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Article ; Online: Hypertension: A new safety risk for patients treated with erenumab.

Saely, Suprat / Croteau, David / Jawidzik, Laura / Brinker, Allen / Kortepeter, Cindy

2021 Volume 61, Issue 1, Page(s) 202–208

Abstract: Objective: To identify and analyze postmarketing case reports of elevated blood pressure (BP) associated with erenumab use.: Methods: A retrospective analysis of postmarketing (spontaneous) case reports of erenumab-associated elevated BP submitted to ...

Abstract	Objective: To identify and analyze postmarketing case reports of elevated blood pressure (BP) associated with erenumab use. Methods: A retrospective analysis of postmarketing (spontaneous) case reports of erenumab-associated elevated BP submitted to the FDA Adverse Event Reporting System from May 17, 2018 through April 30, 2020. A case of elevated BP was defined as (a) an initiation of a pharmacological intervention or emergency department visit or hospitalization for emergent de novo or worsening of preexisting hypertension, or (b) BP measurement of ≥140 mm Hg systolic or ≥90 mm Hg diastolic with or without baseline BP measurement reported. Reports of elevated BP associated with erenumab use were analyzed for baseline and demographic information, latency, drug-event causal association, and clinical outcome. Results: Sixty-one cases of elevated BP were identified, 86% (49/57) were women and the median age was 56 [range 24-88] years. Forty-one cases were associated with a serious outcome per regulatory criteria, including seven that specified hospitalization. No case reported an outcome of death. The median systolic BP increase was 39 (interquartile range (IQR) 32, 59) mm Hg and median diastolic BP increase was 28 (IQR 18, 41) mm Hg. A total of 27/61 (44%) cases reported treatment for elevated BP (i.e., pharmacologic intervention or emergency department visit/hospitalization). Elevated BP occurred most frequently (28/61, 46%) within a week of the first dose of erenumab. Nineteen cases (19/61, 31%) reported a history of preexisting hypertension. Conclusions: This case series suggest an association between elevated BP and use of erenumab. In light of our findings, the erenumab (Aimovig) prescribing information was amended to include hypertension in the Warnings and Precautions section.
MeSH term(s)	Adult ; Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/adverse effects ; Blood Pressure/drug effects ; Calcitonin Gene-Related Peptide Receptor Antagonists/adverse effects ; Female ; Humans ; Hypertension/chemically induced ; Male ; Middle Aged ; Retrospective Studies ; Young Adult
Chemical Substances	Antibodies, Monoclonal, Humanized ; Calcitonin Gene-Related Peptide Receptor Antagonists ; erenumab (I5I8VB78VT)
Language	English
Publishing date	2021-01-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	410130-3
ISSN	1526-4610 ; 0017-8748
ISSN (online)	1526-4610
ISSN	0017-8748
DOI	10.1111/head.14051
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Article ; Online: Ether for Wound Debridement of Wild Maggots.

Wein, Rachel E / Paplaskas, Alison / Saely, Suprat

Journal of pharmacy practice

2019 Volume 33, Issue 4, Page(s) 558–561

Abstract: Myiasis is defined as an infestation of the organs or tissues of live vertebrates (humans or animals) by dipterous larvae, commonly referred to as maggots. Wound myiasis is a common presentation in the emergency department. The presence of wild maggots ... ...

Abstract	Myiasis is defined as an infestation of the organs or tissues of live vertebrates (humans or animals) by dipterous larvae, commonly referred to as maggots. Wound myiasis is a common presentation in the emergency department. The presence of wild maggots and larvae in wounds is concerning for subsequent myiasis-induced infections and complications. Proper extraction of wild maggots and larvae is required to avoid complications that may occur with wound myiasis. Surgical debridement is often utilized to extract wild maggots and larvae, but can be painful and time-consuming. There is limited literature available on alternative approaches for removal of wild maggots and larvae. We present a case of lower extremity wound myiasis that had wild maggots and larvae successfully removed with no complications using ether. This procedure is a novel, noninvasive, and pain-free way to extract wild maggots and larvae from wound myiasis.
MeSH term(s)	Animals ; Debridement ; Ether ; Humans ; Larva ; Myiasis/diagnosis ; Myiasis/surgery
Chemical Substances	Ether (0F5N573A2Y)
Language	English
Publishing date	2019-01-20
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	1027474-1
ISSN	1531-1937 ; 0897-1900
ISSN (online)	1531-1937
ISSN	0897-1900
DOI	10.1177/0897190018815390
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Article ; Online: Safety and effectiveness of high-dose, weight-based factor VIII inhibitor bypassing activity for warfarin-induced life-threatening bleeding.

