Investigation of the Frequency of Adverse Effects in Patients Treated with Favipiravir as SARS-CoV-2 Treatment

Objective: For 2019 and 2020, SARS-CoV-2 has been a sensational virus. Unfortunately, a treatment agent specific for SARS-CoV-2 has not been developed yet. Favipiravir is one of the antiviral agents used experimentally in the treatment of SARS-CoV-2. This study aimed to determine the frequency of side effects seen in patients hospitalized in our hospital and received favipiravir at any stage of their treatment. Methods: Our study is a retrospective observational study. Definite and probable COVID-19 cases hospitalized in our hospital between March 23, 2020, May 31, 2020, were determined, and those receiving favipiravir as initial or secondary therapy were included in the study. The demographic data, laboratory tests, observed side effects of the patients were recorded and analyzed statistically. Results: A total of 134 patients, 37.3% using favipiravir at the beginning and 62.7% as secondary, were included in the study. The mean age of the patients was 66.8±15.7 years. 38.1% (n=51) of the group were female. Side effects were detected in 17 (13%) patients in the whole group. Hepatotoxicity (4.5%), increased serum uric acid (4.5%), nephrotoxicity (1.5%), gastrointestinal side effects (1.5%), cardiac side effects (0.7%) were detected. There was no statistically significant difference in terms of adverse events between the patients who received favipiravir initially or later on disease course. Conclusions: Although some results support the short-term safety of favipiravir, more studies are needed for its long-term effects. Studies on hyperuricemia, QTc prolongation, use in pregnancy, use during lactation and use in children are insufficient. Therefore, although Favipiravir appears to be a good alternative in the treatment of COVID-19, it should be used carefully because the data on its safety is still insufficient. Key Words: Favipiravir, adverse effects, COVID-19, SARS-CoV-2

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Investigation of the Frequency of Adverse Effects in Patients Treated with Favipiravir as SARS-CoV-2 Treatment

Klimik Dergisi/Klimik Journal ◽

10.36519/2021.3563 ◽

2021 ◽

pp. 1-4

Author(s):

Ebru Dogan ◽

Sevil Alkan Çeviker ◽

Servan Vurucu ◽

Alper Sener ◽

Buse Yuksel ◽

...

Keyword(s):

Side Effects ◽

Demographic Data ◽

Antiviral Agents ◽

Good Alternative ◽

Long Term Effects ◽

Cardiac Side Effects ◽

Significant Difference ◽

Gastrointestinal Side Effects ◽

Treatment Agent

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Safety of transdermal fentanyl (TF) in front-line approach to severe cancer pain. Meta-analysis of randomized clinical trials

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19627 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19627-19627

Author(s):

M. Maltoni ◽

E. Scarpi ◽

B. Poggi ◽

D. Tassinari

Keyword(s):

Side Effects ◽

Adverse Effects ◽

Cancer Pain ◽

Safety Profile ◽

Mesh Term ◽

Phase Iii ◽

Front Line ◽

Significant Difference ◽

Opioid Administration ◽

Gastrointestinal Side Effects

19627 Background: To assess the safety of TF when compared with Slow Releasing Oral Morphine (SROM) in the front-line approach to severe cancer pain. Methods: A systematic review of literature in the MEDLINE and EMBASE data bases from 1966 to October 2006, using “Administration, Cutaneous” [MeSH term], “Administration, Oral” [MeSH term], “Analgesic, Opioid/*administration & dosage/adverse effects” [MeSH term], “Delayed-Action Preparations” [MeSH term], “Fentanyl/*administration & dosage/adverse effects” [MeSH term], “Cancer Pain/*drug therapy” [MeSH term], “Morphine/*administration & dosage/adverse effects” [MeSH term] as search terms was performed independently by two authors (DT and MM). All the randomized phase III trials comparing TF and SROM were considered eligible and included into the analysis. The overall side effects odds ratio (OR) was the primary end point of the analysis; overall gastrointestinal side effects, constipation, nausea, somnolence, the patient's preference and the trial withdrawal pooled ORs the secondary ones. Heterogeneity between the trials was analysed using the Mantel-Haenszel test, and the outcome analysis was performed using a fixed effects model and an alpha error lower than 5%. Results: 3 trials met the selection criteria and were included into the analysis. The safety of TF and SROM was analysed in 373 patients (188 and 185 respectively treated with TF and SROM). A significant difference in favour of TF was observed for constipation (OR=0.42, p=0.002), somnolence (OR=0.559, p=0.018) and the preference of the patient (OR=0.39, p<0.001): no significant differences were observed for overall side effects (OR=0.82, p=0.51), overall gastrointestinal side effects (OR=0.87, p=0.6), nausea (OR=1.2, p=0.446) and trial withdrawal (OR=0.62, p=0.59). No heterogeneity was documented between the trials. Conclusion: Although no differences exist between TF and SROM in efficacy (with equianalgesic doses) and safety (when assessed as overall safety profile) on the whole, the differences in the peculiar safety profile of the two opiates seems to favour TF in patient's preference in the choice of front-line treatment of severe cancer pain. No significant financial relationships to disclose.

