Venous thromboembolism in multiple sclerosis: a report of two cases with pulmonary embolism on dimethyl fumarate and available data from adverse event reporting systems. Time to include disease modifying drugs in the equation?

2020 ◽  
Vol 192 ◽  
pp. 105726 ◽  
Author(s):  
Athanasios Papathanasiou ◽  
Rasha Abdel-Fahim ◽  
Christopher Gilmore ◽  
Nikos Evangelou
Keyword(s):  
Multiple Sclerosis ◽  
Pulmonary Embolism ◽  
Adverse Event ◽  
Venous Thromboembolism ◽  
Dimethyl Fumarate ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Disease Modifying Drugs ◽  
Reporting Systems ◽  
Disease Modifying

Liver injury with drugs used for multiple sclerosis: A contemporary analysis of the FDA Adverse Event Reporting System

2018 ◽  
Vol 25 (12) ◽  
pp. 1633-1640 ◽  
Author(s):  
Ippazio Cosimo Antonazzo ◽  
Elisabetta Poluzzi ◽  
Emanuele Forcesi ◽  
Trond Riise ◽  
Kjetil Bjornevik ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Event ◽  
Liver Injury ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Dimethyl Fumarate ◽  
Population Based ◽  
Adverse Event Reporting ◽  
Drug Induced ◽  
Event Reporting

Background: Drug-induced liver injury (DILI) has been observed in patients with multiple sclerosis (MS), raising concerns on the liver safety of MS drugs. Objective: To describe DILI events with MS drugs by analyzing the FDA Adverse Event Reporting System. Methods: DILI reports were extracted and classified in overall liver injury (OLI), including asymptomatic elevation of liver enzymes, and severe liver injury (SLI). We performed disproportionality analysis by calculating adjusted reporting odds ratios (RORs) with 95% confidence interval (CI) and case-by-case evaluation for concomitant drugs with hepatotoxic potential. Results: Fampridine showed statistically significant ROR for both OLI and SLI, whereas teriflunomide and fingolimod generated solid disproportionality (ROR > 2) only for OLI (ROR, 2.31; 95% CI, 2.12–2.52; and 2.53; 2.40–2.66, respectively). Among monoclonal antibodies, only alemtuzumab generated higher-than-expected ROR for OLI (1.34; 1.09–1.65). We also detected the expected hepatotoxic potential of beta interferon and mitoxantrone. Concomitant reporting of hepatotoxic drugs ranged from 26% (dimethyl fumarate) to 90% (mitoxantrone). Conclusion: These real-world pharmacovigilance findings suggest that DILI might be a common feature of MS drugs and call for (1) formal population-based study to verify the risk of fampridine and (2) awareness by clinicians, who should assess the possible responsibility of MS drugs when they diagnose DILI.

Hospital Adverse Event Reporting Systems

2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Kelly Estrada-Orozco ◽  
Francy Cantor Cruz ◽  
Johana Benavides Cruz ◽  
Miguel Angel Ruiz-Cardozo ◽  
Andrea Marcela Suárez-Chacón ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
Reporting Systems

scholarly journals The efficacy and safety of oral disease-modifying therapies for relapsing-remitting multiple sclerosis: A systematic review

2021 ◽  
Author(s):  
Rahil Sadat Shahtaheri ◽  
Shekoufeh Nikfar ◽  
Elahe Khorasani ◽  
Mansoureh Sabbagh-Baniazad ◽  
Zahra Goudarzi ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Side Effects ◽  
Dimethyl Fumarate ◽  
Oral Disease ◽  
Diabetic Patients ◽  
Mri Findings ◽  
Disease Modifying Drugs ◽  
Relapsing Remitting ◽  
Disease Modifying

