Does methylphenidate cause liver damage? An analysis of spontaneous reports to the German Federal Institute for Drugs and Medical Devices

Introduction:

Psychostimulants, such as methylphenidate (MPH) and amphetamine, are commonly prescribed for attention-deficit/hyperactivity disorder and have been a first-line medication for this disorder for over 60 years. However, there are concerns that treatment with MPH may cause hepatic adverse drug reactions (ADRs).

Methods:

Using the database of the German Federal Institute for Drugs and Medical Devices we analyzed spontaneous reports on suspected hepatic ADRs occurring under treatment with MPH from 2006 to 2016. Using the Standardized MedDRA Queries search strategy, we searched the database for “MPH” and its potential ADRs “Hepatic Disorder.” The ad-hoc reports were checked for completeness and suspected cases were investigated for a plausible causal relationship based on the clinical Uppsala Monitoring Centre criteria.

Results:

60 suspected cases of liver damages associated with MPH were recorded in the database. In 15 thereof, an assessment was not possible because of insufficient documentation; in 25 cases a link between the intake of MPH and the occurrence of liver injury was considered “unlikely.” A “possible” causality was assessed in 11 cases, a “probable/likely” causality in 9 cases: 1 patient with fulminant hepatitis, 1 with increased size of benign liver tumor, and 18 cases of (reversible) hepatic enzyme elevation.

Conclusion:

According to our evaluation, MPH is well-tolerated with regard to liver and gall bladder diseases. For patients with hepatic impairment or other risk factors, regular monitoring of liver values is recommended.