NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2014: Proposed 

Additions and Deletions to the NIOSH Hazardous Drug List 

The NIOSH Hazardous Drug Committee has reviewed all new FDA drug approvals and new drug warnings for the period since 

the first update to the list (January 2010 through December 2011. The committee reviewed 41 new drug approvals and 211 drugs 

with new warnings drugs and identified 45 drugs as potentially hazardous. Of these 45, 5 already have safe handling guidance in 

the drug package insert. Therefore, 40 drugs were identified for review by the expert panel. 

Based on public comment and a reevaluation by the NIOSH Hazardous Drug Committee we are recommending that 27 drugs be 

added to the list in addition to the 5 with the manufacturers' safe handling guidelines for a total of 30 new drugs. Additionally, we 

are recommending that one drug be removed from the 2012 list. 

We are requesting that, as members of the expert panel, you review the list of drugs that NIOSH suggests be added to the list and 

provide feedback on this list. 

The recommendations of the peer reviewers and stakeholders are summarized below along with the NIOSH recommendation. 

Pro osed Additions 

Recommendations 

Pstablished Name Peer Reviewer Stakeholder NIOSH 

abacavir 4/4 4/5 Abacavir will be listed on the 2014 hazardous drug list in 

a non-antineoplastic drug category based on malignant 

tumors in male and female mice and rats and genotoxicity 

in vivo. 

abiraterone 4/4 515 Abiraterone will be listed on the 2014 hazardous drug list 

as an antineoplastic drug. It is a Pregnancy Category X. 

ado-trastuzumab emtansine NIOSH proposes to include ado-trastuzumab emtansine 

on 20141ist based on manufacturer's recommendations 

for safe handling. It will be listed on the 2014 hazardous 

drug list as an antineoplastic drug. It is Pregnancy 

Category D. 
apomorphine 3/4 5/5 Apomorphine will be listed on the 2014 hazardous drug 

]ist in a non-antineoplastic drug category based on its 

genotoxicity in several in vitro assays. 

asparaginase Erwinia Already on the list as "asparaginase". Asparaginase will 

chrysanthemi be deleted from the list. 

bevacizumab 3/4 3/5 Bevacizumab will not be listed on the 2014 hazardous 

drug list. NIOSH had requested comments because of 

new warnings on this drug. NIOSH re-evaluated 

bevacizumab in light of new information on its 

bioavailability in the occupational setting provided by the 

manufacturer and it was detennined that the new 

warnings were not suf6cient to warrant its listing. 

brentuximab vedotin NIOSH proposes to include brentuximab vedotin on 2014 

list based on manufacturer's recommendations for safe 

handling. It will be listed on the 2014 hazardous drug list 

as an antineoplastic drug. It is Pregnancy Category D. 

cabazitaxel NIOSH proposes to include cabazitaxel on 2014 list 

based on manufacturer's recommendations for safe 

handling. It will be listed on the 2014 hazardous drug list 

as an antineoplastic drug. It is Pregnancy Category D. 

crizotinib 4/4 4/5 Crizotinib will be listed on the 2014 hazardous drug list 

as an antineoplastic drug and a Pregnancy Category D. 

deferiprone 4/4 5/5 Deferiprone will be listed on the 2014 hazardous drug list 

in a non-antineoplastic drug category based on 

genotoxicity in vitro and in vivo, and with additional 

recommendations about its reproductive risk. It is 

Pregnancy Category D. 
dexlansoprazole 2/4 1/5 Dexlansoprazole will not be listed on the 2014 hazardous 

drug list because it did not meet the NIOSH definition of 

a hazardous drug. Although some tumors were reported 

in laboratory studies, they were only seen at high does 

and the panel did not consider that there was sufficient 

evidence to list this drug. Following a final review, the 

expert panel concurred with not listing this drug as 

hazardous. 

dexmedetomidine 3/4 4/5 Initially, the expert panel recommended listing 

dexmedetomidine as a hazardous drug based on fetal 

toxicity in laboratory studies. The NIOSH Hazardous 

Drug Committee re-evaluated dexmedetomidine in light 

of new information provided by the manufacturer on the 

limited potential for occupational exposure and 

determined that it will not be listed for 2014. Following a 

final review, the expert panel concurred with not listing 

this drug as hazardous. 

dexrazoxane NIOSH proposes to include dexrazoxane on 20141ist 

based on manufacturer's recommendations for safe 

handling. It will be listed on the 2014 hazardous drug list 

as a non-antineoplastic drug with additional 

recommendations about its reproductive risk. 

