Mesalazine-Induced Interstitial Nephritis; Psychiatric Drug-Induced Fatal Abdominal Compartment Syndrome; Severe Pelvic Organ Prolapse following Initiation of High-Dose Glucocorticoids; Vancomycin-Induced Severe Neutropenia and Rechallenge Leading to Agranulocytosis; Fatalities Associated with Sodium Phosphate Enemas; Prochlorperazine and Akathisia; Nocturnal Leg Cramps and Preceding Drug Use; Distressing Adverse Events with Citalopram and after Antidepressant Switch; Adverse Drug Reaction Deaths in the United States, 1999-2006

2012 ◽  
Vol 47 (5) ◽  
pp. 333-337
Author(s):  
Joel Sinister
Keyword(s):  
United States ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Sodium Phosphate ◽  
The United States ◽  
Pelvic Organ ◽  
Severe Neutropenia ◽  
High Dose ◽  
Drug Induced ◽  
Abdominal Compartment

Managing Multiple Myeloma in the Face of Drug-Induced Adverse Drug Reaction

2020 ◽  
pp. 089719002097776
Author(s):  
John A. Dougherty ◽  
Christopher T. Elder
Keyword(s):  
Multiple Myeloma ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Cytochrome P450 ◽  
Liver Injury ◽  
Acute Hepatitis ◽  
The United States ◽  
Blood Levels ◽  
Drug Induced ◽  
Cytochrome P450 Isoenzyme

Drug-induced liver injury has been reported to cause up to 10% of adverse drug reactions in the United States. Risk factors for druginduced liver injury include female gender, older age, interacting medications and drugs that are metabolized by the liver. This case report describes a patient who was newly initiated on tizanidine, an alpha2 adrenergic agonist used for muscle spasm and musculoskeletal pain, and bortezomib, a proteasome inhibitor used for multiple myeloma. Both medications are metabolized by cytochrome P450 isoenzyme 1A2. The medications were suspected of causing acute hepatitis based on the timing of their initiation and evidence to suggest that they can cause acute hepatitis. The Naranjo adverse drug reaction scale was scored as possible. In addition, the drugs’ blood levels may have been increased by acyclovir and hydralazine, both inhibitors of cytochrome P450 isoenzyme 1A2. A dilemma for the team was how to best manage bortezomib. It is part of first line treatment for multiple myeloma when combined with lenalidomide and dexamethasone. Other proteasome inhibitors are available for multiple myeloma treatment. When starting chemotherapy, it is important to be aware of medications that cause a rise in liver enzymes, potential drug interactions, and how best to manage the clinical consequences.

Non-chemotherapy drug-induced agranulocytosis in a tertiary hospital

2015 ◽  
Vol 35 (3) ◽  
pp. 244-250 ◽  
Author(s):  
R Navarro-Martínez ◽  
E Chover-Sierra ◽  
O Cauli
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Hospital ◽  
Negative Association ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Drug Induced ◽  
Common Drug ◽  
Low Incidence ◽  
Stimulating Factor

Drug-induced agranulocytosis is a rare haematological disorder considered as severe adverse drug reaction. Due to its low incidence, the number of studies are low and the variability of clinical features and presentation in hospitalized patients is rarely described. Awe performed an observational, transversal and retrospective study in the haematology and toxicology unit in a tertiary hospital located in Spain (Valencia) (1996–2010) in order to assess its incidence, the drugs involved, the management and outcomes of drug-induced agranulocytosis. Twenty-one cases of agranulocytosis were retrieved. All of them presented severe and symptomatic agranulocytosis (fever and infection). The most common drug associated with drug-induced agranulocytosis was metamizole administration but other drugs belonging to different pharmacological classes as well (carbimazol, sulfasalazine, bisoprolol, itraconazole, amitryptiline, ketorolac and claritomicine+cefuroxime). No differences between sex and age were found in relationship with the manifestations or course of agranulocytosis. In contrast, a significantly negative association was found between age of patients and the percentage of increase in neutrophil count. Administration of human granulocyte colony-stimulating factor did not significantly enhance the recovery of the process or the restoration of leucocytes count, suggesting a limited utility in this type of agranulocytosis.

Teaching of Pelvic Organ Prolapse Quantification System Among Obstetrics/Gynecology and Urology Residents in the United States

2012 ◽  
Vol 18 (1) ◽  
pp. 35-38 ◽  
Author(s):  
Alejandro D. Treszezamsky ◽  
Gilad Filmar ◽  
Georgia Panagopoulos ◽  
Michael D. Vardy ◽  
Charles J. Ascher-Walsh
Keyword(s):  
United States ◽  
Pelvic Organ Prolapse ◽  
The United States ◽  
Pelvic Organ ◽  
Pelvic Organ Prolapse Quantification

Safety and Efficacy of High-dose Rhesus-Human Reassortant Rotavirus Vaccines-Report of the National Multicenter Trial

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. A38-A38 ◽  
Author(s):  
Margaret B. Rennels ◽  
Roger I. Glass ◽  
Penelope H. Dennehy ◽  
David I. Bernstein ◽  
Michael E. Pichichero ◽  
...  
Keyword(s):  
United States ◽  
Medical Center ◽  
The United States ◽  
Multicenter Trial ◽  
High Dose ◽  
Rotavirus Vaccine ◽  
Kaiser Permanente ◽  
Safety And Efficacy ◽  
Rotavirus Vaccines ◽  
Medical Office

In the January 1996 article titled "Safety and Efficacy of High-dose Rhesus Human Reassortant Rotavirus Vaccines—Report of the National Multicenter Trial" (Rennels et al. Pediatrics, 1996:97:7-13), the Acknowledgments section on page 12 included an incorrect location for one member of the United States Rotavirus Vaccine Efficacy Group, and another member was inadvertently omitted. The correct list should include: Stephen Fries, MD, Boulder Medical Center, Boulder, CO; and Hervey Froehlich, MD, Kaiser Permanente Medical Office, Fresno, CA.