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The Effect of Systemic Methotrexate and Cyclosporine Combination Therapy inPsoriasis Vulgaris Patients in Bandung, Indonesia

Berkala Ilmu Kesehatan Kulit dan Kelamin ◽

10.20473/bikk.v33.3.2021.200-204 ◽

2021 ◽

Vol 33 (3) ◽

pp. 200

Author(s):

Oki Suwarsa ◽

Fatima Aulia Khairani ◽

Syawalika Ulya Isneny ◽

Erda Avriyanti ◽

Hartati Purbo Dharmadji ◽

...

Keyword(s):

Retrospective Study ◽

Side Effects ◽

Adverse Effects ◽

Combination Therapy ◽

Combination Treatment ◽

Psoriasis Vulgaris ◽

Severity Index ◽

Dermatology Clinic ◽

Significant Difference ◽

Pasi Score

Background: Methotrexate (MTX) and cyclosporine have been used as effective systemic mono-therapy for psoriasis. Several factors are considered to switch monotherapy to combination therapy because monotherapy is no longer effective and has higher side effects. Hence,clinicians have avoided systemic therapy combinations due to its toxicity. However, some studies showed that this combination therapy could be usedeffectively for psoriasis patients. Purpose: This study aimed to analyze the efficacy and adverse effects of systemic MTX and cyclosporine combination therapy in Indonesian psoriasis vulgaris patients. Methods: The retrospective study assessed the effectiveness of 3 monthsmono-therapyand combination therapy of systemic MTX and cyclosporine in psoriasisvulgaris patients from 2016–2017 in Dermatology Clinic, Dr. Hasan Sadikin Hospital, Bandung, West Java, Indonesia. Result: Psoriasis area and severity index (PASI) score 90 were achieved in the group MTX (50%) and cyclosporine group (50%), while none in the combination group.However, eight patients (50%) in group MTX and cyclosporine reached the primary endpoint of PASI 50. One patient in cyclosporine group had adverse effects on kidney profiles. Nonetheless, other patients had no biochemical changes. But, there was no significant difference in the change of PASI between each group (p=0.102). Conclusion: We propose that combination therapy of MTX and cyclosporine is relatively safe and efficacious in treating Indonesian psoriasis vulgaris patients. This combination treatment isas effective as MTX or cyclosporinemono-therapy.

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Treatment with intravenous pamidronate is a good alternative in case of gastrointestinal side effects or contraindications for oral bisphosphonates

BMC Musculoskeletal Disorders ◽

10.1186/1471-2474-10-86 ◽

2009 ◽

Vol 10 (1) ◽

Cited By ~ 4

Author(s):

Danielle A Eekman ◽

Marijn Vis ◽

Irene EM Bultink ◽

Harm JGM Derikx ◽

Ben AC Dijkmans ◽

...

