabetes: a population-based study. Cancer. 2011 Sept. 20. [Epub ahead of print]
The FDA has approved eculizumab to treat atypical hemolytic uremic syndrome (aHUS), a very rare, life-threatening genetic disease that progressively damages vital organs, leading to renal failure, myocardial infarction, stroke, and death. It's the first drug approved to treat aHUS in both adults and children.
Eculizumab is a first-in-class terminal complement inhibitor that targets complement-mediated thrombotic microangiopathy responsible for morbidity and premature mortality in patients with aHUS. Common adverse reactions to eculizumab include hypertension, diarrhea, headache, anemia, nausea, vomiting, upper respiratory and urinary tract infections, and leukopenia.
Eculizumab has a boxed warning for life-threatening meningococcal infections. Currently, it's available only through a restricted program under a Risk Evaluation and Mitigation Strategy.
Sources: U.S. Food and Drug Administration. FDA approves Soliris for rare pediatric blood disorder. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272990.htm. Eculizumab prescription information: http://soliris.net/sites/default/files/assets/soliris_pi.pdf.
The FDA has released an ongoing safety review for the antiemetic ondansetron, a selective serotonin (5-HT3) receptor antagonist. Ondansetron may cause ECG changes, including prolongation of the QT interval and torsades de pointes. It shouldn't be used in patients with congenital long-QT syndrome. Cardiac monitoring is indicated for patients with heart failure, bradydysrhythmias, and electrolyte imbalances; and in those taking other medications that may prolong the QT interval.
Sources: U.S. Food and Drug Administration. Aofran (ondansetron): Drug Safety Communication-Risk of abnormal heart rhythms. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical. Ondansetron prescription information: http://us.gsk.com/products/assets/us_zofran_tablets.pdf.
Clinical trials and epidemiological evidence led researchers to believe that supplements of vitamin E and selenium could help prevent prostate cancer. To test the theory, a trial was initiated on 34,887 healthy men with an average risk of prostate cancer. Randomly assigned to four treatment groups, the men received oral supplements of placebo, vitamin E, selenium, or vitamin E plus selenium.
Over a median 7-year observation period, the incidence of prostate cancer in the vitamin E group increased 17%. Researchers concluded that men taking "a common dose and formulation of vitamin E (400 IU/d) have a significantly increased risk of prostate cancer...The lack of benefit from dietary supplementation with vitamin E or other agents with respect to preventing common health conditions...underscore[s] the need for consumers to be skeptical of health claims for unregulated over-the-counter products."
Source: Klein EA, Thompson IM, Tangen CM, et al. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011;306(14):1549-1556.
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