January 25, 2024

NIOSH Recommends Removal of Two Drugs from Hazardous Drugs List

NIOSH is considering removing the drugs liraglutide and pertuzumab from its List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. The agency has opened a public comment period and is requesting input on its draft reevaluations of the drugs and its initial recommendations to change their status. NIOSH’s reevaluations of liraglutide and pertuzumab are based on the process for requesting drugs’ removal from or placement on the list as described in Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings. In both cases, the drugs’ manufacturers requested that NIOSH reevaluate their placement on the list. Liraglutide is in a class of medications called incretin mimetics and is used in the management of type 2 diabetes. Pertuzumab is an antineoplastic agent used in the treatment of HER2-positive metastatic breast cancer.

NIOSH determined through its reevaluations that the intrinsic molecular properties of liraglutide and pertuzumab and the nature of the specific hazards posed by exposure to these drugs mean that they are “not likely to pose [hazards] to workers in healthcare settings.” According to the Federal Register notice that explains NIOSH’s reasoning, the properties of the two drugs either limit or greatly decrease dermal, oral, and inhalation bioavailability, and repeated unintended needlestick injuries would have to occur to reach the levels required to result in adverse health effects from exposure.

The comment period regarding the status of liraglutide and pertuzumab closes on Feb. 15. Instructions for submitting comments as well as questions NIOSH would like commenters to consider can be found in the Federal Register.

NIOSH’s list of hazardous drugs in healthcare builds on a NIOSH alert from 2004 that warned healthcare employers and workers of the risks of working with hazardous drugs and discussed measures they could take to protect their health. In 2020, NIOSH announced the retitling of the list from the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings” to simply the “NIOSH List of Hazardous Drugs in Healthcare Settings,” explaining in the Federal Register that “[m]any of the drugs currently used to fight cancer function differently than those previously used” and that “antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals.” At that time, NIOSH also proposed reorganizing the list to group drugs by hazard instead of by their function. The 2020 list is available in draft form (PDF) from NIOSH, while the 2016 list remains the current update. The agency’s website states that its 2023 List of Hazardous Drugs in Healthcare Settings will be published to the NIOSH website once it’s been finalized.

For more information about hazardous drug exposures in healthcare, visit NIOSH’s website.