Recombinant human parathyroid hormone
BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7347.1218 (Published 18 May 2002) Cite this as: BMJ 2002;324:1218
Preclinical data on rat osteosarcoma were not dismissed
- Gemma Kuijpers, clinical pharmacology reviewer,
- Bruce Schneider, medical officer,
- Bruce Stadel, medical officer,
- Eric Colman (colmane@cder.fda.gov), medical officer
- US Food and Drug Administration, Center for Drug Evaluation and Research, Division of Metabolic and Endocrine Drug Products, 5600 Fishers Lane, Rockville, MD 20857, USA
- University Department of Medicine, Box 157, Addenbrooke's Hospital, Cambridge CB2 2QQ
EDITOR—As members of the United States Food and Drug Administration's division of metabolic and endocrine drug products responsible for the review of Eli Lilly's teriparatide (PTH1-34) application, we would like to respond to Reeve's editorial on recombinant human parathyroid hormone.1 Although the administration's advisory committee concluded that the company provided sufficient evidence to support the efficacy of teriparatide in the treatment of postmenopausal osteoporosis and idiopathic and hypogonadal osteoporosis in men, the committee did voice concern about osteosarcomas that developed in rats treated with the drug.
In contrast to Reeve's assertion that rats received huge doses of teriparatide, some animals developed osteosarcomas when treated with doses that were approximately three times the expected daily …
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