Keyword(s):

Side Effects ◽

Good Alternative ◽

Oral Bisphosphonates ◽

Intravenous Pamidronate ◽

Gastrointestinal Side Effects

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Extended Field Postoperative Radiotherapy (EFRT) Yields better Outcomes as Compared to Localised Field RT (LFRT) in Radically Resected Gallbladder Cancer (GBC)

Asian Pacific Journal of Cancer Care ◽

10.31557/apjcc.2020.5.4.287-293 ◽

2020 ◽

Vol 5 (4) ◽

pp. 287-293

Author(s):

Sushma Agrawal ◽

Rajan Saxena

Keyword(s):

Side Effects ◽

Lymph Nodes ◽

Survival Data ◽

Postoperative Radiotherapy ◽

Demographic Data ◽

Disease Free Survival ◽

Concurrent Chemotherapy ◽

Resection Margins ◽

Significant Difference ◽

Extended Field

Background: Postoperative adjuvant RT is recommended in node positive and positive resection margins patients after radical surgery (RS) in GBC. However there are no guidelines to suggest the regions to be irradiated. Our aim is to compare whether EFRT or LFRT improves outcomes. Methods and Materials: Records of GBC patients who underwent adjuvant chemo-radiotherapy after RS, between January 2007 and December 2014 were reviewed. Demographic data, histopathological data, target delineation, RT treatment planning details, concurrent chemotherapy, side-effects of treatment, and survival data were collated. Patients were treated with either of two techniques: Localised field RT [LFRT] [from 2007-2010] or Extended field RT [EFRT] [from 2011-2014] along with concurrent 5-FU/capecitabine. LFRT involved RT to GB bed, peri-portal, common hepatic artery (CHA) and coeliac lymph nodes and EFRT involved RT to GB bed, peri-portal, CHA, coeliac, gastro-duodenal, superior mesenteric and para aortic lymph nodes. The RT dose was 50.4 Gy/28fractions/5.5 weeks. Loco-regional recurrence rate (LRR), Overall (OS) and Disease free Survival (DFS) was computed with Kaplan Meier method.Results: Out of 60 patients reviewed, 30 were treated with EFRT and 30 with LFRT. There was no significant difference in the acute and late side-effects between the two techniques. At a median follow-up of 44 months (range 36-120 months), 37.5 % patients developed LRR (13.3 % vs 40% in EFRT and LFRT, p = NS).The median OS was not reached (NR) vs 42 months and the median DFS was NR vs 30 months in EFRT vs LFRT respectively (p=0.01 and 0.016). The 5 year OS was 80% vs 42% and 5 year DFS was 80% vs 40% for EFRT and LFRT respectively (p=0.01 and 0.016). Conclusions: Based on our findings, we conclude that EFRT reduces LRR and improves survival in patients with absence of lymphovascular space invasion (LVI) and perineural invasion (PNI). This observation is hypothesis generating and merits validation in a randomised study.

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Risk of infectious, hematological, and gastrointestinal side effects in patients treatedwith ibrutinib: A systematic review and meta-analysis of randomized controlled trials.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18265 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18265-e18265

Author(s):

Myo Zaw ◽

Kyaw Zin Thein ◽

Aung Tun ◽

Lukman Tijani ◽

Elizabeth Guevara

Keyword(s):

