- Design
- Case-non-case disproportionality analysis of spontaneous reports in VigiBase (1968 to October 2023)
- Population
- 29,897 reported lithium reactions compared with reports for second-generation antipsychotics, ages above 2 years
- Primary outcome
- Proportional reporting of adverse drug reaction categories by age group
- Effect
- In children, higher proportions of renal, endocrine, gastrointestinal, skin and cardiac reports with lithium (no single pooled estimate in the abstract)
This VigiBase analysis compared individual case safety reports for lithium (29,897 reported reactions) with those for second-generation antipsychotics in people over 2 years old, using proportional reporting ratios across age groups.
In children, lithium reports contained a higher proportion of renal, endocrine, gastrointestinal, skin and cardiac reactions than reports for antipsychotics, with thyroid reactions proportionally more common in children than in other age groups. Severe outcomes such as renal failure were proportionally more common in older adults. Antipsychotic reports showed metabolic and cardiovascular patterns in adults and weight-related reactions in children.
Proportional reporting describes the mix of reported reactions, not their incidence, and spontaneous reports are affected by reporting habits. Nothing here shows that lithium is riskier than an antipsychotic overall. It supports routine monitoring of kidney and thyroid function and vigilance for gastrointestinal effects in young patients.
- Check renal and thyroid function before lithium in children and at regular intervals afterwards.
- Monitor serum lithium levels and review interacting drugs, including anti-inflammatories.
- Ask about thirst, polyuria, tremor and gut symptoms at each visit.
- Report suspected reactions to your pharmacovigilance centre.
Why it matters
It points to which organ systems to watch in young patients on lithium.
Don't overread it
Spontaneous report data cannot give incidence or show that one drug is safer than another.
The statistics, in plain English
A proportional reporting ratio compares how large a share of one drug's reports a reaction makes up against another drug's reports. It cannot give the risk of a reaction, because the number of people taking each drug is unknown.
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