The California Office of Environmental Health Hazard Assessment (OEHHA) has added mitoxantrone hydrochloride (CAS No. 70476-82-3) to the list of chemicals known to the State to cause cancer for purposes of Proposition 65. Mitoxantrone hydrochloride has been listed under Proposition 65 as causing reproductive toxicity (developmental endpoint) since July 1, 1990. The state’s chemical list has been revised to include the chemical listed under Proposition 65 as causing reproductive toxicity (developmental endpoint) and cancer.
The listing of mitoxantrone hydrochloride is based on a formal requirement by a state or federal agency that the chemical be identified or labeled as causing cancer as provided under the Act. Mitoxantrone hydrochloride has been identified or labeled to communicate a risk of cancer in accordance with formal requirements by the U.S. Food and Drug Administration. Regulations governing the listing of chemicals under the “formally required to be labeled or identified” mechanism of Proposition 65 are published in Title 27, California Code of Regulations, section 25902.
Mitoxantrone hydrochloride marketed as Novantrone is primarily used to treat multiple sclerosis. In 2005, the FDA recommended that health care professionals treating patients with Novantrone monitor cardiac functions based upon the incidence of congestive heart failure in MS patients.