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

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%).

Download Full-text

Pharmacovigilence practice for safety of medication system in India

The Journal of Phytopharmacology ◽

10.31254/phyto.2018.7220 ◽

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)

Download Full-text

Common Causes and Characteristics of Adverse Drug Reactions in Older Adults: A Retrospective Study

10.21203/rs.3.rs-58795/v3 ◽

2020 ◽

Author(s):

Seong-Dae Woo ◽

Jiwon Yoon ◽

Go-Eun Doo ◽

Youjin Park ◽

Youngsoo Lee ◽

...

Keyword(s):

Older Adults ◽

Adverse Drug Reactions ◽

Drug Reactions ◽

Younger Patients ◽

Iodinated Contrast ◽

Common Causes ◽

Aging Populations ◽

Pharmacovigilance Center ◽

Inflammatory Drugs ◽

Rate Ratios

Abstract Background: Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥65 years) in comparison to younger individuals (<65 years). Methods: Of 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. We estimated the number of ADRs per 1,000 patients exposed to the major culprit drugs, and incidence rate ratios were obtained to assess high- and low-risk medications in older adults. Results: In total, 4,152 (22.0%) ADRs were reported for 3,437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21-1.44; P <0.001) and fentanyl (1.49, 1.16-1.92, P =0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30-0.40, P <0.001) and iodinated contrast media (ICM) (0.82, 0.76-0.89, P <0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48-3.15; P <0.001) and ICM (2.09, 1.36-3.21, P= 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P =0.019). Conclusion: For early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.

Download Full-text

Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01135-20 ◽

2020 ◽

Author(s):

A. J. Berenstein ◽

N. Falk ◽

G. Moscatelli ◽

S. Moroni ◽

N. González ◽

...

Keyword(s):

Retrospective Study ◽

Adverse Events ◽

Chagas Disease ◽

Adverse Drug Reactions ◽

Drug Tolerance ◽

Drug Reactions ◽

Safety Concerns ◽

Scarce Data

BACKGROUND: Nifurtimox (NF) is one of the only two drugs currently available for Chagas disease (ChD) treatment. However, there is scarce data on NF safety, and many physicians defer or refuse NF treatment because of concerns about drug tolerance. METHODS: Retrospective study of adverse drug reactions (ADRs) associated with NF treatment of ChD. Children received NF doses of 10-15 mg/kg/day for 60-90 days, and adults 8-10 mg/kg/day for 30 days. Results: 215 children (median age: 2.6yrs, range 0-17) and 105 adults (median age: 34yrs, range 18-57) were enrolled. Overall, 127/320 (39.7%) patients developed ADRs, with an incidence of 64/105 in adults, and 63/215 in children (OR = 3.7, 95%CI [2.2;6.3]). We observed 215 ADRs, 131 in adults (median: 2 events/patient (IQR25-75= 1-3) and 84 in children (median: 1 event/patient (IQR25-75= 1-1.5) (PAdjusted < 0.001). ADRs were mainly mild and moderate. Severe ADRs were infrequent (1.2% in children and 0.9% in adults). Nutritional, central nervous and digestive systems were the most frequently affected, without differences between both groups. Treatment was discontinued in 31/320 (9.7%) patients without differences between groups. However, ADR-related discontinuations occurred more frequently in adults than in children (OR = 5.5, 95%CI = [1.5;24]). CONCLUSIONS: Our study supports the safety of NF for ChD treatment. Delaying NF treatment due to safety concerns does not seem to be supported by the evidence.

Download Full-text

Pattern of adverse drug reactions reported to the regional Pharmacovigilance center at Nepal Medical College and Teaching Hospital, Kathmandu

Journal of Nepal Pharmaceutical Association ◽

10.3126/jnpa.v26i1.6633 ◽

2012 ◽

Vol 26 (1) ◽

pp. 54-61 ◽

Cited By ~ 1

Author(s):

Durga Bista ◽

Bal Ram Shrestha ◽

Prakash Rai ◽

Akhilesh Chandra Jauhari ◽

Vishnu Kant Kulshrestha

Keyword(s):

Adverse Drug Reactions ◽

Teaching Hospital ◽

Causality Assessment ◽

Age Group ◽

Drug Reactions ◽

Preliminary Stage ◽

Medical College ◽

Probable Relationship ◽

Pharmacovigilance Center ◽

Inflammatory Drugs

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61

Download Full-text