Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines * Author's reply

Protamine sulphate is routinely used after cardiopulmonary bypass (CPB) to restore the patient’s baseline coagulatory state. However, adverse reactions are encountered, and alternative means to neutralize heparin are, therefore, necessary. The Heparin Removal Device (HRD) constitutes an extracorporeal circuit that allows ex vivo deheparinization by mean of a polycationic ligand that binds heparin molecules. This paper presents the setup of the HRD circuit. It is illustrated by the report of a 68-year-old man with a known severe crustacean allergy. The patient (78 kg, 170 cm) was admitted for elective coronary artery bypass graft surgery. It was decided that the HRD would be used as a precaution in order to avoid the risks of using protamine sulphate. The CPB time and aortic crossclamp time were 70 and 40 min, respectively. At the end of CPB, the device was inserted and processing started. Activated coagulation time values were monitored over a 130 min period and diminished from 480 to 300 s after 45 min, 220 s after 90 min, and settled at 150 s. Haemostasis was acceptable and processing stopped. The operation was terminated and the patient transferred to the intensive care unit. Clinical evolution was excellent, with minimal postoperative bleeding. The HRD presents an alternative to protamine sulphate when this drug is contraindicated for a certain patient population who might have a suspected, known or emergency adverse reaction.

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Reporting adverse reactions: ▾ the black triangle and the patient

Drug and Therapeutics Bulletin ◽

10.1136/dtb.21.24.93 ◽

1983 ◽

Vol 21 (24) ◽

pp. 93-94

Keyword(s):

Adverse Reaction ◽

Adverse Reactions ◽

Data Sheet ◽

British National Formulary ◽

National Formulary ◽

Black Triangle ◽

Suspected Adverse Reaction

The symbol ▾ in the British National Formulary, MIMS, and the Data Sheet Compendium identifies all products introduced during the preceding 2 to 3 years, or in some circumstances longer ago. It informs doctors of the Committee on Safety of Medicines’ particular request for reports of any suspected adverse reaction, however trivial, to such a product. Doctors still make inadequate use of yellow cards. The CSM’s guidelines on what to report are given at the end of this article.

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Sulphasalazine and mesalazine: serious adverse reactions re-evaluated on the basis of suspected adverse reaction reports to the Committee on Safety of Medicines

Gut ◽

10.1136/gut.51.4.536 ◽

2002 ◽

Vol 51 (4) ◽

pp. 536-539 ◽

Cited By ~ 188

Author(s):

R A J Ransford

Keyword(s):

Adverse Reaction ◽

Adverse Reactions ◽

Suspected Adverse Reaction

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A Case of Photodynamic Therapy for Advanced Adenocarcinoma of Esophagogastric Junction

Journal of Clinical and Nursing Research ◽

10.26689/jcnr.v4i6.1620 ◽

2020 ◽

Vol 4 (6) ◽

Author(s):

Wanlu Cai ◽

Xiaoxiong Hu ◽

Jianwen Sheng ◽

Huizhen Fan

Keyword(s):

Adverse Reaction ◽

Photodynamic Therapy ◽

Elderly Patients ◽

Esophagogastric Junction ◽

Adverse Reactions ◽

Clinical Symptoms ◽

Gastric Fundus ◽

High Repetition Rate ◽

Invasive Technique ◽

Short Term

Photodynamic therapy (PDT) is a new minimally invasive technique for the treatment of tumors. Compared with traditional treatments such as surgery, radiotherapy and chemotherapy, PDT has the advantages of targeted killing of primary and recurrent tumor cells, less damage to surrounding normal tissue, less complications and high repetition rate. The purpose of this study was to investigate the short-term efficacy and adverse reactions of photodynamic therapy in advanced elderly patients with esophageal-gastric junction adenocarcinoma without surgical indications. A patient with advanced adenocarcinoma of esophagus and fundus was treated with photodynamic therapy under gastroscope. Intravenous drip of Cipofen (hematoporphyrin injection 150mg / 0.9% saline 250ml) for 1 hour to keep the patient away from light.48 hours after administration, photodynamic therapy was performed with "Leimai" PDT630-A photodynamic therapy apparatus, 3cm columnar optical fiber, laser treatment wavelength of 630nm, transmission efficiency of 0.70, output power of 1.4W, irradiation at the lower segment of the esophagus and cardia for 150s. The curative effect was evaluated by comparing gastroscopy before and after photodynamic therapy. Before treatment, there were proliferative lesions in the lower part of esophagus and cardia, erosion and necrosis on the surface, stricture of esophageal cavity, huge ulcer near gastric fundus, filthy moss and dam-like hyperplasia and eminence of surrounding mucosa. After treatment, the local mucosa at the entrance of cardia became white and there was no bleeding. Within four days after treatment, the symptoms of nausea and vomiting disappeared; the adverse reaction of retrosternal discomfort began to occur on the second day after operation, and the adverse reaction was not improved after photodynamic therapy. Photodynamic therapy has a significant short-term effect on advanced elderly patients with adenocarcinoma of the esophagogastric junction, which can significantly alleviate the clinical symptoms and relieve the pain of the patients. However, the adverse reactions can not be ignored. Therefore, photodynamic targeting therapy for tumor needs to be further studied. It is believed that with the continuous development of high-performance photosensitizers and new generation lasers, and the continuous progress of endoscopy and image guidance technology, photodynamic therapy will become an important adjuvant or palliative treatment for tumor prevention and treatment.

