scholarly journals Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

2020 ◽  
Vol 29 (2) ◽  
pp. 17-26
Author(s):  
Ahmed M. Hameed ◽  
Dheyaa J. Kadhim ◽  
Manal M. Younus
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Subcutaneous Tissue ◽  
Individual Case ◽  
Gastrointestinal Disorders ◽  
Drug Reactions ◽  
Individual Case Safety Report ◽  
Safety Report ◽  
Pharmacovigilance Center

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

scholarly journals Adverse drug reactions of anti-infective drugs for systemic use in Morocco: Pharmaco-Epidemiological study 2008-2016

2021 ◽  
Vol 319 ◽  
pp. 01048
Author(s):  
Donia Kharbouch ◽  
Houda Sefiani ◽  
Zineb Nabih ◽  
Sanou Khô Coulibaly ◽  
Tidiane Diallo ◽  
...  
Keyword(s):  
Sex Ratio ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Subcutaneous Tissue ◽  
Descriptive Study ◽  
Pharmacovigilance System ◽  
Drug Reactions ◽  
Spontaneous Reports ◽  
Pharmacovigilance Center ◽  
Research Period

Analyzing the spontaneous reports of adverse drug reactions (ADRs) of anti-infective drugs for systemic use is an essential pillar in creating valuable database in pharmacovigilance.Therefore, the main of this study is to describe the epidemiological and clinical properties, as well as, the frequency and profile of ADRs generated by anti-infective treatment, declared at the Moroccan Anti-Poison and Pharmacovigilance Center (MAPPC).A retrospective descriptive study was implemented from the notifications of ADRs generated between 2008 and 2016 and recorded on VIGIBASE. Over the research period, 1161 cases of ADRs reports were declared. The average age was 37.4 years ± 19.52, it’s been noticed that the adults were the most affected in 81.89% of the total cases, with the sex ratio (Female / Male) being 1.34. Antimycobacterials and antibacterials for systemic use were responsible for 68% and 28.3% of the adverse reactions, respectively. 29.76% of the cases showcased skin and subcutaneous tissue disorders and 23.23% of the cases displayed hepatobiliary and pancreatic system disorders. Serious cases represented 30% of all noted cases, including 2 fatalities. In the interest of preventing the risk of adverse reactions originating from the taking anti-infective drugs for systemic use, reporting to the ADRs to the pharmacovigilance system should be highly encouraged.

scholarly journals Adverse drug reactions to antibiotics collected by a pharmacovigilance center in Korea: an eight-year retrospective study

2018 ◽  
Vol 141 (2) ◽  
pp. AB87
Author(s):  
Young-Min Ye ◽  
Seung-Kwan Lim ◽  
Young-Wha Choi ◽  
So-Hee Lee ◽  
Ji-Ho Lee ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
Drug Reactions ◽  
Pharmacovigilance Center

scholarly journals Gender Differences in Adverse Drug Reactions Among Adult Patients Reported to the Iraqi Pharmacovigilance Center

2021 ◽  
Vol 30 (2) ◽  
pp. 249-260
Author(s):  
Areej Atheer Alsaedi ◽  
Dheyaa j. Kadhim ◽  
Manal M. Younus
Keyword(s):  
Gender Differences ◽  
Adverse Drug Reactions ◽  
Subcutaneous Tissue ◽  
Fatal Outcome ◽  
Age Groups ◽  
Reproductive Age ◽  
Adult Males ◽  
Drug Reactions ◽  
Significant Difference ◽  
Pharmacovigilance Center

For many years it was argued that there may be a gender differences in adverse drug reactions (ADRs). This assumption was based on many possible factors such as hormonal or behavior differences, and it was not clearly identified since the female gender was not preferred to be enrolled in many clinical trials. The primary aim of this study was to assess the extent of possibly relevant gender differences in drug–ADRs regarding causality, severity, preventability, seriousness, expectedness and outcome. While the secondary aim was to assess for which group of drugs and for which ADRs gender differences are identified most often. The study was a retrospective one that depends on processing a specially selected group of data obtained from the Iraqi Pharmacovigilance Center database. The data included consisted of 3833 individual case safety reports sent during the period from 1st January 2017 to 31st December 2019. It was found that the reported adverse drug reactions for females (60.84 %) were much more than males (39.16 %). In addition, significant differences in age group distribution of adverse drug reactions were found in which females in their reproductive age had more adverse drug reactions while the older adult males were more likely to suffer adverse drug reactions if compared with the same age groups from the opposite gender. The highest type of adverse drug reactions for both genders were those that fall in the skin and subcutaneous tissue disorders (26.4 % in females) and (22.6 % in males) with statically significant difference between the two genders. While the highest group to cause adverse drug reactions was the systemic anti-infective agents with a greater chance ‘statistically significant’ in females to suffer a side effect from this group of medications (40.8 %) compared to male gender (35.5 %). The frequency of serious adverse drug reactions was significantly more prevalent in females (45.4 %) than for males (41.3 %) while the fatal outcome was significantly more observed in males (0.8 %) as compared with females (0.2 %). The expectedness analysis gave the finding that for each gender the expectedness of adverse drug reactions was nearly equal.

scholarly journals Should Levetiracetam Replace Phenytoin for Seizure Prophylaxis after Neurosurgery?

