AI Article Synopsis
- Phthalates are additives in drugs that may harm reproduction, leading the EMA to set exposure limits.
- The study identified UK medicines containing these phthalates, checking their levels against EMA guidelines.
- Out of 54 medicines found, only 6 exceeded the recommended levels, suggesting limited impact from the EMA guidelines but highlighting the need for risk assessment on those particular medicines.
Article Abstract
Background: Phthalates are excipients in drug formulations. However, concerns have been raised about the effects of particular phthalates on reproduction and development. As a result the EMA has introduced guidelines for permitted daily exposure (PDE) limits for certain phthalates. Therefore, the objective of this study was to identify UK licensed medicines that contain the relevant phthalates and determine if they fall within the recommended PDE.
Methods: The eMC was used to identify which UK licensed medicines contain the phthalates in question. Companies were then contacted for information on the phthalate levels in their products, which was compared with the PDE recommended by the EMA.
Results: The eMC search revealed that 54 medicines contained at least one of the phthalates in question. However, only six medicines, namely Asacol 800 mg MR (Warner Chilcott UK), Epilim 200 Gastro-resistant tablets (Sanofi), Prednisolone 2.5 mg and 5 mg Gastro-resistant tablets (Actavis UK), Vivotif (Crucell Italy S.r.l), and Zentiva 200 mg Gastro-resistant tablets (Winthrop Pharmaceuticals UK), were identified as containing levels that exceeded the recommended PDE.
Conclusions: These findings indicate that very few UK licensed medicines will be affected by the proposed EMA guidelines. For those medicines identified as exceeding recommendations, these findings highlight the need to instigate a risk-benefit review.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4465162 | PMC |
| http://dx.doi.org/10.1186/s40360-015-0018-9 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Removing Ineffective Drugs From the Market: Implications for Oral Phenylephrine and Beyond.
JAMA
January 2025
Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California.
Growth hormone-releasing hormone signaling and manifestations within the cardiovascular system.
Rev Endocr Metab Disord
January 2025
Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Biomedical Research Building, 1501 N.W. 10th Avenue, Room 908, Miami, FL, 33136, USA.
Growth hormone (GH)-releasing hormone (GHRH), a hypothalamic peptide initially characterized for its role in GH regulation, has gained increasing attention due to its GH-independent action on peripheral physiology, including that of the cardiovascular system. While its effects on the peripheral vasculature are still under investigation, GHRH and synthetic agonists have exhibited remarkable receptor-mediated cardioprotective properties in preclinical models. GHRH and its analogs enhance myocardial function by improving contractility, reducing oxidative stress, inflammation, and offsetting pathological remodeling.
View Article and Find Full Text PDFEfficacy and safety of risankizumab for the treatment of patients with plaque type psoriasis.
Ital J Dermatol Venerol
January 2025
Department of Dermatology, College of Medicine, National Taiwan University Hospital, National Taiwan University, Taipei, Taiwan (ROC) -
Risankizumab (Skyrizi, Abbvie, North Chicago, IL, USA) is a humanized immunoglobulin (Ig) G1 monoclonal antibody targeting the p19 subunit of IL-23, thereby inhibiting IL-23-dependent releasing of proinflammatory cytokines in plaque psoriasis. Risankizumab is licensed is most countries for the treatment of patients with moderate-to-severe plaque psoriasis, and in Japan for generalized pustular psoriasis, erythrodermic psoriasis and palmoplantar pustulosis. Risankizumab showed higher efficacy and favorable safety profiles in patients with moderate-to-severe plaque psoriasis, compared with adalimumab, secukinumab and ustekinumab in several randomized controlled phase 3 pivotal studies and among real-life data in large retrospective studies.
View Article and Find Full Text PDFReal-world Plasma Exposure of Nirmatrelvir/Ritonavir in Chinese Hospitalized Patients With COVID-19: A Multicenter Retrospective Study.
Ther Drug Monit
January 2025
School of Pharmaceutical Sciences, Hangzhou First People's Hospital, Zhejiang Chinese Medical University, Hangzhou, China.
Background: Nirmatrelvir/ritonavir is licensed for the treatment of mild-to-moderate coronavirus disease (COVID-19) in patients at an increased risk of progression to severe disease. However, data on the real-world plasma exposure to nirmatrelvir/ritonavir remain limited, particularly in Chinese patients. This study aimed to assess the nirmatrelvir/ritonavir trough concentration (Ctrough) and identify its critical factors in hospitalized Chinese patients treated with nirmatrelvir/ritonavir 300 mg/100 mg twice daily over a 5-day course.
View Article and Find Full Text PDFDevelopment of digital therapeutics in Hwa-byung treatment: exploring innovation potential in Korean medicine through practitioner survey.
Front Med (Lausanne)
January 2025
Department of Oriental Neuropsychiatry, College of Korean Medicine, Dong-Eui University, Busan, Republic of Korea.
Introduction: Hwa-byung (HB) is a culture-bound anger syndrome prevalent in Korea. While clinical practice guidelines emphasize mind-body modalities (MBMs) and psychotherapies for HB treatment, their implementation in Korean medicine (KM) remains unexplored. Digital therapeutics (DTx) offers potential solutions for treatment delivery barriers.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!