Messana, Elizabeth A / Saely, Suprat / Millis, Scott R / Levy, Phillip D

Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis

2018 Volume 29, Issue 2, Page(s) 205–210

Abstract: Previous studies suggest low, fixed-dose regimens of activated prothrombin complex concentrate [factor VIII inhibitor bypassing activity (FEIBA); 500 U for international normalized ratio (INR) ... 5] is effective for reversal of ... ...

Abstract	: Previous studies suggest low, fixed-dose regimens of activated prothrombin complex concentrate [factor VIII inhibitor bypassing activity (FEIBA); 500 U for international normalized ratio (INR) < 5; 1000 U for INR > 5] is effective for reversal of warfarin-induced life-threatening bleeds. Little data are available on the use of high-dose, weight-based FEIBA for this indication. The objective of this study was to evaluate effectiveness and safety of high-dose, weight-based FEIBA (50 U/kg) vs. frozen plasma alone in this population. This was a matched case-control, multicenter retrospective study including patients who received high-dose, weight-based FEIBA or frozen plasma alone for warfarin-induced life-threatening bleeds matched (1 : 1) based on age and bleed location. Forty-eight patients were included in the analysis (24 FEIBA, 24 frozen plasma). The primary endpoint was time to INR less than 1.5 after administration of FEIBA or frozen plasma. Secondary endpoints include rates of thromboembolic events and mortality. Median baseline INR was 3.7 (interquartile range 2.7, 7.30) and 2.9 (2.3, 6.61) in the FEIBA and frozen plasma groups, respectively (P = 0.13). Median FEIBA dose was 4530 (3672, 5028) U. Use of FEIBA resulted in faster time to INR less than 1.5 with a median of 2.5 (1.25, 4.15) vs. 12 (5.6, 28.35) h; (P < 0.0001). Thromboembolic events occurred in nine (16.7%) patients (FEIBA n = 5; plasma n = 4); (P = 1.0). Mortality was similar in both groups (FEIBA 33% vs. frozen plasma 15%; P = 0.2). The use of high-dose, weight-based FEIBA resulted in faster time to reversal of warfarin-induced coagulopathy compared with frozen plasma alone and showed a similar safety profile.
MeSH term(s)	Aged ; Case-Control Studies ; Factor VIII/pharmacology ; Factor VIII/therapeutic use ; Female ; Hemorrhage/chemically induced ; Humans ; Male ; Retrospective Studies ; Treatment Outcome
Chemical Substances	Factor VIII (9001-27-8)
Language	English
Publishing date	2018-03
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	1033551-1
ISSN	1473-5733 ; 0957-5235
ISSN (online)	1473-5733
ISSN	0957-5235
DOI	10.1097/MBC.0000000000000705
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Article ; Online: Diagnosis and treatment of drug-induced hyperthermia.

Musselman, Megan E / Saely, Suprat

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

2012 Volume 70, Issue 1, Page(s) 34–42

Abstract: Purpose: The etiology, pathophysiology, clinical presentation, and management of drug-induced hyperthermia (DIH) syndromes are reviewed.: Summary: DIH syndromes are a rare and often overlooked cause of body temperature elevation and can be fatal if ... ...

