Spontaneous Monitoring of Adverse Effects of Drugs in Poland ??? Findings and Conclusions of the Regional Centre for Adverse Drug Reactions Monitoring

Anti-bacterial are agents that inhibit bacterial growth or kills bacteria and are a sub-type of antimicrobials. These are drugs used to treat infections, but they sometimes pose a threat of adverse events. Some of these adverse events are neuropsychiatric, which are generally hard to diagnose and is often paid less attention. They account for about 30% of total Adverse drug reactions (ADRs) caused by drugs in patients without mental abnormalities. The spectrum ranges from episodes of seizure to acute psychosis. The article emphasizes the frequency of such adverse events and means to raise awareness among medical practitioners regarding the same. The various neuropsychiatric adverse effects and the agents responsible have been reviewed, along with their possible mechanisms and general management. The information for writing this review was selected by searching for keywords such as Neurotoxicity, GABA, Psychosis, Naranjo scale, and Antibiomania in databases such as Google Scholar, PubMed, Elsevier, etc. After searching the articles in the above-mentioned databases, the articles were screened concerning their importance with our work and according to their title and abstract. Additional articles were discovered by checking the references in the current study's citations. Using this method, the various neuropsychiatric adverse effects of Antibacterial agents were summarized in this review.

Download Full-text

Alopecia Associated with HMG-CoA Reductase Inhibitor; “Delayed, Recurrent” SIADH and SSRIs; Serious Adverse Effects with Acetazolamide; Tetany Associated with Proton Pump Inhibitor

Hospital Pharmacy ◽

10.1177/001857870203701009 ◽

2002 ◽

Vol 37 (10) ◽

pp. 1040-1042 ◽

Cited By ~ 1

Author(s):

Joel Shuster

Keyword(s):

Proton Pump Inhibitor ◽

Adverse Effects ◽

Adverse Drug Reactions ◽

Proton Pump ◽

Reductase Inhibitor ◽

Drug Reactions ◽

Hmg Coa Reductase ◽

Hmg Coa Reductase Inhibitor ◽

Coa Reductase

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Download Full-text

Drug-induced neurological disease

10.1093/med/9780199568741.003.0240 ◽

2018 ◽

Author(s):

Robin Ferner ◽

Anthony Cox

Keyword(s):

Adverse Drug Reaction ◽

Nervous System ◽

Drug Reaction ◽

Adverse Effects ◽

Adverse Drug Reactions ◽

Neurological Disease ◽

Specific Treatment ◽

Vascular Diseases ◽

Drug Reactions ◽

Drug Induced

An adverse drug reaction is defined as ‘an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product; adverse effects usually predict hazard from future administration and warrant prevention, or specific treatment, or alteration of the dosage regimen, or withdrawal of the product’ (p. 1255, Edwards IR and Aronson JK. Adverse drug reactions: Definitions, diagnosis, and management. Lancet 2000; 356: 1255–9). Adverse drug reactions can cause or contribute to central and peripheral nervous system disorders, including traumatic, infective, neoplastic, demyelinating, and vascular diseases.

Download Full-text

TOXICITIES OF TARGETED THERAPY AND IMMUNE-RELATED ADVERSE DRUG REACTIONS OF IMMUNOTHERAPY IN THE TREATMENT OF METASTATIC MELANOMA

10.5644/pi2019.180.04 ◽

2018 ◽

Author(s):

Lidija Kandolf Sekulović

Keyword(s):

Overall Survival ◽

Targeted Therapy ◽

Side Effects ◽

Adverse Effects ◽

Metastatic Melanoma ◽

Adverse Drug Reactions ◽

Mek Inhibitor ◽

Braf Inhibitors ◽

Drug Reactions ◽

Acneiform Eruption

Targeted therapy and immunotherapy changed the treatment landscape for metastatic melanoma, which is chemotherapy resistant cancer. In pre-innovation era, the overall survival of patients with metastatic melanoma was 6 months, while today 5-year overall survival rate of 34% (and 50% in good prognostic groups) is evident. However, both treatments have their side effects, and cutaneous are the most frequent. Treating physicians in oncology centres, but also primary care specialists, need to be aware of their spectrum which differs for each class of drug: BRAF inhibitors, MEK inhibitors and immunotherapy with anti-PD1 and anti-CTLA4. While BRAF inhibitors have the most prominent adverse effects which are class specific, there are also drug-specific adverse effects. For example, vemurafenib causes photosensitivity, which is not specific for dabrafenib, while dabrafenib induces pyrexia, that occurs much less frequently with other BRAF inhibitors. Cutaneous rash and cutaneous neoplasms which develop due to paradoxical activation of RAS signalling are described with BRAF inhibitor monotherapy. These side-effects are much less common in combination therapy with BRAF and MEK inhibitor, but MEK inhibitor itself causes characteristic acneiform eruption, and serous retinopathy. Immune related adverse drug reactions are a hallmark of the immune checkpoint inhibitor immunotherapy, which can affect every organ system, and most commonly skin, lungs and gastrointestinal system, with differential frequencies recorded with anti-CTLA4 therapy and anti PD-1 therapy. Skin reactions most frequently include pruritus and eczematous reactions, as well as vitiligo-like hypopigmentation, which is linked Melanom 45 to the better response to treatment. In this review, frequent and rare side effects are presented, as well as the current algorithms for their treatment.

