Intermediate patient categories may require HPA axis function testing with cosyntropin to determine if AI is present. TH
Michele Kaufman is a clinical/managed care consultant and medical writer based in New York City.
References
- Lamberts SWJ, Bruining HA, de Jong FK. Corticosteroid therapy in severe illness. N Engl J Med. 1997 Oct 30;337(18):1285-1292.
- Coursin DB, Wood KE. Corticosteroid supplementation for adrenal insufficiency. JAMA. 2002 Jan 9;287(2):236-240.
- Kelley JT, Conn DL. Perioperative management of the rheumatic disease patient. Bull Rheum Dis. 2002;51(6).
- Nieman LK, Kovacs WJ. Pharmacologic use of glucocorticoids. UpToDate. Waltham, Mass. 2007. Available at: www.pharmacologic use of glucocorticoids
- Nieman LK. Clinical manifestations of Cushing’s syndrome. UpToDate. Waltham, Mass. 2007.
- Welsh GA, Manzullo EF, Nieman LK. The surgical patient taking glucocorticoids. UpToDate. Waltham, Mass. 2007. Available at: www.patients.uptodate.com/topic.asp?file=adrenal
NEW WARNINGS
Actos tablets (pioglitazone, Eli Lilly) and Avandia tablets (rosiglitazone, GlaxoSmithKline)
- These are oral thiazolidinediones (glitazones).
- They have an increased risk of heart failure. They cause fluid retention, which may lead to or exacerbate congestive heart failure. Their warnings have been updated to reflect this because these agents are sometimes prescribed to patients with heart failure. Monitor patients carefully for the development of adverse cardiac effects.
- Don’t start or continue glitazones in patients with heart failure.
Avandia tablets (rosiglitazone, GlaxoSmithKline)
- These are oral thiazolidinediones (glitazones).
- Rosiglitazone has been associated with different rates of ischemic cardiovascular events (fatal and non-fatal). However, diabetic patients have an increased risk of cardiovascular disease.
- Analysis of rosiglitazone safety is ongoing. The Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees meet jointly to discuss the cardiovascular ischemic and thrombotic risks of thiazolidinediones, especially focusing on rosiglitazone.
Additional information
- ww.fda.gov/bbs/topics/NEWS/ 2007/NEW01636.html
- www.fda.gov/cder/foi/label/2007/021073s026lbl.pdf
- www.fda.gov/cder/foi/label/2007/021071s023lbl.pdf
- “Rosiglitazone Evaluated for Cardiovascular Outcomes: An Interim Analysis,” New England Journal of Medicine. Published June 5 at www.nejm.org
Injectable Magnetic Resonance Imaging Contrast Agents: Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine), Omniscan (gadodiamide), OptiMARK (gadoversetamide), and ProHance (gadoteridol)
- These are gadolinium-based contrast agents (GBCA).
- Patients with severe kidney insufficiency (a glomerular filtration rate [GLR] <30 mL/min/1.73m2) who receive GBCA are at risk for developing nephrogenic systemic fibrosis (NSF), a debilitating and potentially fatal disease. NSF may result in fatal or debilitating systemic fibrosis.
- Patients who are pre- or post-liver transplantation or have chronic liver disease with renal insufficiency also risk developing NSF.
- Screen patients for kidney problems prior to prescribing one of these GBCA. Do not exceed the recommended dose. Ensure that the recommended time has lapsed between doses of GBCA if it is to be used again.
- Boxed warning includes avoiding use of GBCAs unless the diagnostic information is essential and unavailable with non-contrast enhanced magnetic resonance imaging. Screen all patients for renal dysfunction. For patients receiving hemodialysis (HD), consider prompt HD following use of a GBCA. Published data indicate that GBCA elimination may be enhanced with HD. It has been reported that from the first to third HD sessions that average GBCA clearance rates were 78%, 96%, and 99%, respectively. It is not known whether HD prevents NSF.
- Report possible cases of NSF to the FDA through the FDA’s MedWatch program at www.fda.gov/medwatch/report/hcp.htm.
New Indication
- Apidra (insulin glulisine), Sanofi-Aventis’ rapid-acting insulin, has been FDA approved for intravenous (IV) administration in a clinical setting under medical supervision for glycemic control in adults with Type 1 or Type 2 diabetes mellitus. This approval provides another hospital-based option for diabetic patients, who may benefit from IV therapy in a clinical setting. Apidra is already approved for use subcutaneously from the vial, via external insulin infusion pump, or via the OptiClick reusable insulin pen.
