California’s Office of Environmental Health Hazard Assessment (OEHHA) has filed a notice of intent to list mitoxantrone hydrochloride (70476-82-3) as a Proposition 65 carcinogen. The agency is proposing this action under the rarely used Formally Required to Be Labeled or Identified listing mechanism.
Mitoxantrone hydrochloride has been identified by the US Food and Drug Administration (FDA) to require specific labeling communicating the risk of cancer. FDA developed labeling language for mitoxantrone hydrochloride in 2012.
The FDA-approved warning label explains that mitoxantrone hydrochloride therapy used to treat patients with multiple sclerosis and in certain cancer patients increases the risk of developing secondary acute myeloid leukemia (a type of cancer of the lymphohematopoietic system). NOVANTRONE® is the trade name of mitoxantrone hydrochloride.
The proposed listing would require the following language to be included on the product packaging for mitoxantrone hydrochloride.
FDA-approved label Reference ID 3105100 (FDA, 2012) Under BOXED WARNING: “Secondary Leukemia: NOVANTRONE® therapy in patients with MS and in patients with cancer increases the risk of developing secondary acute myeloid leukemia.”
General. “Topoisomerase II inhibitors, including NOVANTRONE, have been associated with the development of secondary acute myeloid leukemia and myelosuppression.”
Secondary Leukemia. “NOVANTRONE® therapy increases the risk of developing secondary leukemia in patients with cancer and in patients with multiple sclerosis.”
OEHHA is requesting public comments as to whether this chemical meets the criteria for Proposition 65 listings via the formally required to be labeled or identified mechanism (Section 25902). The deadline for submissions is December 8, 2014.
Comments transmitted by e-mail should be addressed to: P65Public.Comments@-oehha.ca.gov. Please include “mitoxantrone hydrochloride” in the subject line. Comments submitted in paper form may be mailed, faxed, or delivered in person to:
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-23A
Sacramento, California 95812-4010