Abstract	Purpose: The etiology, pathophysiology, clinical presentation, and management of drug-induced hyperthermia (DIH) syndromes are reviewed. Summary: DIH syndromes are a rare and often overlooked cause of body temperature elevation and can be fatal if not recognized promptly and managed appropriately. There are five major DIH syndromes: (1) neuroleptic malignant syndrome, (2) serotonin syndrome, (3) anticholinergic poisoning, (4) sympathomimetic poisoning, and (5) malignant hyperthermia. The differential diagnosis of DIH syndromes can be challenging because symptoms are generally nonspecific, ranging from blood pressure changes and excessive sweating to altered mental status, muscle rigidity, convulsions, and metabolic acidosis. Evidence from the professional literature (per a MEDLINE search for articles published through November 2011) indicates that few currently available treatment options can reduce the duration of hyperthermia; therefore, prompt identification of the provoking agent based on the patient's medication history, the clinical presentation, and the timing of symptom onset is essential to determine the appropriate treatment and mitigate potentially life-threatening sequelae. For all DIH syndromes, appropriate management includes the immediate discontinuation of the suspected offending agent(s) and supportive care (external cooling, volume resuscitation as needed); in some cases, pharmacologic therapy (e.g., a benzodiazepine, bromocriptine, dantrolene) may be appropriate, with the selection of a specific agent primarily determined by the medication history and suspected DIH syndrome. Conclusion: DIH is a hypermetabolic state caused by medications and other agents that alter neurotransmitter levels. The treatment of DIH syndromes includes supportive care and pharmacotherapy as appropriate.
MeSH term(s)	Animals ; Antipsychotic Agents/adverse effects ; Cholinergic Antagonists/adverse effects ; Humans ; Malignant Hyperthermia/diagnosis ; Malignant Hyperthermia/epidemiology ; Malignant Hyperthermia/therapy ; Neuroleptic Malignant Syndrome/diagnosis ; Neuroleptic Malignant Syndrome/epidemiology ; Neuroleptic Malignant Syndrome/therapy ; Serotonin Syndrome/diagnosis ; Serotonin Syndrome/epidemiology ; Serotonin Syndrome/therapy ; Sympathomimetics/adverse effects
Chemical Substances	Antipsychotic Agents ; Cholinergic Antagonists ; Sympathomimetics
Language	English
Publishing date	2012-10-05
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1224627-x
ISSN	1535-2900 ; 1079-2082
ISSN (online)	1535-2900
ISSN	1079-2082
DOI	10.2146/ajhp110543
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Article ; Online: Neuroleptic malignant syndrome associated with the use of prochlorperazine in a patient with a recent history of antipsychotic-induced neuroleptic malignant syndrome.

Musselman, Megan E / Browning, Linda A / Parker, Dennis / Saely, Suprat

The Annals of pharmacotherapy

2011 Volume 45, Issue 11, Page(s) e61

Abstract: Objective: To describe a case of neuroleptic malignant syndrome (NMS) associated with the use of prochlorperazine in a patient recently hospitalized for NMS secondary to olanzapine.: Case summary: A 28-year-old African American male with a history of ...

