ADVERSE REACTIONS TO DRUG WITHDRAWAL

Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.

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Adverse Oral Reactions Associated with Low Doses of Methotrexate

Safety and Risk of Pharmacotherapy ◽

10.30895/2312-7821-2020-8-4-205-210 ◽

2020 ◽

Vol 8 (4) ◽

pp. 205-210

Author(s):

N. V. Izmozherova ◽

A. A. Popov ◽

E. F. Gaysina ◽

M. N. Dobrinskaya ◽

V. M. Bakhtin ◽

...

Keyword(s):

Adverse Reactions ◽

Drug Withdrawal ◽

Symptomatic Therapy ◽

Oral Lesions ◽

Low Doses ◽

Pharmacokinetics And Pharmacodynamics ◽

Medical Specialties ◽

Potential Development ◽

Lichenoid Reactions ◽

Drug Pharmacokinetics

Doctors of various medical specialties often encounter adverse drug reactions in their clinical practice. Methotrexate (MTX) can cause adverse reactions in the oral cavity, primarily erosions and ulcerations. The aim of the study was to analyse scientific literature on the prevalence, pathophysiological mechanisms, risk factors for oral lesions associated with low doses of MTX, their prevention and treatment. It was demonstrated that the most frequent oral adverse reactions associated with low doses of MTX are hard-to-heal painful necrotic and often irregularly shaped lesions of the oral mucosa (including aphthae and ulcers). The spectrum of histopathological changes ranges from nonspecific ulcerations to lichenoid reactions. Treatment of oral lesions induced by low doses of MTX consists in drug withdrawal or dose tapering. Folic acid and local symptomatic therapy can also be used, if necessary. Practitioners should be aware of the potential development of MTX-induced oral lesions, and specific aspects of the drug pharmacokinetics and pharmacodynamics in order to be able to ensure timely detection of adverse reactions and their effective treatment.

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Adverse reactions to drug withdrawal

Adverse Drug Reaction Bulletin ◽

10.1097/00012995-199712000-00001 ◽

1997 ◽

Vol 187 (1) ◽

pp. 711-714 ◽

Cited By ~ 5

Author(s):

P A Routledge ◽

M C Bialas

Keyword(s):

Adverse Reactions ◽

Drug Withdrawal

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Evaluation of the efficacy and safety of methotrexate in progressive sarcoidosis: a retrospective observational study

Russian Pulmonology ◽

10.18093/0869-0189-2020-30-2-213-218 ◽

2020 ◽

Vol 30 (2) ◽

pp. 213-218

Author(s):

A. A. Vizel’ ◽

I. Yu. Vizel’ ◽

G. R. Shakirova

Keyword(s):

Observational Study ◽

Adverse Reactions ◽

Drug Withdrawal ◽

Clinical Laboratory ◽

Epithelioid Cell ◽

Retrospective Observational Study ◽

Unknown Etiology ◽

Efficacy And Safety ◽

Line Drug ◽

Treatment Of Sarcoidosis

Sarcoidosis is epithelioid cell granulomatosis of unknown etiology. All the schemes of its treatment are of a recommendatory nature. Methotrexate (MTT) is considered a second-line drug in the treatment of sarcoidosis.Methods. A retrospective observational study of patients with progressive sarcoidosis (n = 104), treated with MTT once a week, was carried out. Clinical, laboratory, functional and radiation parameters were evaluated with an interval of 3 months ≤ 1 year.Results. The use of MTT was accompanied by an improvement in the radiation picture (64.1% by the end of the year), an improvement not only in spirometry parameters, starting from the 3rd month (54.7%), but also in the general condition of the patients (63.8% – at the 6th month). Adverse reactions with drug withdrawal were most often observed (15.4%) during the first 3 months, and subsequently their frequency decreased.Conclusion. According to the results of the study, it was shown that methotrexate can be recommended for further use in progressive sarcoidosis, as well as in patients, who have previously received systemic glucocorticosteroids.

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Drug-induced hyponatremia

Siberian medical review ◽

10.20333/25000136-2021-6-22-34 ◽

2021 ◽

Vol 6 ◽

pp. 22-34

Author(s):

O.D. Ostroumova ◽

◽

A.I. Listratov ◽

A.I. Kochetkov ◽

D.A. Sychev ◽

...

Keyword(s):

Adverse Reactions ◽

Fluid Intake ◽

Drug Withdrawal ◽

Dynamic Monitoring ◽

Electrolyte Disorders ◽

Drug Induced ◽

Treatment And Prevention ◽

Main Culprit ◽

Methods Of Treatment ◽

Analyze Data

Hyponatremia (HN) is one of the most important water-electrolyte disorders in clinical practice. A decrease in sodium levels leads to various complications, including neurological ones. One of the important etiological factors of HN is the intake of a number of drugs. The purpose of the review was to analyze data on those drugs, the intake of which is associated with the development of DI GN, its pathophysiological mechanisms, risk factors, methods of treatment and prevention. The search for the specified keywords was carried out in the databases eLIBRARY.RU, PubMed®, MEDLINE, EMBASE, manuals and methodological recommendations, materials of databases of adverse reactions, instructions for the medical use of drugs in the period from 1971 to 01.07.2021. According to the results obtained, the main culprit drugs include thiazide diuretics, antipsychotic drugs, antidepressants, antiepileptic drugs, antineoplastic drugs. The incidence of HN during the use of antidepressants reaches 40%, with the use of oxcarbazepine occurs in 73.3% of patients. Most often, these drugs lead to HN by the development of a syndrome of inadequate secretion of antidiuretic hormone. During the review, it was found that drugs from a wide variety of groups lead to the development of HN, the mainstay of treatment is drug withdrawal and restriction of fluid intake, and for prevention, dynamic monitoring of sodium levels is required.

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