Adverse drug reaction processing in the United States and its dependence on physician reporting: Zomepirac (Zomax®) as a case in point

1988 ◽  
Vol 17 (2) ◽  
pp. 145-149 ◽  
Author(s):  
Kenneth A Corre ◽  
Theodore E Spielberg
Keyword(s):  
United States ◽  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
The United States ◽  
Reaction Processing

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.

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

Correlative microscopy in distrubuted (client/server) computing environments: tools for catalyzing the rapid dissemination of information about the cell biology of the human prostate

1995 ◽  
Vol 53 ◽  
pp. 682-683
Author(s):  
A. Hakam ◽  
J.T. Gau ◽  
M.L. Grove ◽  
B.A. Evans ◽  
M. Shuman ◽  
...  
Keyword(s):  
United States ◽  
Cell Biology ◽  
Tissue Bank ◽  
The United States ◽  
Prostate Adenocarcinoma ◽  
Correlative Microscopy ◽  
Client Server ◽  
Critical Elements ◽  
Transplant Organ

Prostate adenocarcinoma is the most common malignant tumor of men in the United States and is the third leading cause of death in men. Despite attempts at early detection, there will be 244,000 new cases and 44,000 deaths from the disease in the United States in 1995. Therapeutic progress against this disease is hindered by an incomplete understanding of prostate epithelial cell biology, the availability of human tissues for in vitro experimentation, slow dissemination of information between prostate cancer research teams and the increasing pressure to “ stretch” research dollars at the same time staff reductions are occurring.To meet these challenges, we have used the correlative microscopy (CM) and client/server (C/S) computing to increase productivity while decreasing costs. Critical elements of our program are as follows:1) Establishing the Western Pennsylvania Genitourinary (GU) Tissue Bank which includes >100 prostates from patients with prostate adenocarcinoma as well as >20 normal prostates from transplant organ donors.

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