eribulin 4/4 5/5 Eribulin will be listed on the 2014 hazardous drug list as 

an antineo lastic drug and a pregnancy Category D. 

erlotinib 4/4 3/5 Erlotinib will be listed on the 2014 hazardous drug list as 

an antineoplastic drug and a Pregnancy Category D. 
esomeprazole 2/4 2/5 Esomeprazole will not be listed on the 2014 hazardous 

drug list as it did not meet the NIOSI-I definition of a 

hazardous drug. Although some tuinors were reported in 

laboratory studies, they were only seen at high does and 

the panel did not consider that there was sufficient 

evidence to list this drug. Following a final review, the 

expert panel concun•ed with not listing this drug as 

hazardous. 

ezogabine 3/4 2/5 Ezogabine was initially recommended as meeting the 

criteria for a hazardous drug based on adverse fetal 

effects. 1-Iowever, most effects on the fetus were 

associated with maternal toxicity. It was re-evaluated by 

the NIOSl-I 1-lazardous Drug Comniittee and it was 

determined that it does not meet the criteria for a 

hazardous drug and v✓ill not be listed on the 2014 

hazardous drug list. Following a final review, the expert 

anel concurred with not listing this drug as hazardous. 

fingolimod 3/4 5/5 Fingolimod will be listed on the 2014 hazardous drug list 

in a non-antineoplastic drug category based on 

malformations and embryo-fetal deaths at low doses and 

the observation of malignant lyniphomas in laboratory 

studies, and with additional recommendations about its 

re roductive risk. 

fluconazole 2/4 2/5 Fluconazole will be listed on the 2014 hazardous drug list 

with specific recommendations about its reproductive 

risk. Several ofthe reviewers who recommended against 

it being listed recommended that it be placed in a 

reproductive risk category. 
fosphenytoin 2/4 4/5 Fosphenytoin is metabolized to phenytoin which is also 

listed as hazardous and is classified as IARC 2B. It will 

be listed on the 2014 hazardous drug list in a nonantineoplastic drug category with additional 

reconmiendations about its reproductive risk. It is a 

1'reganacy Category D. 

gabapentin 3/4 1/5 Gabapentin will not be listed on the 2014 hazardous drug 

list as it did not meet the NIOSH definition of a 

hazardous drug. It produced some tumors in laboratory 

studies at very higb doses. Following a final review, the 

expert panel concurred with not listing this drug as 

hazardous. 

gabapentin encarbil 2/4 2/5 Gabapentin encarbil will not be listed on the 2014 

hazardous drug list as it did not meet the NIOSH 

definition a hazardous drug. lt produced some tuinors in 

laboratory studies at very high doses. Following a final 

review, the expert panel concurred witli not listing this 

drug as hazardous. 

icatibant 3/4 4/5 Icatibant will be listed on the 2014 hazardous drug list 

with specific reconimendations about its reproductive 

risk. 

lansoprazole 2/4 1/5 Lansoprazole will not be listed on the 2014 hazardous 

drug list as it did not meet the NIOSH definition of a 

hazardous drug. 

liraglutide recombinant 4/4 4/5 Liraglutide will be listed on the 2014 hazardous drug list 

in a non-antineoplastic drug category based on black box 

warning on thyroid tuntors in patients with supporting 

evidence in laboratory studies, and with additional 

recommendations about its re roductive risk. 

lopinavir/ritonavir 3/4 2/5 Lopinavir/ritonavir was re-evaluated y the NIOSH 

Hazardous Drug Committee and it was determined that it 

does not meet the criteria for a hazardous drug and will 

not be listed on the 2014 haz.ardous drug list. 
minocycline 2/4 3/5 Minocycline was re-evaluated y the NIOSH Hazardous 

Drug Committee and it was detennined that it does not 

meet the criteria for a haz.ardous drug and will not be 

listed on the 2014 hazardous drug list. 

misoprostol 4/4 3/5 Misoprostol will be listed on the 2014 hazardous drug list 

with specific recommendations about its reproductive 

risk. It is Pregnancy Category X. 

nevirapine 3/4 3/3 Nevirapine will be listed on the 2014 hazardous drug list 

in a non-antineoplastic drug category based on 

hepatocellular adenonias and carcinomas in laboratory 

studies at doses lower than the human dose. 

omeprazole 2/4 1/5 Omeprazole will not be listed on the 2014 hazardous drug 

list as it did not ineet the NIOSH definition of a 

hazardous drug. Some hyperplasia was observed in 

laboratory studies at high doses. Following a final 

review, the expert panel concun•ed with not listing this 

drug as hazardous. 

