Hospital Pharmacy - May 2017 - 327

715385
research-article2017

HPXXXX10.1177/0018578717715385Hospital PharmacyCurrent FDA-Related Drug Information

Current FDA-Related Drug Information

Summaries of Safety Labeling Changes
Approved by the FDA: Boxed Warnings
Highlights January - March 2017

The FDA's MedWatch program safety labeling changes for
boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made
to the safety information. Search of Drug Safety Labeling
Changes (SLC) database was conducted on 3/28/20174/19/2017 for date range 1/1/2017 to 3/31/2017 labeling
section "Boxed Warning". These and other label changes
are searchable in the Drug Safety Labeling Changes (SLC)
database, where data are available to the public in downloadable and searchable formats. (Drug Safety Labeling
Changes are available at: http://www.accessdata.fda.gov/

Hospital Pharmacy
2017, Vol. 52(5) 327-329
© The Author(s) 2017
Reprints and permissions:
sagepub.com/journalsPermissions.nav
https://doi.org/10.1177/0018578717715385
DOI: 10.1177/0018578717715385
journals.sagepub.com/home/hpx

scripts/cder/safetylabelingchanges/?source=govdelivery&
utm_medium=email&utm_source=govdelivery) Boxed
warnings are ordinarily used to highlight either: adverse
reactions so serious in proportion to the potential benefit
from the drug that it is essential that it be considered in
assessing the risks and benefits of using the drug; OR serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR FDA
approved the drug with restrictions to ensure safe use
because FDA concluded that the drug can be safely used
only if distribution or use is restricted.

Bicnu (carmustine) for injection, for intravenous use (application number 017422)
Edited Boxed Warning (additions/revisions are underlined)
WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY
Myelosuppression
** Bicnu causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and
overwhelming infections.
** Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior
dose. Do not administer a repeat course of Bicnu until blood counts recover.
Pulmonary Toxicity
** Bicnu causes dose-related pulmonary toxicity...

Cerebyx (fosphenytoin sodium) injection, for intravenous or intramuscular use (application number 020450)
Edited Boxed Warning (PLR conversion; additions and/or revisions underlined)
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
The rate of intravenous Cerebyx administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and
2 mg PE/kg/min (or 150 mg PE/min, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac
arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous Cerebyx ...
Class of Direct-acting Antiviral (DAA) Medicines for Hepatitis C Virus
Daklinza (daclatasvir) tablets, for oral use (application number 206843); Epclusa (sofosbuvir and velpatasvir) tablets, for oral use
(application number 208341); Harvoni (ledipasvir and sofosbuvir) tablets, for oral use (application number 205834); Olysio (simeprevir)
capsules, for oral use (application number 205123); Sovaldi (sofosbuvir) tablets, for oral use (application number 204671); Technivie
(ombitasvir, paritaprevir, and ritonavir) tablets, for oral use (application number 207931); Viekira Pak (ombitasvir, paritaprevir,
and ritonavir tablets; dasabuvir tablets), co-packaged for oral use (application number 206619); Viekira XR (dasabuvir, ombitasvir,
paritaprevir, and ritonavir) extended-release tablets, for oral use (application number 208624); Zepatier (elbasvir and grazoprevir)
tablets, for oral use (application number 208261)
Added Section to Boxed Warning
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with {PRODUCT}. HBV
reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV directacting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and
death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment followup. Initiate appropriate patient management for HBV infection as clinically indicated.


https://us.sagepub.com/en-us/journals-permissions http://journals.sagepub.com/doi/10.1177/0018578717715385 http://journals.sagepub.com/home/hpx http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery

