Current Drug Safety

Journal Information
ISSN / EISSN: 15748863 / 22123911
Total articles ≅ 915

Latest articles in this journal

Kala Paneerselvam, Kiran Belur, Jamuna Rani Raveendran
Published: 1 November 2023
Current Drug Safety, Volume 18, pp 534-539; https://doi.org/10.2174/1574886318666221213102924

Abstract:
Background: Asthma is a chronic inflammatory disease of the small airways. Chronic inflammation often causes hyper responsiveness of airways with wheezing, breathing difficulty, cough and chest tightness. Objective: The present study aimed to evaluate the drug usage pattern of anti-asthma drugs among asthma patients. Methods: The present study was a prospective, observational cross-sectional study carried out among 422 outpatients being treated at the respiratory medicine department, SRM Medical College Hospital and Research Centre. Data regarding the prescribing indicators and patient indicators were collected from the patients’ prescription slips and entered in the preformed proforma. Prescribing indicators were taken into consideration in evaluating the rationality of prescriptions. Results: In the present study, 49% of patients were between the age group of 20-40 years. Genderwise distribution showed 58.05% of males and 41.95% of females. A family history of asthma was seen in 68% of the study population. The present study reported smoking among 51% and tobacco chewing in 21% of the study population. Low economic strata were observed in 77.9% of the study population. According to asthma grading, 65.8% were in the mild intermittent, and 25% were in the mild persistent group. Patients were on β2 agonists (35.4%) and corticosteroids (32%). The most commonly used fixed drug combination was a short-acting β2 agonist with corticosteroid (40.5%). A total of 68% of drugs were used by the inhalational route and 29% by the oral route. Conclusion: The findings showed that, the most frequently prescribed drug was a short-acting β2 agonist with corticosteroid in a fixed-dose combination via inhalational route.
Dhanya Jose, Nitin Dhupdale, Jagadish A. Cacodcar, Umesh Kamat
Published: 1 November 2023
Current Drug Safety, Volume 18, pp 516-527; https://doi.org/10.2174/1574886317666220803104438

Abstract:
Background: COVISHIELD, ChAdOx1 nCoV- 19 Corona Virus Vaccine was granted emergency use authorization (EUA) as the first vaccine in India in January 2021. Knowing what to anticipate after vaccination will reduce vaccine hesitancy in the public. This study aimed to identify and measure the adverse events following COVID-19 vaccination. Materials and Methods: A cross-sectional observational study was conducted at Goa Medical College, starting on February 21 till May 23, 2021. A total of 418 people were enrolled. We collected the data using the Microsoft Form and analyzed using Microsoft Excel and R-program. Results: Of the 418 vaccine recipients, the incidence rate of AEFI (Adverse Events Following Immunization) was 54.31%. Fever, fatigue, and headache were the most commonly reported systemic AEFIs. Among these, 54.7% of AEFI were mild, 42.38% were of the moderate category, and only 2.96% were of grade 3 severity. None of the AEFIs were severe enough for hospitalization. Most of them developed symptoms within 24 hours of the first dose. Complete recovery from AEFIs took a median time of 24 hours. Conclusion: Most of our study findings were consistent with the phase 1, 2/3 trials findings of Oxford-AstraZeneca's ChAdOx1 vaccine. The AEFI symptoms were considered immune reactions to the vaccine. The AEFIs were more common among younger individuals and females. The chance of missing a serious adverse event like a thromboembolic phenomenon cannot be ruled out. We observed low AEFI rates with COVISHIELD in the Indian population compared to Oxford- AstraZeneca's ChAdOx1 vaccine in the UK-based population, which can be explained by preexisting immunity against adenovirus in the Indian population. However, based on the study findings, we may interpret that the COVISHIELD, Serum Institute of India, carries a good safety profile overall.
Rozita Khodashahi, Ali Ghasemi, Mohsen Aliakbarian, Ebrahim Khaleghi, Baran Razmkhah, Mehrsa Vahdatinia, Mahdi Salimi Far, Omolbanin Bakhti
Published: 1 November 2023
Current Drug Safety, Volume 18, pp 540-546; https://doi.org/10.2174/1574886317666220801122822