Systematic Review ◽

Side Effects ◽

Adverse Effects ◽

Randomized Controlled Trials ◽

Chemokine Receptors ◽

Meta Analysis ◽

Controlled Trials ◽

High Grade ◽

Randomized Controlled ◽

Gastrointestinal Side Effects

e18265 Background: Bruton’s tyrosine kinase (BTK) is essential for signaling of B-cell and chemokine receptors. Ibrutinib targets BTK and has become frontier in many hematologic malignancies. We undertook systematic review and pooled analysis of randomized controlled trials (RCTs) to determine infectious, hematological and gastrointestinal risks associated with ibrutinib. Methods: We performed a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts through December 31, 2016. The RCTs that mention infectious, hematological and gastrointestinal side effects as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio with 95% confidence interval (CI). Results: Four RCTs with a total of 1505 patients were eligible for the analysis. Studies compared Ibrutinib (I) vs ofatumumab, I vs chlorambucil, I+ bendamustine (B)+ rituximab (R) vs placebo + B+ R and I vs temsirolimus were included in the analysis. The relative risks (RR) of all-grade side effects were as follows: infection, 1.34 (95% CI: 1.04 – 1.74; p = 0.02); pneumonia, 1.16 (95% CI: 0.82–1.66; p = 0.38); anemia, 0.77 (95% CI: 0.64 – 0.93; p = 0.007); neutropenia, 0.99 (95% CI: 0.87 – 1.14; p = 0.98); thrombocytopenia, 0.86 (95% CI: 0.71 – 1.04; p = 0.12); diarrhea, 1.74 (95% CI: 1.48 – 2.05; p < 0.0001); nausea, 0.94 (95% CI: 0.80 – 1.10; p = 0.45); and vomiting, 0.98 (95% CI 0.74 – 1.30; p = 0.93). The RR of high-grade adverse effects were as follows: febrile neutropenia, 1.32 (95% CI: 0.84 – 2.08; p = 0.21); infection, 1.20 (95% CI: 0.73 – 1.98; p = 0.45); pneumonia, 1.22 (95% CI: 0.76–1.95; p = 0.39); anemia, 0.48 (95% CI: 0.33 – 0.71; p < 0.0001); neutropenia, 0.99 (95% CI: 0.86 – 1.15; p = 0.94); thrombocytopenia, 0.61 (95% CI: 0.47 – 0.81; p = 0.001); diarrhea, 1.72 (95% CI: 0.88 – 3.34;p = 0.10); nausea, 2.56 (95% CI: 0.59 – 10.99; p = 0.20); and vomiting, 0.42 (95% CI 0.11 – 1.63; p = 0.21). Conclusions: Ibrutinib increased the risk of all-grade diarrhea and infection whereas the risks of all-grade anemia, high-grade anemia and thrombocytopenia were significantly lower in the study arm, favoring ibrutinib.

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A randomized controlled trial on lactoferrin versus ferrous sulphate for the treatment of mild to moderate iron deficiency anaemia in pregnancy

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20200336 ◽

2020 ◽

Vol 9 (2) ◽

pp. 562

Author(s):

Swati Gawai ◽

Michelle Fonseca ◽

Deepali Kapote

Keyword(s):

Side Effects ◽

Adverse Effects ◽

Controlled Trial ◽

Ferrous Sulphate ◽

Controlled Study ◽

Promising Alternative ◽

Randomized Controlled ◽

Gastrointestinal Side Effects ◽

Group A ◽

Anaemia In Pregnancy

Background: One of the important factors associated with maternal and foetal complications during pregnancy is Anaemia. Various oral preparations of iron are available, and each has different bioavailability, efficacy and adverse effects. Lactoferrin is a naturally existing iron-binding multifunctional glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. Lactoferrin has considerably less gastrointestinal side effects than ferrous sulfate and is very useful as well as promising alternative to ferrous sulphate.Methods: Prospective randomized controlled study. Total 100 females with 24 to 36 weeks of pregnancy with haemoglobin between 8 to 10 grams were included out of which 50 patients were given ferrous sulphate 200 mg BD and 50 patients were given lactoferrin 250 mg BD daily for 8 weeks. Various haematological parameters and the adverse effects of both the drugs were studied at registration, 4 weeks and 8 weeks and compared.Results: Thus, after this study authors can say that the rise in haemoglobin with lactoferrin was 1.58 g/dl while with ferrous sulphate it was 1.67 g/dl at 8 weeks. Adverse effects were much lesser in Group A taking lactoferrin compared to Group B.Conclusions: Thus, lactoferrin has the advantage over ferrous sulphate in having less side effects and increasing the compliance and thus the efficacy of the drug compared to ferrous sulphate.

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Randomized Trial of Erythromycin and Azithromycin for Treatment of Chlamydial Infection in Pregnancy

Infectious Diseases in Obstetrics and Gynecology ◽

10.1155/s1064744995000718 ◽

1995 ◽

Vol 3 (6) ◽

pp. 241-244 ◽

Cited By ~ 9

Author(s):

Marc F. Rosenn ◽

George A. Macones ◽

Neil S. Silverman

Keyword(s):

