What is the maximum duration of use of teriparatide as recommended by the FDA?
There is no known toxicity of teriparatide for humans but osteosarcoma developed in rats that were treated with high doses of teriparatide. This resulted in a 'black box' warning that the maximum duration of therapy be limited to 2 years. It should be noted that the rats were given 30 to 60 times the dose of PTH (1-34) approved by the FDA for 90% of their lifespan (1).
There have been no cases of osteosarcoma seen in individuals with longstanding hyperparathyroidism (primary or secondary) or those who have been treated with teriparatide.
- Vahle JL, Sato M, Long GG, Young JK, Francis PC, Engelhardt JA, Westmore MS, Linda Y, Nold JB. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety. Toxicol Pathol 2002; 30: 312-321.