2009 ◽  
Vol 9 (3) ◽  
pp. 71-72 ◽  
Author(s):  
Nathan B. Fountain
Keyword(s):  
Retrospective Study ◽  
Antiepileptic Drugs ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Retention Rate ◽  
Low Risk ◽  
Control Group ◽  
Drug Reactions ◽  
Moderate Risk ◽  
Seizure Prophylaxis

Efficacy and Tolerability of Levetiracetam versus Phenytoin after Supratentorial Neurosurgery. Milligan TA, Hurwitz S, Bromfield EB. Neurology 2008;71(9):665–669. BACKGROUND: Antiepileptic drugs are routinely given after craniotomy. Though phenytoin (PHT) is still the most commonly used agent, levetiracetam (LEV) is increasingly administered for this purpose. This retrospective study compared the use of LEV and PHT as monotherapy prophylaxis following supratentorial neurosurgery. METHODS: Patients receiving LEV monotherapy after supratentorial craniotomy were reviewed and compared to a control group of patients receiving PHT monotherapy. RESULTS: One of 105 patients taking LEV and 9/210 patients taking PHT had seizures within 7 days of surgery ( p = 0.17). Adverse drug reactions requiring change in therapy during hospitalization occurred in 1/105 patients taking LEV and 38/210 patients taking PHT ( p < 0.001). Among patients followed for at least 12 months, 11/42 (26%) treated with LEV vs 42/117 (36%) treated with PHT developed epilepsy ( p = 0.34); 64% remained on LEV, while 26% remained on PHT ( p = 0.03). CONCLUSIONS: Both levetiracetam (LEV) and phenytoin (PHT) were associated with a low risk of early postoperative seizures and a moderate risk of later epilepsy. LEV was associated with significantly fewer early adverse reactions than PHT and with a higher retention rate in patients who were followed for at least 1 year and developed epilepsy.

Adverse Drug Reactions to Radiographic Contrast Media in a Teaching Hospital in North India: An Observational Study

2019 ◽  
Vol 14 (2) ◽  
pp. 122-126
Author(s):  
Deepti Chopra ◽  
Abhinav Jain ◽  
Richa Garg ◽  
Shreya Dhingra
Keyword(s):  
Observational Study ◽  
Contrast Media ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Adverse Reactions ◽  
North India ◽  
Drug Reactions ◽  
Iodinated Contrast ◽  
Radiographic Contrast ◽  
Radiographic Contrast Media

Background: Radiocontrast media are used extensively nowadays to visualize internal organs. Currently, non-ionic iodinated contrast media are used which are generally considered to be safe but some adverse reactions have been reported. Thus, the present study was carried out to analyze the nature and incidence of adverse drug reactions (ADRs) to radiographic contrast media in a teaching hospital. Methods:An observational study carried out for a period of six months in a teaching hospital. Contrast media induced adverse reactions were analyzed in terms of affected organs, rate, causality assessment, severity and preventability. The treatment and outcomes of adverse events were also recorded. Naranjo Probability Scale was used to evaluate the relationship between the contrast agent used and the suspected ADR. The severity of the suspected ADRs was determined using Hartwig Scale and preventability was assessed using modified Schumock and Thornton criterion. Results:A total of 15 suspected ADRs occurred in 11 patients with an incidence of 1.4%. It included 5 (45.4%) males and 6 (54.5%) females (p < 05). The highest percentage (72.7 %) of ADRs was seen in adult patients, the mean age being 40.8 years. Vomiting (33.3%) was the most common ADR noted followed by severe nausea and rashes. 64.7 % of ADRs were categorized as probable and 35.3 % were possible. Adverse reactions required treatment in 46.6% patients. There was no fatality reported. Conclusion:The reactions observed were mild to moderate in severity and occurred within 30 minutes of the administration of the contrast.

Pharmacovigilence practice for safety of medication system in India

2018 ◽  
Vol 7 (2) ◽  
pp. 216-221
Author(s):  
Shobharam Sahu ◽  
◽  
Poonam Rishishwar ◽  
Chhaya Rathod ◽  
◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
India Institute ◽  
Family Welfare ◽  
New Delhi ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Ministry Of Health ◽  
Regulatory Authorities ◽  
Pharmacovigilance Center ◽  
Uppsala Monitoring

Pharmacovigilance is very essential tool to ensure the safety of drug. It provides safety to patients in case of medication. Activity of pharmacovigilance is coordinates by National pharmacovigilance center in collaboration with international regulatory authorities (WHO, The Uppsala Monitoring center). Under the aegis of Ministry of Health & Family Welfare, Government of India, the Central Drugs Standard Control Organisation (CDSCO), New Delhi, has initiated a nation-wide pharmacovigilance programme, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR)

scholarly journals The Wonderful DMARD with Multiple Toxicities

2021 ◽  
Vol 5 (7) ◽  
pp. RV5-RV10
Author(s):  
Yashika Kaushal ◽  
Ratibha Kausal ◽  
Isha Sharma
Keyword(s):  
Immune System ◽  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Close Monitoring ◽  
Drug Reactions ◽  
Therapy Discontinuation ◽  
Chemotherapy Agent ◽  
Reduce Activity ◽  
Potential Risk Factors ◽  
Rheumatic Drug

Methotrexate is a type of disease-modifying anti-rheumatic drug (DMARD). It is used to reduce activity of the immune system for people who have certain conditions. Methotrexate is a chemotherapy agent and immune system suppressant. Its use may be limited by concerns regarding its adverse reactions. The occurrence of adverse drug reactions in some cases leads to the therapy discontinuation. Although adverse drug reactions (ADR) of methotrexate generally do not pose a serious threat to the health of patients and a reduction in the dose of methotrexate leads to their elimination, in some cases severe toxicities of the drug occur unpredictably. These facts explain the need for close monitoring of the patient’s condition and the identification of potential risk factors for drug toxicity on the part of different organs and functional systems. The purpose of this review is to detail about safety and tolerability of methotrexate.

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

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