Side Effects ◽

Screening Tests ◽

Number Of Patients ◽

Significant Difference ◽

Gastrointestinal Side Effects ◽

The Cost ◽

Cure Rates ◽

To Receive ◽

In Pregnancy

Objective:The purpose of this study was to compare erythromycin and azithromycin in the treatment of chlamydial cervicitis during pregnancy with regard to efficacy, side effects, and compliance.Methods:In a prospective manner, 48 pregnant patients with cervical chlamydial infections diagnosed by routine screening tests were randomly assigned to receive either erythromycin, 500 mg q.i.d. for 7 days (N = 24), or azithromycin, 1 g as a one-time dose (N = 24). All sexual partners were given prescriptions for doxycycline, 100 mg b.i.d. for 7 days. The treatment efficacy was assessed by follow-up chlamydia testing 3 weeks after the therapy was completed. The side effects, intolerance to therapy, and overall compliance were evaluated by means of a standardized posttreatment questionnaire.Results:There was no significant difference in cure rates noted between the erythromycin group and the azithromycin group (77% vs. 91%, respectively;P= 0.24). Gastrointestinal side effects were reported more frequently among patients treated with erythromycin compared with patients treated with azithromycin (45% vs. 17%, respectively;P= 0.004). The patients who received erythromycin reported intolerance to therapy secondary to side effects more frequently than patients who received azithromycin (23% vs. 4%, respectively;P= 0.07). Furthermore, the patients in the azithromycin group were more likely to complete their course of therapy as prescribed than the patients in the erythromycin group (100% vs. 61%, respectively;P= 0.002).Conclusions:Azithromycin is efficacious and well tolerated for the treatment of chlamydial cervicitis in pregnancy. Erythromycin, though efficacious, is poorly tolerated, as demonstrated by the number of patients reporting significant side effects during the course of therapy. Since the cost of azithromycin is comparable to that of generic erythromycin, the present study supports the use of azithromycin as an alternative to erythromycin for the treatment of chlamydial cervicitis in pregnancy.

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The Adverse Effect Reporting for the Most Commonly Used Antibiotics

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2020/v32i830467 ◽

2020 ◽

pp. 22-28

Author(s):

Nehad J. Ahmed ◽

Mohammed I. Fouda ◽

Dina I. Fouda ◽

Ahmed I. Foudah

Keyword(s):

Saudi Arabia ◽

Side Effects ◽

Adverse Effects ◽

Health Care Providers ◽

Allergic Reactions ◽

Care Providers ◽

Drug Reactions ◽

Antibiotic Drugs ◽

Pharmacovigilance Center ◽

Gastrointestinal Side Effects

Aim: Antibiotics save lives, but the excess use of antibiotics leads to more side effects. Patients benefit from medications but also complain about their adverse effects. This study aims to explore the reports of the adverse effects for the most commonly used antibiotics in Saudi Arabia. Methodology: The Data regarding the adverse events reports were collected from The National Pharmacovigilance Center in Saudi Arabia. The data include the major allergic reactions and gastrointestinal side effects for the most commonly used antibiotic classes. Results: The total number of allergic and gastrointestinal adverse effects in 2017 and 2018 for the included antibiotic drugs is 583 reports. The majority of the reports were for penicillin antibiotics (39.96) particularly Amoxicillin/Clavunate. Conclusion: The most common adverse effects of antibiotics are allergic and gastrointestinal effects. It is important to report any adverse drug reactions either by health care providers or patients to the Saudi Pharmacovigilance Center.

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Atrial Fibrillation Due to Oral Methylprednisolone in a Patient with Membranoproliferative Glomerulonephritis

Acta Medica (Hradec Kralove Czech Republic) ◽

10.14712/18059694.2017.34 ◽

2008 ◽

Vol 51 (1) ◽

pp. 63-64 ◽

Cited By ~ 3

Author(s):

Ayhan Dogukan ◽

Erdogan Ilkay ◽

Orhan Kürşat Poyrazoğlu ◽

Ali Ihsan Gunal ◽

Metin Ozgen ◽

...

Keyword(s):

Atrial Fibrillation ◽

Side Effects ◽

Adverse Effects ◽

Membranoproliferative Glomerulonephritis ◽

Pulse Methylprednisolone ◽

Cardiac Side Effects

Cardiac adverse effects of intravenous pulse methylprednisolone administration are well known, but there is little information about the cardiac side effects of oral methylprednisolone in the literature. We present a 41 year-old man with membranoproliferative glomerulonephritis in whom developed atrial fibrillation after oral methylprednisolone therapy.

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