Correspondence
Problems Associated with the Use of Thyrogen in Patients with a Thyroid Gland
N Engl J Med 2008; 359:1738-1739October 16, 2008
- Article
To the Editor:
Juweid et al. (September 18 issue)1 describe the administration of thyrotropin alfa (Thyrogen) to a patient with thyroid cancer who still has a thyroid gland. Genzyme, the manufacturer of Thyrogen, wants to point out that all regulatory bodies, including the Food and Drug Administration, restrict the use of 0.9-mg intramuscular injections of the drug on two consecutive days to patients who have already had a total or near-total thyroidectomy. This is because of substantial transient thyroid swelling and severe hyperthyroidism that could result in some patients with a thyroid gland who receive a large dose of Thyrogen. Such effects have been reported in normal persons who received one intramuscular injection of 0.9 mg of Thyrogen.2 In addition, the death of an elderly woman with a multinodular goiter was reported after the intramuscular injection of 0.3 mg of Thyrogen on two consecutive days, followed by 75 mCi of iodine-131.3 The death of a patient with thyroid cancer who had not undergone thyroidectomy and who received four intramuscular injections of Thyrogen during a period of several days is described in the package insert and elsewhere.4 More than 300,000 patients with thyroid cancer have used Thyrogen safely, but those patients had previously undergone thyroidectomy.
James Magner, M.D.
Genzyme, Cambridge, MA 02142This letter (10.1056/NEJMc0807896) was published at www.nejm.org on September 19, 2008.
4 References1
Juweid M ,O'Dorisio T ,Milhem M . Diagnosis of poorly differentiated thyroid cancer with radioiodine scanning after thyrotropin alfa stimulation. N Engl J Med 2008;359:1295-1297
Full Text | Web of Science | Medline2
Nielsen VE ,Bonnema SJ ,Hegedus L . The effects of recombinant human thyrotropin in normal subjects and patients with goiter. Clin Endocrinol (Oxf) 2004;61:655-663
CrossRef | Web of Science | Medline3
Magner JA, Kipnes MS, Kloos RT, Law BM, Braverman LE. Cardiac effects of Thyrogen (rhTSH) in multinodular goiter (MNG) patients: a cautionary note. Presented at the 77th annual meeting of the American Thyroid Association, Phoenix, AZ, October 11–15, 2006.
4
Robbins RJ ,Driedger A . Magner J. Recombinant human thyrotropin-assisted radioiodine therapy for patients with metastatic thyroid cancer who could not elevate endogenous thyrotropin or be withdrawn from thyroxine. Thyroid 2006;16:1121-1130
CrossRef | Web of Science | Medline
Author/Editor Response
In response to Dr. Magner's concerns about critical patient safety issues, we want to emphasize that our goal was to diagnose the unknown primary tumor as being of thyroid origin.1 The patient underwent prescreening with a thyroid scan to ensure that there was not a large thyroid-tissue burden. The scan confirmed that the thyroid had largely been replaced by the tumor, with only a small amount of normal thyroid tissue left. Only then did we proceed with thyrotropin alfa (Thyrogen), which was administered in a hospital, with careful monitoring of thyroid function before and after administration. We respectfully point out that the Thyrogen package insert does not indicate that use of the drug for diagnostic or therapeutic purposes in patients who have not had a thyroidectomy is an absolute or even a relative contraindication. Use of Thyrogen is relatively common, not only for diagnostic purposes but also for use with radioiodine therapy in patients with large, occasionally toxic, nodular goiters and for use in testing with volunteers who have an intact, normal thyroid.2-4 We hope that with proper cautionary guidelines, our approach can be seen as an acceptable use of Thyrogen, with the anticipation that it may offer a course of treatment for patients with poorly differentiated thyroid cancers and very limited treatment options.
4 ReferencesMalik Juweid, M.D.
Thomas O'Dorisio, M.D.
Mohammed Milhem, M.D.
University of Iowa, Iowa City, IA 52242
malik-juweid@uiowa.edu 1
Juweid M ,O'Dorisio T ,Milhem M . Diagnosis of poorly differentiated thyroid cancer with radioiodine scanning after thyrotropin alfa stimulation. N Engl J Med 2008;359:1295-1297
Full Text | Web of Science | Medline2
Cardia MS ,Rubio IGS ,Medeiros-Neto G . Prolonged follow-up of multinodular goitre patients treated with radioiodine preceded or not by human recombinant TSH. Clin Endocrinol (Oxf) 2006;64:474-474
Web of Science | Medline3
Duick DS ,Baskin HJ . Utility of recombinant human thyrotropin for augmentation of radioiodine uptake and treatment of nontoxic and toxic multinodular goiters. Endocr Pract 2003;9:204-209
Medline4
Nielsen VE ,Bonnema SJ ,Hegedus L . Effects of 0.9 mg recombinant human thyrotropin on thyroid size and function in normal subjects: a randomized, double-blind, cross-over trial. J Clin Endocrinol Metab 2004;89:2242-2247
CrossRef | Web of Science | Medline
- Citing Articles (3)
Citing Articles
1
Rebecca S. Bahn (Chair), Henry B. Burch, David S. Cooper, Jeffrey R. Garber, M. Carol Greenlee, Irwin Klein, Peter Laurberg, I. Ross McDougall, Victor M. Montori, Scott A. Rivkees, Douglas S. Ross, Julie Ann Sosa, Marius N. Stan. (2011) Hyperthyroidism and Other Causes of Thyrotoxicosis: Management Guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid 21:6, 593-646
CrossRef2
Geraldo Medeiros-Neto, João H. Romaldini, Marcos Abalovich. (2011) Highlights of the Guidelines on the Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid 21:6, 581-584
CrossRef3
Rossana Romão, Ileana G.S. Rubio, Eduardo K. Tomimori, Rosalinda Y. Camargo, Meyer Knobel, Geraldo Medeiros-Neto. (2009) High Prevalence of Side Effects After Recombinant Human Thyrotropin–Stimulated Radioiodine Treatment with 30 mCi in Patients with Multinodular Goiter and Subclinical/Clinical Hyperthyroidism. Thyroid 19:9, 945-951
CrossRef