Abstract:
Background: Considering the dearth of research on the complications of Sinopharm coronavirus disease 2019 (COVID-19) vaccine in immunocompromised individuals and the lack of available data on COVID-19 vaccination from Iran. Objective: This study aimed to investigate the efficacy of vaccine of Sinopharm COVID-19 vaccine and its complications in bone marrow transplant (BMT) recipients. Methods: This was a retrospective cross-sectional study conducted on 250 patients with BMT who were referred to Montaserieh Hospital, Mashhad, Iran. Among them, 53 cases who received at least two doses of Sinopharm COVID-19 vaccine from March to January 2021 were entered in this study. The data were extracted from a student dissertation (Code:4000370). Results: Sinopharm vaccine side effects were reported only in 7.7% of the patients, and shingles was the only serious side effect of the Sinopharm vaccine, which was observed only in one case. The results also revealed that Sinopharm COVID-19 vaccine side effects were not related to age or gender. Infection with the Delta variant of COVID-19 was reported in 7.5% (n=4) and no mortality was reported among them. Vaccine failure was reported in 39.6% of the cases; however, no mortality was reported among patients infected with the Omicron variant of COVID-19. Conclusion: In summary, it seems that Sinopharm COVID-19 vaccine adverse effects were not serious among stem cell transplant recipients. However, it may lead to some severe complications in the population. Vaccine failure against the Delta and Omicron variants of COVID-19 has been reported among more than one-third of BMT patients; however, no mortality was observed among BMT patients infected with the new variants of COVID-19.
, Parisa Ghasemiyeh, Afsaneh Vazin
Published: 1 November 2023
Current Drug Safety, Volume 18, pp 425-439; https://doi.org/10.2174/1574886317666220801124718

Abstract:
Vancomycin is considered the drug of choice against many Gram-positive bacterial infections. Therapeutic drug monitoring (TDM) is essential to achieve an optimum clinical response and avoid vancomycin-induced adverse reactions including nephrotoxicity. Although different studies are available on vancomycin TDM, still there are controversies regarding the selection among different pharmacokinetic parameters including trough concentration, the area under the curve to minimum inhibitory concentration ratio (AUC24h/MIC), AUC of intervals, elimination constant, and vancomycin clearance. In this review, different pharmacokinetic parameters for vancomycin TDM have been discussed along with corresponding advantages and disadvantages. Also, vancomycin pharmacokinetic assessments are discussed in patients with altered pharmacokinetic parameters including those with renal and/or hepatic failure, critically ill patients, patients with burn injuries, intravenous drug users, obese and morbidly obese patients, those with cancer, patients undergoing organ transplantation, and vancomycin administration during pregnancy and lactation. An individualized dosing regimen is required to guarantee the optimum therapeutic responses and minimize adverse reactions including acute kidney injury in these special groups of patients. According to the pharmacoeconomic data on vancomycin TDM, pharmacokinetic assessments would be cost-effective in patients with altered pharmacokinetics and are associated with shorter hospitalization period, faster clinical stability status, and shorter courses of inpatient vancomycin administration.
, Mouna Ben Sassi, Rim Charfi, Hanene El Jebar, Riadh Daghfous, Emna Gaies, Sameh Trabelsi
Published: 1 August 2023
Current Drug Safety, Volume 18, pp 340-344; https://doi.org/10.2174/1574886317666220525112713

Abstract:
Tuberculosis is a challenge in organ transplantation due to the interaction between Anti- Tuberculosis Treatment (ATT) and immunosuppressive drugs, such as Tacrolimus (TAC). This study aimed to assess this interaction and discuss the guidelines used in this specific case. Methods: A retrospective, observational, single-center analysis was performed at the Department of Clinical Pharmacology (National Centre of Pharmacovigilance, Tunisia). We analyzed the database of patients who received TAC from 2009 until 2018. We included samples provided from renal transplant patients infected by Mycobacterium tuberculosis after transplantation. Trough blood levels (C0) were determined using an immunoassay analyzer. The Therapeutic Range (TR) of TAC was considered between 5 and 10 ng/mL. Pharmacokinetic parameters were compared between the period of co-administration of TAC/ATT (period A) and the period during which patients received only TAC (period B). Results: Seven renal transplant patients treated by TAC were included. 41 samples were analyzed (16; period A, 25; period B). Only 6 % of C0 values were found within TR during period A, while this rate was 44% during period B. During period A, 88% of TAC C0 was under the lower limit of TR, indicating a high risk of transplant rejection. The mean C0 and C0/D were significantly lower during period A (3.11±1.53 ng/mL vs 7.11 ± 3.37 ng/mL; p = 0.001 and 33.06 ± 24.89 vs 83.14 ± 44.46; p = 0.0006, respectively), without difference in doses between periods. Conclusion: Considering the results of this study, clinicians are suggested to monitor TAC closely in this particular circumstance.
, Maatallah Kaouther, Kaffel Dhia, Ferjani Hanene, Triki Wafa, Ben Nessib Dorra, Hamdi Wafa
Published: 1 August 2023
Current Drug Safety, Volume 18, pp 383-385; https://doi.org/10.2174/1574886317666220428132311