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Apheresis-Adverse Events in Man and Machine Individualities

Faridpur Medical College Journal ◽

10.3329/fmcj.v14i1.46162 ◽

2020 ◽

Vol 14 (1) ◽

pp. 27-30

Author(s):

Md Ashraful Hoque ◽

Kashfia Islam ◽

Selina Akter

Keyword(s):

Adverse Reaction ◽

Adverse Events ◽

Adverse Reactions ◽

Key Factors ◽

Serious Adverse Events ◽

Female Ratio ◽

The Mean ◽

Male To Female ◽

Citrate Toxicity ◽

Common Adverse Reaction

Adverse events due to platelet pheresis are not unheard of citrate related reactions being the most common. Most of these events are mild and self limiting. The current study describes adverse events in platelet pheresis using modern apheresis systems. This prospective study included 1455 platelet pheresis procedures done from July 2016 to December 2017. Procedures were performed on Hemonetics MCS+, Trima Accel and Cobe spectra cell separators. The endpoint of each procedure was a yield of 3 × 1011 platelets (PLTs) per unit. Donor adverse reaction if any was managed, reported, and documented. The median age of donors was 31 years with male to female ratio of 13:1. The median body surface area and body mass index were 1.64 m2 and 22.4 kg/m2, respectively. The mean PLT count of donors was 199.8 × 103/uL with a mean hemoglobin value of 13.6 g/dl. ACD infusion was significantly more in the Hemonetics MCS+, (P< 0.01). Donation time was least with the Trima compared to Hemonetics MCS+ (P< 0.01) and Cobe (P< 0.001). Total whole blood volume processed was higher in Hemonetics MCS+, (P< 0.01). Paresthesia due to citrate toxicity was the most common adverse reaction (65.3%), and vascular injury was observed in only five donors. The overall incidence of adverse reaction was 3.4%. Serious adverse events were not observed. The modern generation apheresis machines are more donors friendly and cause less adverse reactions compared to the older versions. Good donor screening, optimized donor physiognomic and hematological values and skilled operators are the key factors in reaction reduction by apheresis. Faridpur Med. Coll. J. Jan 2019;14(1): 27-30

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Tetracycline Allergy

Pharmacy ◽

10.3390/pharmacy7030104 ◽

2019 ◽

Vol 7 (3) ◽

pp. 104 ◽

Cited By ~ 3

Author(s):

Leslie A. Hamilton ◽

Anthony J. Guarascio

Keyword(s):

Adverse Reaction ◽

Adverse Reactions ◽

Allergic Reactions ◽

Hypersensitivity Reactions ◽

Serious Adverse Events ◽

Tetracycline Antibiotics ◽

Reaction Type ◽

Pubmed Search ◽

Life Threatening ◽

Selection Of

Despite the widespread use of tetracycline antibiotics since the late 1940s, tetracycline hypersensitivity reactions have rarely been described in the literature. A comprehensive PubMed search was performed, including allergic and serious adverse reactions attributed to the tetracyclines class of antibiotics. Of the evaluated tetracycline analogs, minocycline was attributed to the greatest overall number and severity of serious adverse events reported in the literature, with notable reactions primarily reported as respiratory and dermatologic in nature. Reactions to tetracycline have also been well described in the literature, and although dermatologic reactions are typically less severe in comparison with minocycline and doxycycline, various reports of anaphylactic reactions exist. Although doxycycline has been noted to have had the fewest reports of severe allergic reactions, rare descriptions of life-threatening reactions are still reported in the literature. Allergic reactions regarding tetracyclines are rare; however, adverse reaction type, severity, and frequency among different tetracycline analogs is somewhat variable. A consideration of hypersensitivity and adverse reaction incidence should be performed prior to the selection of individual tetracycline entities.