Download Full-text

Adverse drug reaction and its management in tuberculosis patients with multidrug resistance: a retrospective study

Journal of Basic and Clinical Physiology and Pharmacology ◽

10.1515/jbcpp-2020-0447 ◽

2021 ◽

Vol 32 (4) ◽

pp. 783-787

Author(s):

Wenny Putri Nilamsari ◽

Muhammad Fajar Rizqi ◽

Natasya Olga Regina ◽

Prastuti Asta Wulaningrum ◽

Umi Fatmawati

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Effects ◽

Adverse Drug Reactions ◽

Multidrug Resistant ◽

Small Samples ◽

Drug Reactions ◽

Outpatient Unit ◽

Resistant Tuberculosis ◽

Mdr Tb

Abstract Objectives This study was conducted to assess adverse drug reactions and their management in MDR-TB patients. Indonesia is the fifth highest country with multidrug-resistant tuberculosis (MDR-TB) high burden around the world. The number of MDR-TB patients in Indonesia is increasing every year, but the data regarding ADRs are still limited. Therefore, more data on their characteristics and their management is very valuable for clinicians and pharmacists. Methods The study is a descriptive study, using retrospective data of MDR-TB patients who completed therapy from January 1st, 2015 to December 31st, 2015 at the Tuberculosis Outpatient unit at the Dr. Soetomo Teaching Hospital Indonesia. Each adverse effect was judged with standards of the clinic and was documented in patients’ medical records. Results There were 40 patients included in this study. During therapy, 70% of patients developed at least one adverse drug reaction. The five most prevalent adverse effects found in this study were hyperuricemia (52.5%) followed by gastrointestinal (GI) disturbances (40%), ototoxicity (37.5%), hypokalemia (27.5%), and athralgia (12.5%). Managements that were undertaken to overcome the adverse drug reactions were adding symptomatic drugs and/or modifying the treatment regimen. Conclusions Because of the small samples we cannot attain a general conclusion. However, the result of this study is very imperative as this data gives us insight regarding adverse effects in MDR-TB patients in Indonesia.

Download Full-text

ADRs Causing Hospital Admissions; A Reader's Tale of Serotonin Syndrome; Adverse Effects of Laxatives; Oxcarbazepine-Induced SIADH; Two Problems with Fluoroquinolones

Hospital Pharmacy ◽

10.1177/001857870203701109 ◽

2002 ◽

Vol 37 (11) ◽

pp. 1143-1146 ◽

Cited By ~ 3

Author(s):

Joel Shuster

Keyword(s):

Adverse Effects ◽

Adverse Drug Reactions ◽

Serotonin Syndrome ◽

Hospital Admissions ◽

Drug Reactions

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

Download Full-text

A pharmacovigilance study of anti-depressant agents in psychiatric patients at a tertiary care teaching hospital

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20201921 ◽

2020 ◽

Vol 8 (5) ◽

pp. 1745

Author(s):

D. Phani Bhushan ◽

R. Hari Babu ◽

J. Rashi ◽

M. Tabitha Satya Suvidha ◽

Mounika Susanthi U. ◽

...

Keyword(s):

Weight Gain ◽

Adverse Effects ◽

Adverse Drug Reactions ◽

Sleep Disturbances ◽

Selective Serotonin Reuptake Inhibitors ◽

Prospective Observational Study ◽

Psychiatric Patients ◽

Tertiary Care ◽

Drug Reactions ◽

Drug Naïve

Background: Anti-depressant drugs have great benefit in treating a many psychiatric disorders, including schizophrenia and bipolar disorder, although all these drugs are associated with many potential adverse effects. In this study, the occurrence of adverse effects like weight gain, sleep disturbances, dry mouth were assessed and reported in drug naïve patients Anti-depressant drugs.Methods: It is a prospective observational study of patients attending Psychiatry department in NRI General Hospital of age 10 to 80 years who were prescribed with anti-depressant drugs. The study was conducted for a period of 8 months from June 2018 to February 2018.Results: Among 86 patients prescribed with antidepressants, the occurrence of adverse drug reactions due to antidepressants was 60.78% with Selective serotonin reuptake inhibitors being the most common class of drugs implicated for adverse drug reactions followed by 24.49% with Tricyclic antidepressants. A total of 51 adverse drug reactions were noted of which weight gain was most common, closely followed by sleep disturbances and drowsiness. Out of 52 adverse drug reactions assessed for causality, 88.2% of the adverse drug reactions cases were probable, while 11.7% were possible. According to Hartwig and Siegel’s Scale 84.3% of the cases are found to be mild, 15.68% moderate.Conclusions: The study allows knowing information about the occurrence and pattern of adverse drug reactions associated with Anti-depressant drugs in the population thus reducing its incidence and protecting the user population from available harm.

