Hospital Pharmacy - May 2017 - 328

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Hospital Pharmacy 52(5)

Class of Prescription Opioid Pain and Prescription Opioid-Containing Cough Medicines, Benzodiazepines, and Other
CNS Depressants
In an effort to decrease the use of opioids and benzodiazepines, or opioids and other CNS depressants, together, the FDA is
requiring Boxed Warnings and patient-focused Medication Guides for prescription opioid analgesics, prescription opioid-containing
cough products, benzodiazepines, and other CNS depressants with information about the serious risks associated with using these
medications at the same time. A list of included products can be found in the FDA Drug Safety Communication (approximately 400
products labels in total). FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or
cough medicines with benzodiazepines; requires its strongest warning, August 31, 2016.
https://www.fda.gov/Drugs/DrugSafety/ucm518473.htm
Added Boxed Warning (example)
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Concomitant use of opioids with benzodiazepine or other central nervous system (CNS) depressants, including alcohol, may result in
profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines,
other CNS depressants, or alcohol.

Latuda (lurasidone hydrochloride) tablets, for oral use (application number 200603)
Edited Boxed Warning (additions and/or revisions are underlined)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS; and SUICIDAL
THOUGHTS AND BEHAVIORS
Suicidal Thoughts and Behaviors
...Latuda is not approved for use in pediatric patients with depression.

Linzess (linaclotide) capsules, for oral use (application number 202811)
Edited Boxed Warning (additions and/or revisions are underlined)
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
** Linzess is contraindicated in patients less than 6 years of age; in nonclinical studies in neonatal mice, administration of a single,
clinically relevant adult oral dose of linaclotide caused deaths due to dehydration.
** Avoid use of Linzess in patients 6 years to less than 18 years of age.

Sporanox (itraconazole) Capsules (application number 020083); Sporanox (itraconazole) oral solution (application number 020657)
Edited Boxed Warning (additions and/or revisions are underlined)
Drug Interactions: Coadministration of the following drugs are contraindicated with Sporanox Capsules: ... nisoldipine, ivabradine,
ranolazine,...

Trulicity (dulaglutide) injection, for subcutaneous use (application number 125469)
Edited Boxed Warning (additions/revisions underlined)
WARNING: RISK OF THYROID C-CELL TUMORS
** In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid
C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors,
including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors
has not been determined.
** Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of
symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum
calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.


https://www.fda.gov/Drugs/DrugSafety/ucm518473.htm

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
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