Abstract:
Background: Caplan's syndrome, also known as rheumatoid pneumoconiosis (RP), is a rare disease associating pneumoconiosis with rheumatoid arthritis (RA). This is one of the rare cases evaluating the effect of Rituximab, which was used initially for the treatment of RA, on pneumoconiosis. Case presentation: In this case report, we described a 21-year long-standing history of pneumoconiosis and its association with RA. A 67-year-old man diagnosed with pneumoconiosis presented with morning stiffness and symmetrical polyarthritis. Laboratory investigations showed high titers of rheumatoid factor (RF) and anti-citrullinated protein antibodies. The diagnosis of RA was established and the patient was put on leflunomide. Then, he was treated with Rituximab, as he did not respond to leflunomide. The patient showed marked improvement as pain and swelling decreased. More importantly, Caplan’s nodules stabilized on chest-computed tomography. Conclusion: The use of rituximab in pneumoconiosis does not alter the evolution of the pulmonary nodules. More trials are needed to establish a treatment consensus for RP.
Chandrashekar Kodangala Subraya, Kemisha Sanghvi, Vasudev Pai, Aswatha Ram Holavanna Halli Nanjundaiah, Vijayanarayana Kunhikatta
Published: 1 May 2023
Current Drug Safety, Volume 18, pp 138-142; https://doi.org/10.2174/1574886317666220428125943

Abstract:
There is a growing awareness of a disease at many levels, its treatment, and treatment outcomes including side effects. Alternative therapy techniques, herbal medicines and formulations are extensively acknowledged and practiced in India and around the world. Herbal medicine is usually considered being safe regardless of the absence of scientific evidence to support its claims. Several issues concerning the methods in which herbal medications are labelled, evaluated, sourced, and used are connected to herbal medicine. Herbal therapeutics in the management and treatment of diabetes, rheumatism, hepatic disorders and other mild to chronic diseases and disorders are widely accepted. However, the adversities are difficult to recognize. The idea that the nature is safe and may be taken without the prescription of a physician has resulted in widespread self-medication across the world, sometimes with disappointing results, side effects, or unpleasant after-effects. The existing pharmacovigilance paradigm and its accompanying tools were created in connection with synthetic medicines. Nevertheless, adopting these approaches to keep records of herbal medications’ safety poses a distinct challenge. This might be due to the variations in the usage of non-traditional medicines, which can offer unique toxicological issues whether taken alone or in conjunction with other medications. The goal of pharmacovigilance is to identify, analyse, explain, and minimize the adverse reactions and other drug-related complications associated with herbal, traditional, and complementary medications. Systematic pharmacovigilance is required to collect accurate data on the safety of herbal medications to create adequate guidelines for effective and safe usage.
Tauqeer Hussain Mallhi, Yusra Habib Khan, , Muhammad Salman
Published: 1 May 2023
Current Drug Safety, Volume 18, pp 122-124; https://doi.org/10.2174/1574886317666220428133813

Abstract:
The Coronavirus disease (COVID-19) outbreak is marked by infodemic amid conspiracy theories, false claims, rumors, and misleading narratives, which have had a significant impact on the global campaign against COVID-19. The drug repurposing provides a hope to curb the growing encumbrance of the disease but at the same time, it poses various challenges such as selfmedication using repurposed drugs and its associated harms. During the continuing pandemic, this perspective piece explores the potential hazards of self-medication and its attributing factors along with possible countermeasures.
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