Abstract	Objective: To describe a case of neuroleptic malignant syndrome (NMS) associated with the use of prochlorperazine in a patient recently hospitalized for NMS secondary to olanzapine. Case summary: A 28-year-old African American male with a history of schizophrenia was hospitalized 22 days prior to the current admission for an episode of olanzapine-induced NMS. The patient was discharged from our hospital to an outside psychiatric facility. At this facility, the patient developed nausea and was given 2 doses (unknown amount and route) of prochlorperazine. Over the next 24 hours, the patient exhibited signs and symptoms of NMS including fever, agitation, and muscle rigidity. He was transported to the emergency department and became increasingly agitated. Upon admission, the patient was hyperthermic (rectal temperature 39 °C) and tachycardic (heart rate 138 beats/min), with an elevated white blood cell count of 13.5 × 10(3)/μL, creatine kinase 431 units/L, serum sodium 150 mEq/L, blood urea nitrogen 25 mg/dL, and creatinine 1.1 mg/dL. A diagnosis of NMS was speculated and infectious causes were excluded. The patient was treated with aggressive fluid resuscitation and rapid cooling measures, as well as bromocriptine and lorazepam. Cooling measures were used for 48 hours, during which time the creatine kinase, white blood cell count, sodium, blood urea nitrogen, and creatinine gradually normalized. The patient was discharged to a psychiatry facility with a treatment regimen of oxcarbazepine 600 mg twice daily, lorazepam 2 mg 3 times daily, and clozapine 25 mg at bedtime, which was titrated over 2 months to 200 mg twice daily. There have been no further occurrences of NMS. Discussion: The patient had all of the major characteristics of NMS with no other likely causative factors that may have contributed to his illness. Use of the Naranjo probability scale suggested that NMS was probably related to prochlorperazine. This case highlights the potential increased risk with the use of prochlorperazine in a patient with a history of olanzapine-induced NMS. Conclusions: NMS should be considered as a rare complication of therapy with antipsychotics and agents that alter dopamine activity, especially in patients with a history of the syndrome. Careful consideration should be given regarding the risks and benefits of using non-antipsychotic dopamine antagonists in patients with a history of antipsychotic-induced NMS.
MeSH term(s)	Adult ; Antipsychotic Agents/adverse effects ; Antipsychotic Agents/therapeutic use ; Benzodiazepines/adverse effects ; Benzodiazepines/therapeutic use ; Humans ; Male ; Neuroleptic Malignant Syndrome/drug therapy ; Neuroleptic Malignant Syndrome/etiology ; Prochlorperazine/adverse effects ; Prochlorperazine/therapeutic use ; Schizophrenia/drug therapy
Chemical Substances	Antipsychotic Agents ; Benzodiazepines (12794-10-4) ; olanzapine (N7U69T4SZR) ; Prochlorperazine (YHP6YLT61T)
Language	English
Publishing date	2011-11
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	1101370-9
ISSN	1542-6270 ; 1060-0280
ISSN (online)	1542-6270
ISSN	1060-0280
DOI	10.1345/aph.1Q325
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Article ; Online: Temperature management in acute neurologic injury: to cool or not to cool.

Liu-DeRyke, Xi / Saely, Suprat / Rhoney, Denise H

Journal of pharmacy practice

2010 Volume 23, Issue 5, Page(s) 483–491

Abstract: Therapeutic hypothermia is becoming an important intervention following acute neurologic injury despite inconclusive results concerning efficacy. This enthusiasm primarily stems from a lack of other effective interventions in this population. With the ... ...

Abstract	Therapeutic hypothermia is becoming an important intervention following acute neurologic injury despite inconclusive results concerning efficacy. This enthusiasm primarily stems from a lack of other effective interventions in this population. With the increase in the use of therapeutic hypothermia, several practical issues must be considered when initiating this intervention. Clinical pharmacists can play an important role in anticipating and addressing some complications such as shivering, slow drug metabolism, and infection. This review will discuss the available literature concerning the efficacy of therapeutic hypothermia in various neurologic injuries, as well as the most common adverse events associated with it.
MeSH term(s)	Acute Disease ; Analgesics, Opioid/pharmacology ; Analgesics, Opioid/therapeutic use ; Animals ; Body Temperature/drug effects ; Body Temperature/physiology ; Brain Injuries/physiopathology ; Brain Injuries/therapy ; Disease Management ; Humans ; Hypnotics and Sedatives/pharmacology ; Hypnotics and Sedatives/therapeutic use ; Hypothermia, Induced/methods ; Nervous System Diseases/physiopathology ; Nervous System Diseases/therapy ; Shivering/drug effects ; Shivering/physiology ; Stroke/physiopathology ; Stroke/therapy
Chemical Substances	Analgesics, Opioid ; Hypnotics and Sedatives
Language	English
Publishing date	2010-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1027474-1
ISSN	1531-1937 ; 0897-1900
ISSN (online)	1531-1937
ISSN	0897-1900
DOI	10.1177/0897190010372335
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Article ; Online: Investigating the impact of the definition of previous antibiotic exposure related to isolation of extended spectrum β-lactamase-producing Klebsiella pneumoniae.

