This news update on Mitoxantrone Hydrochloride is brought to you by OEHHA.
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list mitoxantrone hydrochloride as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 19861 This action is being proposed under the “Formally Required to Be Labeled or Identified” listing mechanism.
Mitoxantrone hydrochloride has been identified and labeled to communicate a risk of cancer (FDA, 2012) in accordance with formal requirements by the US Food and Drug Administration (FDA). The FDA-approved label indicates that mitoxantrone hydrochloride therapy in patients with multiple sclerosis and in patients with cancer increases the risk of developing secondary acute myeloid leukemia (a type of cancer of the lymphohematopoietic system). NOVANTRONE® is a trade name of mitoxantrone hydrochloride.
OEHHA is requesting comments as to whether this chemical meets the criteria set forth in the Proposition 65 regulations for listings via the formally required to be labeled or identified mechanism (Section 25902). Because these are ministerial listings, comments should be limited to whether FDA requires that mitoxantrone hydrochloride be labeled to communicate a risk of cancer or tumors. OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by FDA when it established the labeling requirement and will not respond to such comments if they are submitted.
For more information on Mitoxantrone Hydrochloride please visit the OEHHA link above. Please contact Nexreg for Prop 65 Compliance.