Table of Contents for the Digital Edition of Hospital Pharmacy - May 2017

Editorial, For Sale: FDA Priority Review Vouchers
Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Pharmacists’ Knowledge of the Cost of Laboratory Testing
Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 317
Hospital Pharmacy - May 2017 - 318
Hospital Pharmacy - May 2017 - 319
Hospital Pharmacy - May 2017 - 320
Hospital Pharmacy - May 2017 - 321
Hospital Pharmacy - May 2017 - 322
Hospital Pharmacy - May 2017 - 323
Hospital Pharmacy - May 2017 - Editorial, For Sale: FDA Priority Review Vouchers
Hospital Pharmacy - May 2017 - 325
Hospital Pharmacy - May 2017 - Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Hospital Pharmacy - May 2017 - Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
Hospital Pharmacy - May 2017 - 328
Hospital Pharmacy - May 2017 - 329
Hospital Pharmacy - May 2017 - ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Hospital Pharmacy - May 2017 - 331
Hospital Pharmacy - May 2017 - 332
Hospital Pharmacy - May 2017 - 333
Hospital Pharmacy - May 2017 - Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Hospital Pharmacy - May 2017 - 335
Hospital Pharmacy - May 2017 - 336
Hospital Pharmacy - May 2017 - 337
Hospital Pharmacy - May 2017 - 338
Hospital Pharmacy - May 2017 - 339
Hospital Pharmacy - May 2017 - 340
Hospital Pharmacy - May 2017 - Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Hospital Pharmacy - May 2017 - 342
Hospital Pharmacy - May 2017 - 343
Hospital Pharmacy - May 2017 - 344
Hospital Pharmacy - May 2017 - 345
Hospital Pharmacy - May 2017 - 346
Hospital Pharmacy - May 2017 - 347
Hospital Pharmacy - May 2017 - Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Hospital Pharmacy - May 2017 - 349
Hospital Pharmacy - May 2017 - 350
Hospital Pharmacy - May 2017 - 351
Hospital Pharmacy - May 2017 - 352
Hospital Pharmacy - May 2017 - Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Hospital Pharmacy - May 2017 - 354
Hospital Pharmacy - May 2017 - 355
Hospital Pharmacy - May 2017 - 356
Hospital Pharmacy - May 2017 - Pharmacists’ Knowledge of the Cost of Laboratory Testing
Hospital Pharmacy - May 2017 - 358
Hospital Pharmacy - May 2017 - 359
Hospital Pharmacy - May 2017 - 360
Hospital Pharmacy - May 2017 - Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Hospital Pharmacy - May 2017 - 362
Hospital Pharmacy - May 2017 - 363
Hospital Pharmacy - May 2017 - 364
Hospital Pharmacy - May 2017 - 365
Hospital Pharmacy - May 2017 - 366
Hospital Pharmacy - May 2017 - Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Hospital Pharmacy - May 2017 - 368
Hospital Pharmacy - May 2017 - 369
Hospital Pharmacy - May 2017 - 370
Hospital Pharmacy - May 2017 - 371
Hospital Pharmacy - May 2017 - 372
Hospital Pharmacy - May 2017 - 373
Hospital Pharmacy - May 2017 - Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 375
Hospital Pharmacy - May 2017 - 376
Hospital Pharmacy - May 2017 - 377
Hospital Pharmacy - May 2017 - 378
Hospital Pharmacy - May 2017 - 379
Hospital Pharmacy - May 2017 - 380
Hospital Pharmacy - May 2017 - 381
Hospital Pharmacy - May 2017 - 382
Hospital Pharmacy - May 2017 - 383
Hospital Pharmacy - May 2017 - 384
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2019
http://www.nxtbook.com/nxtbooks/sage/fai_201909
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_july2019
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2019
http://www.nxtbook.com/nxtbooks/sage/canadianpharmacistsjournal_05062019
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2019
http://www.nxtbook.com/nxtbooks/sage/sri_supplement_201903
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2019
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2018
http://www.nxtbook.com/nxtbooks/sage/tec_20180810
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2018
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2018
http://www.nxtbook.com/nxtbooks/sage/fai_201807
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2018
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2018
http://www.nxtbook.com/nxtbooks/sage/sri_supplement_201803
http://www.nxtbook.com/nxtbooks/sage/slas_discovery_201712
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2018
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2017
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_november2017
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2017
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_september2017
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2017
http://www.nxtbook.com/nxtbooks/sage/fai_supplement_201709
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2017
http://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_may2017
http://www.nxtbook.com/nxtbooks/sage/fai_201706
http://www.nxtbook.com/nxtbooks/sage/fai_201607
http://www.nxtbookMEDIA.com