Saely, Suprat / Kaye, Keith S / Fairfax, Marilynn R / Chopra, Teena / Pogue, Jason M

American journal of infection control

2011 Volume 39, Issue 5, Page(s) 390–395

Abstract: Background: Previous antibiotic exposure is a risk factor for extended spectrum β-lactamase (ESBL)-producing Klebsiella pneumoniae isolation, but the optimal definition of previous antibiotic exposure remains unclear.: Methods: This was a ... ...

Abstract	Background: Previous antibiotic exposure is a risk factor for extended spectrum β-lactamase (ESBL)-producing Klebsiella pneumoniae isolation, but the optimal definition of previous antibiotic exposure remains unclear. Methods: This was a retrospective, case-control study comparing 88 patients with ESBL-producing K pneumoniae (cases) and 88 patients with non-ESBL-producing K pneumoniae (controls). Three previous antibiotic exposure definitions were analyzed, including durations of 30, 60, and 90 days prior to organism isolation. Results: The mean cohort age was 63.6 ± 16.9 years, 43% were male, and 86% were black. In bivariate analysis, third-generation cephalosporins and cefepime were associated with ESBL-producing K pneumoniae isolation, and the odds ratios (OR) were significant regardless of previous antibiotic exposure definition. However, for fluoroquinolones and ampicillin/sulbactam, the ORs varied as a function of previous antibiotic exposure definition. In multivariate analysis, third-generation cephalosporin usage was a risk factor for ESBL-producing K pneumoniae isolation, whereas ampicillin/sulbactam usage was protective against these organisms, regardless of the time frame analyzed. Other independent predictors of ESBL-producing K pneumoniae included nursing home residence (OR, 9.30 [95% confidence interval: 3.69-23.43]) and hemodialysis (OR, 13.60 [95% confidence interval: 4.29-43.17]). Conclusion: Prior use of third-generation cephalosporins, nursing home residence, and hemodialysis were independent risk factors for isolation of an ESBL-producing K pneumoniae regardless of the time frame analyzed.
MeSH term(s)	African Americans ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents/pharmacology ; Case-Control Studies ; Cephalosporins/pharmacology ; Cohort Studies ; Cross Infection/drug therapy ; Cross Infection/epidemiology ; Cross Infection/microbiology ; Female ; Fluoroquinolones/pharmacology ; Humans ; Klebsiella Infections/drug therapy ; Klebsiella Infections/epidemiology ; Klebsiella Infections/microbiology ; Klebsiella pneumoniae/drug effects ; Klebsiella pneumoniae/enzymology ; Klebsiella pneumoniae/isolation & purification ; Male ; Michigan/epidemiology ; Middle Aged ; Multivariate Analysis ; Nursing Homes ; Odds Ratio ; Renal Dialysis ; Retrospective Studies ; Risk Factors ; United States ; beta-Lactamases/drug effects
Chemical Substances	Anti-Bacterial Agents ; Cephalosporins ; Fluoroquinolones ; cefepime (807PW4VQE3) ; beta-Lactamases (EC 3.5.2.6)
Language	English
Publishing date	2011-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	392362-9
ISSN	1527-3296 ; 0196-6553
ISSN (online)	1527-3296
ISSN	0196-6553
DOI	10.1016/j.ajic.2010.08.010
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Article ; Online: Hypertension: A new safety risk for patients treated with erenumab.

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Article ; Online: Ether for Wound Debridement of Wild Maggots.

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Article ; Online: Safety and effectiveness of high-dose, weight-based factor VIII inhibitor bypassing activity for warfarin-induced life-threatening bleeding.

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Article ; Online: Diagnosis and treatment of drug-induced hyperthermia.

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Article ; Online: Neuroleptic malignant syndrome associated with the use of prochlorperazine in a patient with a recent history of antipsychotic-induced neuroleptic malignant syndrome.

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Article ; Online: Temperature management in acute neurologic injury: to cool or not to cool.

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Article ; Online: Investigating the impact of the definition of previous antibiotic exposure related to isolation of extended spectrum β-lactamase-producing Klebsiella pneumoniae.

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