Ischemic Colitis with Type I Interferons Used in the Treatment of Hepatitis C and Multiple Sclerosis: An Evaluation from the Food and Drug Administration Adverse Event Reporting System and Review of the Literature

2013 ◽  
Vol 47 (4) ◽  
pp. 537-542 ◽  
Author(s):  
Allison Salk ◽  
Derrick J Stobaugh ◽  
Parakkal Deepak ◽  
Eli D Ehrenpreis
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Event ◽  
Hepatitis C ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Type I Interferons ◽  
Type I ◽  
Review Of The Literature ◽  
Event Reporting

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

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.

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