SELF-REPORTED ALLERGY TO THYROID REPLACEMENT THERAPY: A MULTICENTER RETROSPECTIVE CHART REVIEW

2020 ◽  
Vol 26 (7) ◽  
pp. 761-767
Author(s):  
Natalia Chamorro-Pareja ◽  
Ismael Carrillo-Martin ◽  
Daniela A. Haehn ◽  
Sydney A. Westphal ◽  
Miguel A. Park ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Replacement Therapy ◽  
Chart Review ◽  
Case Reports ◽  
Drug Hypersensitivity ◽  
Retrospective Chart Review ◽  
The United States ◽  
Autoimmune Hypothyroidism ◽  
Drug Hypersensitivity Reaction

Objective: To determine patterns of adverse drug reactions (ADRs), including immediate drug hypersensitivity reactions (DHRs) and predictable ADRs, to thyroid replacement therapy (TRT). TRT is the treatment of choice for hypothyroidism. Levothyroxine (LT4) is among the most commonly prescribed medications in the United States, with over 70 million prescriptions annually. Documented immediate DHRs to TRT are rare, with only a few case reports. Methods: An 11-year (2008–2018) retrospective medical chart review of identified patients with self-reported allergy to TRT. ADRs to TRT were divided into immediate DHRs and predictable ADRs. Results: A total of 466 patients were included in our study. We found an overall incidence of ADRs to TRT of 0.3%. Median age was 61.2 years; 85.8% were women, and 94.4% were Caucasian. The principal indication for TRT was autoimmune hypothyroidism (73.6%), followed by postsurgical hypothyroidism (17.4%) and subclinical hypothyroidism (6.7%). Predictable ADR manifestations to TRT were reported more commonly than DHR manifestations (57.5% vs. 42.5%, respectively). The most frequently reported of the former were palpitations (16.4%), nausea/vomiting (9.3%), and tremor (6.3%), while rash (23.8%), hives (9.5%), and pruritus (7.1%) were the most common regarding the latter. Fifty-six percent of the patients with an ADR to TRT tolerated an alternative TRT presentation. Conclusion: In our cohort, the majority of self-reported allergies to TRT were due to predictable ADRs rather than an immediate DHR. Abbreviations: ADR = adverse drug reaction; DHR = drug hypersensitivity reaction; FDA = Food and Drug Administration; LT3 = liothyronine; LT4 = levothyroxine; SCAR = severe cutaneous adverse drug reaction; TRT = thyroid replacement therapy

scholarly journals LB14. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S764-S764 ◽  
Author(s):  
Lee-Jah Chang ◽  
Ya Meng ◽  
Helene Janosczyk ◽  
Victoria Landolfi ◽  
H Keipp Talbot ◽  
...  
Keyword(s):  
United States ◽  
Immune Response ◽  
Influenza Vaccine ◽  
Standard Dose ◽  
The United States ◽  
Influenza Vaccines ◽  
High Dose ◽  
Post Vaccination ◽  
B Lineage ◽  
Research Grant

Abstract Background Older adults (≥65 years of age) remain at increased risk of influenza because they do not respond to standard dose influenza vaccines as well as younger adults. A high dose, inactivated trivalent influenza vaccine, IIV3-HD, containing four times the antigen content (60 µg hemagglutinin per influenza strain) of standard-dose influenza vaccines has been available in the United States since 2010. Two distinct B influenza lineages (Victoria and Yamagata) have co-circulated for over a decade, making it difficult to predict which will predominate the next season. IIV4-HD has been developed to address the frequent influenza B strain mismatches by incorporating a strain from each B lineage. This pivotal Phase III study evaluated the safety and immunogenicity of IIV4-HD as compared with two IIV3-HD vaccines. Method A randomized, modified double-blind, multicenter study (NCT03282240) was conducted in 2670 healthy subjects in the United States, who were randomly assigned to receive IIV4-HD, a licensed IIV3-HD, or an IIV3-HD with the alternate B influenza strain. Using the hemagglutinin inhibition (HAI) assay at baseline and 28 days after vaccination, post-vaccination geometric mean titers and seroconversion rates were measured. Safety data were collected through 6 months post-vaccination. Result IIV4-HD was noninferior to the licensed IIV3-HD and the investigational IIV3-HD (containing the alternate B strain) for all four influenza strains as assessed by HAI GMTs and seroconversion rates. Moreover, IIV4-HD induced a superior immune response (HAI GMTs and seroconversion rates) compared with the immune response induced by the IIV3-HD that does not contain the corresponding B strain. Reactogenicity profiles were comparable across all study groups. Most unsolicited adverse events were of Grade 1 or Grade 2 intensity. One serious adverse event considered related by the Investigator was reported in the IIV4-HD group. Conclusion Vaccination of adults 65 years of age and older with IIV4-HD was found to be noninferior to two IIV3-HD vaccines with a similar safety profile. The addition of a second B lineage strain does not adversely affect the safety or immunogenicity profile of IIV4-HD compared with IIV3-HD. Disclosures L. J. Chang, Sanofi Pasteur: Employee, Salary. Y. Meng, Sanofi Pasteur: Employee, Salary. H. Janosczyk, Sanofi Pasteur: Employee, Salary. V. Landolfi, Sanofi Pasteur: Employee, Salary. H. K. Talbot, Sanofi Pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.

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