California’s Office of Environmental Health Hazard Assessment (OEHHA) has listed teriparatide as a chemical or substance known to the state to cause cancer under the “Formally Required to Be Labeled or Identified” listing mechanism of Proposition 65.
Teriparatide (CAS No. 52232-67-4) is a drug used to treat osteoporosis. It is commonly known by its trade name FORTEO. OEHHA’s listing of teriparatide took effect with its announcement on August 14.
The formally required to be labeled or identified mechanism is used when a state or federal agency has formally required it to be labeled or identified as causing cancer or reproductive toxicity. OEHHA is required to evaluate whether listing under Proposition 65 is required pursuant to the definitions set out in Section 25902(b).
Teriparatide has been identified and labeled to communicate a risk of cancer (FDA, 2013) in accordance with formal requirements by the US Food and Drug Administration (FDA). The FDA-approved label indicates that teriparatide therapy in patients with osteoporosis increases the risk of developing osteosarcoma (a malignant bone tumor). The label also references FORTEO®, which is a trade name of teriparatide.
There were no public comments submitted concerning the listing.