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Adverse reaction profiles of hemorrhagic adverse reactions caused by direct oral anticoagulants analyzed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database

International Journal of Medical Sciences ◽

10.7150/ijms.34629 ◽

2019 ◽

Vol 16 (9) ◽

pp. 1295-1303 ◽

Cited By ~ 1

Author(s):

Kazuyo Shimada ◽

Shiori Hasegawa ◽

Satoshi Nakao ◽

Ririka Mukai ◽

Sayaka Sasaoka ◽

...

Keyword(s):

Adverse Reaction ◽

Adverse Reactions ◽

Reporting System ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Drug Event ◽

Event Report ◽

Event Reporting

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Acute Respiratory Distress Syndrome after Aprotinin Infusion

Annals of Pharmacotherapy ◽

10.1177/106002809703100407 ◽

1997 ◽

Vol 31 (4) ◽

pp. 429-432 ◽

Cited By ~ 12

Author(s):

Zeljko Vucicevic ◽

Tomislav Suskovic

Keyword(s):

Adverse Reaction ◽

Acute Respiratory Distress Syndrome ◽

Respiratory Distress Syndrome ◽

Respiratory Distress ◽

Anaphylactoid Reaction ◽

Adverse Reactions ◽

Distress Syndrome ◽

Ventilatory Support ◽

Allergic Reactions ◽

Case Summary

Objective To report a case of acute respiratory distress syndrome (ARDS) following first exposure to aprotinin. Case Summary A 24-year-old previously healthy white man was treated with aprotinin infusion because of bleeding following tonsillectomy. The patient had never been treated with aprotinin before, including local application of different hemostatics containing the aprotinin component. Two hours later, hypotension and severe ARDS developed. A full recovery was noted after discontinuation of the drug and prolonged ventilatory support. Discussion To our knowledge, this is the first reported case of ARDS following first administration of aprotinin, although serious adverse effects at first exposure have been reported. We propose two possible mechanisms for this adverse reaction: a nonallergic or anaphylactoid reaction with direct degranulation of mast cells and basophils by aprotinin, and microthrombosis of the small pulmonary arterioles precipitated by aprotinin. Conclusions Most clinicians consider aprotinin to be a safe drug, especially if it has not been administered before. Reexposure carries a high risk of allergic reactions because of possible sensitization. Nonimmunologic, toxic, or idiosyncratic adverse reactions can be expected at first exposure to any drug, as well as to aprotinin.

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A Prospective Evaluation of Adverse Reactions to Single-Dose Intravenous Antibiotic Prophylaxis During Outpatient Hand Surgery

Hand ◽

10.1177/1558944718787264 ◽

2018 ◽

Vol 15 (1) ◽

pp. 41-44 ◽

Cited By ~ 1

Author(s):

Kristin Sandrowski ◽

David Edelman ◽

Michael Rivlin ◽

Christopher Jones ◽

Mark Wang ◽

...

Keyword(s):

Adverse Reaction ◽

Single Dose ◽

Antibiotic Prophylaxis ◽

Upper Extremity ◽

Adverse Reactions ◽

Prophylactic Antibiotic ◽

Hand Surgery ◽

Outpatient Setting ◽

Study Cohort ◽

Antibiotic Administration

Background: While it is established that routine prophylactic antibiotics are not needed for all hand surgery, some cases do require it. The purpose of this study was to determine the rate of adverse reactions resulting from prophylactic antibiotic administration on patients undergoing outpatient hand and upper extremity surgical procedures. We hypothesize that the rate of complications resulting from the use of antibiotic prophylaxis is smaller than that reported in the currently referenced literature. Methods: We prospectively evaluated 570 consecutive patients undergoing outpatient upper extremity surgery. Patients were excluded if they were on antibiotics prior to surgery, were discharged on antibiotics, or if they wished to be excluded. Nineteen patients were excluded, resulting in a study cohort of 551 patients. Patients were monitored perioperatively, 2 to 3 days postoperatively, during the first postoperative visit and 1 month postoperatively for adverse reactions. The type and timing of the adverse reaction was recorded. Results: Five hundred fifty-one patients were included for evaluation and 8 patients (1.5%) developed an adverse reaction to antibiotics. Five patients (0.9%) reported a rash and 3 patients (0.5%) reported diarrhea within 3 days of surgery. There were no anaphylactic reactions or complications necessitating hospital transfer or admission in the postoperative period. Conclusion: This study represents a prospective investigation designed to determine the rate of adverse reactions to single-dose antibiotics given during outpatient hand surgery. We conclude that the use of intravenous, single-dose prophylactic antibiotic is safe in the outpatient setting for cases that require it.

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