Download Full-text

Signal Detection and their Assessment in Pharmacovigilance

Open Pharmaceutical Sciences Journal ◽

10.2174/1874844901502010066 ◽

2015 ◽

Vol 2 (1) ◽

pp. 66-73 ◽

Cited By ~ 1

Author(s):

Anoop Kumar ◽

Henna Khan

Keyword(s):

Adverse Effects ◽

Signal Detection ◽

Adverse Drug Reactions ◽

Current Method ◽

Limited Information ◽

Drug Reactions ◽

Effect Analysis ◽

Specific Patient ◽

Recent Developments ◽

Post Marketing

Signal detection and its assessment is the most important aspect in pharmacovigilance which plays a key role in ensuring that patients receive safe drugs. For detection of adverse drug reactions, clinical trials usually provide limited information as they are conducted under strictly controlled conditions. Some of the adverse drug reactions can be detected only after long term use in larger population and in specific patient groups due to specific concomitant medications or disease. The detection of unknown and unexpected safety signals as early as possible from post marketing data is one of the major challenge of pharmacovigilance. The current method of detecting a signal is predominantly based on spontaneous reporting, which is mainly helpful in detecting type B adverse effects and unusual type A adverse effects. Other sources of signals detection are prescription event monitoring, case control surveillance and follow up studies. Signal assessment is mainly performed by using Upsala Monitoring scale & Naranjo scale of probability to analyze the cause and effect analysis. Signal detection and their assessment is very vital and complex process. Thus, the main objective of this review is to provide a summary of the most common methods of signal detection and their assessment used in pharmacovigilance to confirm the safety of a drug. Recent developments, challenges, & future needs have also been discussed.

Download Full-text

Cutaneous Adverse Drug Reactions / Dematološka neželjena dejstva lekova

Serbian Journal of Dermatology and Venerology ◽

10.2478/v10249-012-0005-8 ◽

2012 ◽

Vol 4 (2) ◽

pp. 61-76

Author(s):

Lidija Kandolf-Sekulović ◽

Tatjana Radević

Keyword(s):

Adverse Effects ◽

Adverse Drug Reactions ◽

Adverse Reactions ◽

Skin Diseases ◽

Clinical Manifestations ◽

Drug Intake ◽

Drug Reactions ◽

Drug Induced ◽

Skin Reactions ◽

Wide Range

Abstract Adverse drug reactions may be defined as undesirable clinical manifestations resulting from administration of a particular drug; this includes reactions due to overdose, predictable side effects, and unanticipated adverse manifestations. Adverse drug effects on the skin are among the most frequent reactions and, according to a study, account for approximately 14% of all adverse drug reactions. However, the incidence of cutaneous adverse effects in general population is unknown. Systemic drug administration results in various cutaneous adverse reactions, and medications used in the treatment of skin diseases themselves have their own adverse effects. Adverse drug reactions include a wide range of effects, from harmless exanthema of short duration, urticaria to systemic cutaneous reactions such as drug rash with eosinophilia and systemic symptoms (DRESS) or toxic epidermal necrolysis. Exanthematous eruptions and urticaria are the two most common forms of cutaneous drug reactions. Less common include fixed eruptions, lichenoid, pustular, bullous and vasculitis reactions. The most severe cutaneous and mucosal adverse drug reactions are epidermal necrolysis, which is usually drug-induced, DRESS syndrome, and acute generalized exanthematous pustulosis. Therefore, the diagnostic of adverse drug reactions requires a detailed history of drug intake and development of skin disorders, excellent knowledge of clinical presentations for a wide range of drug-induced skin reactions as well as of the very medications being taken by patients. In addition to details on drug intake, it is necessary to learn about taking herbal and alternative preparations, which may also cause adverse reactions. A drug started within 6 weeks of the development of disorders is considered the most common cause of adverse reaction, as well as drugs taken periodically but regularly. Once a reaction has occurred, it is important to prevent future similar reactions with the same drug or a cross-reacting medication. Early withdrawal of all potentially responsible drugs is essential, particularly in case of severe drug reactions.

Download Full-text