scholarly journals Retrospective clinical analysis of adverse drug reactions associated with antiretroviral therapy in Tlokwe district, South Africa

2018 ◽  
Vol 60 (1) ◽  
pp. 47
Author(s):  
Rentia Van Graan ◽  
Michelle Viljoen ◽  
Malie Rheeders ◽  
Fadeela Motara
Keyword(s):  
South Africa ◽  
Peripheral Neuropathy ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Final Analysis ◽  
Fat Distribution ◽  
Clinical Analysis ◽  
Drug Reactions ◽  
Healthcare Facilities ◽  
Number Of Patients

Background: South Africa has the highest number of patients on antiretroviral therapy (ART) globally. Various obstacles were identified that influence effective reporting of adverse drug reactions (ADRs) in resource-limited countries. This investigation aimed to identify, classify and analyse the prevalence of ART-related ADRs. Methods: This observational, quantitative and retrospective descriptive investigation utilised ADR forms completed by healthcare professionals in various healthcare facilities in the Tlokwe district, South Africa (January 2010 to December 2014). Descriptive and inferential analyses were carried out. Results: A total of 770 ART-related ADRs were included in the final analysis. The mean age was 40.1 (± 10.1%) years, with significantly higher ADRs reported in females (70.8%). In this study, 99% of the ADRs were reported by doctors. Abnormal fat distribution (58%), peripheral neuropathy (21.6%) and renal dysfunction (6.6%) were most frequently reported. Females presented with abnormal fat distribution and peripheral neuropathy at a significantly younger age (38.1 ± 4.6 vs. 43.4 ± 5.7 years, p < 0.0001 and 39.7 ± 1.1 vs. 45.1 ± 9.2 years, p < 0.001) respectively compared with males. Gender difference was practically significant (Cramer’s V = 0.3) for all three of the major reported ADRs. Conclusions: Gender was highly dependent among the major reported ADR categories, and women presented with abnormal fat distribution and peripheral neuropathy at a significantly earlier age than males. This retrospective analysis can serve as a platform for future ADR studies within this district. Sustainable and continuous efforts should be made to train and create more awareness among healthcare workers in this district. (Full text of the research articles are available online at www.medpharm.tandfonline.com/ojfp) S Afr Fam Pract 2018; DOI: 10.1080/20786190.2017.1364013

scholarly journals Adverse Drug Reactions Among Patients Initiating Second-Line Antiretroviral Therapy in South Africa

Drug Safety ◽  
2018 ◽  
Vol 41 (12) ◽  
pp. 1343-1353 ◽  
Author(s):  
Dorina Onoya ◽  
Kamban Hirasen ◽  
Liudmyla van den Berg ◽  
Jacqui Miot ◽  
Lawrence C. Long ◽  
...  
Keyword(s):  
South Africa ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Second Line ◽  
Drug Reactions ◽  
Second Line Antiretroviral Therapy

Patient's Death Due to Another Case of Glycemic Control Problems with a Fluoroquinolone; Acute MI after OTC Pseudoephedrine Use; Asterixis Related to Gabapentin Results in Patient Falls; Antiseptic Bath Emollient Causes Acute Irritant Reaction to Genitalia; Peripheral Neuropathy with New Antifungal; Debilitating Muscle Cramps after Teriparatide Therapy Psychiatric Effects of Ephedra Use

2005 ◽  
Vol 40 (4) ◽  
pp. 304-308
Author(s):  
Joel Shuster
Keyword(s):  
Peripheral Neuropathy ◽  
Glycemic Control ◽  
Adverse Drug Reactions ◽  
Control Problems ◽  
Drug Reactions ◽  
Muscle Cramps ◽  
Patient Falls ◽  
Acute Mi

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.

Adverse Drug Reactions and Clinical Outcomes in Patients Initiated on Antiretroviral Therapy: A Prospective Cohort Study From Ethiopia

Drug Safety ◽  
2015 ◽  
Vol 38 (7) ◽  
pp. 629-639 ◽  
Author(s):  
Woldesellassie M. Bezabhe ◽  
Luke R. Bereznicki ◽  
Leanne Chalmers ◽  
Peter Gee ◽  
Desalew M. Kassie ◽  
...  
Keyword(s):  
Cohort Study ◽  
Antiretroviral Therapy ◽  
Clinical Outcomes ◽  
Adverse Drug Reactions ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Drug Reactions

The final report of post-marketing surveillance for cetuximab in colorectal cancer in Japan.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 590-590 ◽  
Author(s):  
K. Yamaguchi ◽  
T. Satoh ◽  
T. Watanabe ◽  
M. Ishiguro ◽  
K. Maruyama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Drug Reactions ◽  
Infusion Reaction ◽  
Gastrointestinal Disorders ◽  
Final Report ◽  
Skin Disorders ◽  
Drug Reactions ◽  
Post Marketing Surveillance ◽  
Number Of Patients ◽  
Post Marketing

590 Background: Cetuximab (ERBITUX) was approved in Jul 2008 in Japan with indication for EGFR-positive and unresectable metastatic or refractory colorectal cancer. Post-marketing surveillance is required by Japanese Health Authority to collect, obtain, verify or validate information on the safety, efficacy and quality of medicines. We conducted this surveillance in all patients treated with cetuximab to access in practical use since clinical data on Japanese patients are limited. Methods: The target number of patients was 1,800. Following adverse drug reactions were investigated: infusion reaction, skin disorders, interstitial lung diseases, electrolyte abnormalities (including hypomagnesemia), heart toxicities, gastrointestinal disorders, thrombosis/embolism, delayed wound healing, and eye disorders. Results: Between Sep 2008 until Jan 2010, 2,126 pts registered, 2,006 pts were evaluable for safety (safety population), 1,687 pts for efficacy (efficacy population). Of the 2,006 pts, 1,975 pts (98.5%) were EGFR-positive. Patients characteristics: male/female; 1,234/772 (61.5%/38.5%), median age; 64 (range 18-87), site of primary tumor; colon/rectal/others (multiple selection); 1,235/775/3 (61.6%/38.6%/0.2%), PS0/PS1; 1,370/630 (68.3%/31.4%), combination chemotherapy; cetuximab monotherapy/CPT-11/FOLFIRI: 460/1,255/256 (22.9%/62.56%/12.8%). Of the 2,006 pts, 133 pts (6.6%) and 1,869 pts (93.2%) were treated in second-line and in third-line or later treatment, respectively. The adverse drug reactions incidence was 89.9%. Incidence of skin disorders, gastrointestinal disorders, electrolyte abnormality including hypomagnesaemia, and infusion reaction were 83.7%, 23.1%, 11.5%, and 5.7%, respectively. Efficacy result: Of the 1,687 pts, 658 pts (39.0%) were evaluated to be effective. Of the 658 pts, 614 pts (93.3%) experienced skin adverse reactions. Conclusions: This post-marketing surveillance confirms the safety and efficacy of cetuximab in the Japanese population treated in clinical practice. The outcome of this surveillance with Japanese 2,006 pts would be useful for clinical use of cetuximab. [Table: see text]

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