Background: Although widely used, first-line injectable medicines for the treatment of multiple sclerosis (MS) remain an issue of efficacy and adherence. Recently, new oral medications for MS have contributed to dramatic improvements in MS treatment. This study aims to evaluate the safety and efficacy of oral disease-modifying drugs (DMDs) used in relapsing-remitting MS (RRMS). Methods: A systematic review was conducted on related databases including PubMed, Scopus, Cochrane, and Web of Science up to April 2020. The screening of the studies and their quality assessment was carried out independently by the two authors. Results: Three studies fulfilled the predefined criteria of inclusion. One of them compared teriflonomide with subcutaneous interferon beta-1a (IFN β-1a), another compared oral fingolimod with intramuscular (IM) IFN β-1b, and the third article compared oral fingolimod with IM IFN β-1a. No eligible study was found for dimethyl fumarate (DMF). The results indicated that while the efficacy of fingolimod was more than IFN β (IM β-1a and β-1b), teriflunomide 7 mg had less efficacy than subcutaneous IFN β-1a. Regarding safety, the results indicated that the proportion of diabetic patients with adverse events (AEs) in the fingolimod group was higher than in the IFN β-1b group and the overall occurrence of AEs was similar between teriflunomide and IFN β-1a groups. Conclusion: There is evidence for the effectiveness of fingolimod in reducing annualized relapse rates (ARRs) and improving magnetic resonance imaging (MRI) findings, but the evidence does not support the effectiveness of teriflunomide and further studies are required to determine its efficacy. Also, fingolimod is associated with more side effects than IFN β-1b, but there is no evidence to suggest any difference in side effects between teriflunomide and IFN β-1a.

Multiple sclerosis as an adverse drug reaction: clues from the FDA Adverse Event Reporting System

2018 ◽  
Vol 17 (9) ◽  
pp. 869-874 ◽  
Author(s):  
Ippazio Cosimo Antonazzo ◽  
Emanuel Raschi ◽  
Emanuele Forcesi ◽  
Trond Riise ◽  
Kjetil Bjornevik ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Drug Reaction ◽  
Adverse Event ◽  
Drug Reaction ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting

Unexpected exacerbations following initiation of disease-modifying drugs in neuromyelitis optica spectrum disorder: Which factor is responsible, anti-aquaporin 4 antibodies, B cells, Th1 cells, Th2 cells, Th17 cells, or others?

2017 ◽  
Vol 23 (9) ◽  
pp. 1300-1302 ◽  
Author(s):  
Jun-ichi Kira
Keyword(s):  
Multiple Sclerosis ◽  
Neuromyelitis Optica ◽  
Th17 Cells ◽  
Dimethyl Fumarate ◽  
Spectrum Disorder ◽  
Aquaporin 4 ◽  
Th2 Cells ◽  
Neuromyelitis Optica Spectrum Disorder ◽  
Disease Modifying Drugs ◽  
Disease Modifying

Some disease-modifying drugs for multiple sclerosis, which mainly act on T cells, are ineffective for neuromyelitis optica spectrum disorder and induce unexpected relapses. These include interferon beta, glatiramer acetate, fingolimod, natalizumab, and alemtuzumab. The cases reported here suggest that dimethyl fumarate, which reduces the number of Th1 and Th17 cells and induces IL-4-producing Th2 cells, is also unsuitable for neuromyelitis optica spectrum disorder, irrespective of anti-aquaporin 4 IgG serostatus. Although oral dimethyl fumarate with manageable adverse effects is easy to initiate in the early course of multiple sclerosis, special attention should be paid for atypical demyelinating cases.

Drug-associated progressive multifocal leukoencephalopathy in multiple sclerosis patients

2018 ◽  
Vol 25 (8) ◽  
pp. 1141-1149 ◽  
Author(s):  
Yasuo Oshima ◽  
Tetsuya Tanimoto ◽  
Koichiro Yuji ◽  
Arinobu Tojo
Keyword(s):  
United States ◽  
Multiple Sclerosis ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Dimethyl Fumarate ◽  
The United States ◽  
Disease Modifying Drugs ◽  
Disease Modifying ◽  
Multiple Sclerosis Patients ◽  
Time To Onset

Objective: To investigate characteristics of multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients associated with drugs other than natalizumab since our experience in other disease-modifying drugs (DMD) is still limited. Methods: This is a descriptive observational study within the FAERS database, registered between July 2015 and June 2017. Results: The primary cohort for the analysis consisted of 100,921 MS patients (mean (standard deviation (sd)) age, 48.9 (12.8) years, 20.9% male). Among them 786 (0.78%) developed PML. The adjusted odds ratio of PML for each drug was as follows; natalizumab 115.72 (95% CI; 83.83, 159.74), fingolimod 4.98 (3.64, 6.81) followed by dimethyl fumarate 1.77 (1.2, 2.62) and rituximab 3.22 (1.07, 9.72). The median time from the start of suspected drugs to the onset of PML for natalizumab and other agents were 1463 and 178 days, respectively. The proportion of PML appeared higher in Japan (2.4%) compared to that in the United States (0.24%). Conclusion: The reporting proportion of PML was relatively higher in natalizumab followed by fingolimod, dimethyl fumarate and rituximab. Other characteristics of PML associated with DMDs, including the time to onset and differences in reporting among countries, are described.

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