Adverse Drug Reaction Labelling for Atomoxetine, Methylphenidate and Modafinil: Comparison of Product Information for Oral Formulations in Australia, Denmark and the United States

2013 ◽  
Vol 8 (3) ◽  
pp. 162-168 ◽  
Author(s):  
Lise Aagaard ◽  
Ebba Hansen
Keyword(s):  
United States ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Product Information ◽  
The United States ◽  
Oral Formulations

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 Hypersensitivity reactions to intravenous ferric carboxymaltose in a patient with iron deficiency anemia: a rare case report

2018 ◽  
Vol 7 (5) ◽  
pp. 1036
Author(s):  
Shadma H. Quazi ◽  
Sushil K. Varma ◽  
Sharjeel H. Khan ◽  
Sonali S. Kirde ◽  
Harshada Arun Bhoware
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Poor Response ◽  
The United States ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Hypersensitivity Reactions ◽  
Rare Case Report

Ferric carboxymaltose (FCM) is a non-dextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or poor response to oral iron therapy. Acute hypersensitivity reactions (HSRs) during iron infusions are very rare but can be life-threatening. Adverse events, including immune system disorders (0% in FCM) and skin disorders (7.3% in FCM), are less frequently observed with FCM. On treatment with FCM, the change in hemoglobin from baseline to the highest observed level is about 2.8g/dL. Treatment of IDA with FCM resulted in fewer hypersensitivity reactions. Here, authors report a case of a 23 years old female diagnosed for IDA presented with the picture of adverse drug reaction due to injection FCM given by the physician. The patient was managed with Antibiotics, Corticosteroids and Intravenous fluids and recovered well within 12 hours of admission from this adverse drug reaction. Since such cases have been rarely reported, authors are intended to notify about this potentially dangerous drug reaction due to FCM which is used extensively in the treatment of IDA. Hence management of iron infusions requires very careful and precise observation, and, in the event of an adverse reaction, prompt recognition and severity-related interventions by well-trained medical and nursing staff.

Consumer Information Policy in Sweden—What can be Learned?

1971 ◽  
Vol 35 (1) ◽  
pp. 50-55 ◽  
Author(s):  
Hans B. Thorelli
Keyword(s):  
United States ◽  
Information System ◽  
Product Information ◽  
The United States ◽  
Information Policy ◽  
Consumer Information ◽  
Western Nations ◽  
Almost All ◽  
Labeling System

Almost all Western nations now have private or public consumer information programs. Sweden has a particularly rich experience in the product information area. In this article special emphasis is placed on Sweden's voluntary informative-labeling system which is relatively unknown in the United States. The author suggests that the consumer-conscious U.S. industry might well consider developing a similar consumer information system.

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.

Adverse Drug Reaction Deaths Reported in United States Vital Statistics, 1999-2006

2012 ◽  
Vol 46 (2) ◽  
pp. 169-175 ◽  
Author(s):  
G. Shepherd ◽  
P. Mohorn ◽  
K. Yacoub ◽  
D. W. May
Keyword(s):  
United States ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Vital Statistics

The Role of Vision in Ladislav Sutnar and Knud Lönberg-Holm's Designing Information

Design Issues ◽  
2019 ◽  
Vol 35 (3) ◽  
pp. 3-19
Author(s):  
Hannah Pivo
Keyword(s):  
United States ◽  
Visual Communication ◽  
Product Information ◽  
The United States ◽  
American Business ◽  
Visual Education ◽  
Visual Flow

In 1947, Czech designer Ladislav Sutnar and Danish architect Knud Lönberg-Holm published three articles in Interiors magazine introducing their theories of modern visual communication to the professional design community in the United States. These articles, subsequently released together as Designing Information, were informed by the authors’ work at Sweet's Catalog Service, a dominant publisher of industrial catalogs at the time. At Sweet's, Lönberg-Holm and Sutnar developed standards for product information centered on the concept of “visual flow.” This article examines vision and flow in Designing Information, analyzing how the authors applied ideas from diverse realms of midcentury discourse—including visual education, Gestalt, and Behaviorist psychologies—to the context of American business and industry.

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