pantoprazole 2/4 0/5 Pantoprazole will not be listed on the 2014 hazardous 

drug list as it did not meet the NIOSH definition of a 

hazardous drug. Sonie hyperplasia was observed in 

laboratory studies at high doses. Following a final 

review, the expert panel concun•ed with not listing this 

drug as hazardous. 

phenytoin 3/4 3/5 Phenytoin will be listed on the 2014 hazardous drug list 

in a non-antineoplastic drug category and is classified as 

IARC 2B with additional recommendations about its 

re roductive risk. It is Pregnancy Category D. 

propylthiouracil 2/4 3/5 Propylthiouracil will be listed on the 2014 hazardous 

drug list in a non-antineoplastic drug category based on 

IARC Group 2B classification, and with additional 

recommendations about its reproductive risk. It is 

Pregnancy Category D. 
rabeprazole 2/4 1/5 Rabeprazole will not be listed on the 2014 hazardous 

drug list as it did not meet the NIOSH definition of a 

hazardous drug. Sonie hyperplasia was observed in 

laboratory studics at high doses. Pollowing a final 

review, the experl panel concurred with not listing this 

drug as hazardous. 

spironolactone 2/4 3/5 Spironolactone will be listed on the 2014 hazardous drug 

list in a non-antineoplastic drug category based on a new 

black box warning for tumorogenicity in laboratory 

studies. 

tapentadol 2/4 1/5 Embryofetal toxicity was observed at doses that produced 

niaternal toxicity. 7'apentadol will not be listed on the 

20141iazardous drug list as it did not meet the NIOSH 

definition of a hazardous drug. Following a final review, 

the expert panel concurred with not listing this drug as 

hazardous. 

tesamorelin 3/4 4/5 Tesaniorelin will not be listed on the 2014 haz,ardous 

drug list. It is listed as a Pregnancy Category X because 

there is no beneft to a pregnant woman. The NIOSH 

Hazardous Drug Coininittee re-evaluated tesamorelin and 

determined that it did not meet the criteria for a 

hazardous drug and would not be listed for 2014. 

Following a final review, the expert panel concurred with 

not listing this drug as hazardous. 

ticagrelor 2/4 1/5 7'icagrelor produced some structural abnonnalities 

tumors at high doses in laboratory studies. ]t will not be 

listed on the 2014 hazardous drug list as it did not meet 

the NIOSH definition of a hazardous drug. Following a 

final review, the expert panel concurred with not listing 

this drug as hazardous. 
tocilizumab 2/4 1/5 Tocilizumab produced abortions and embryofetal death in 

laboratory studies in monkeys at doses above the human 

dose. Given the limited possibility for occupational 

exposures it will not be listed on the 2014 hazardous drug 

list as it did not meet the NIOSH definition of a 

hazardous drug. Following a final review, the expert 

panel concun•ed with not listing this drug as hazardous. 

topiramate 4/4 4/5 Topiramate will be listed on the 2014 hazardous drug list 

with specific recommendations about its reproductive 

risk. It is Pregnancy Category D. 

ulipristal 4/4 5/5 Ulipristal will be listed on the 2014 hazardous drug list 

with specific recommendations about its reproductive 

risk. It is Pregnancy Category X. 

vandetanib NIOSH proposes to include vandetanib on 20141ist based 

on manufacturer's recommendations for safe handling. It 

will be listed on the 2014 hazardous drug list as an 

antineoplastic drug. It is Pregnancy Category D. 

vemurafenib 4/4 4/5 Vemurafenib will be listed on the 2014 hazardous drag 

list as an antineoplastic drug. It is a Pregnancy Category 

D. 

voriconazole 4/4 4/5 Voriconazole will be listed on the 2014 hazardous drug 

list with specific recommendations about its reproductive 

risk. It is Pregnancy Category D. 

warfarin 3/4 5/5 VJarfarin will be listed on the 2014 hazardous drug list 

with specific recommendations about its reproductive 

risk. It is Pregnancy Category D. 
Pro osed Deletions 

Dru s reclassified as not meetin criteria for a hazardous dru 

tetracycline 1/2 2/2 A$er further review, tetracycline will be removed from 

the 2014 hazardous drug list. Tetracycline was originally 

listed as a hazardous drug, because it was part of a 

combination pharmaceutical that was deemed to meet the 

NIOSH definition. Tetracycline itself did not meet that 

definition when reviewed. Following a final review, the 

expert panel concurred with not listing this drug as 

hazardous.