Abstract
BackgroundCancer had never been considered as a relevant problem in patients treated with lithium until 2015, when a document published by the European Medicine Agency concluded that long-term use of lithium might induce renal tumors. A few months later, we observed the case of a woman treated with lithium for 18 years who was diagnosed with both thyroid and renal tumors.MethodsThis study aimed to investigate the correlation between lithium treatment and thyroid or renal tumors. We analyzed clinical records in our lithium clinic database, causes of death of patients who had been visited at least once at the lithium clinic, reports of lithium adverse reactions in the European and WHO pharmacovigilance databases, and published cases of thyroid and renal tumors in long-term lithium-treated patients.ResultsOf the 1871 lithium patients who had been visited at least once between 1980 and 2013, eight had been diagnosed with thyroid papillary carcinoma and two with clear-cell renal-cell carcinoma. No cases of thyroid cancer and only one case of renal tumor were the cause of death according to the 375 available death certificates. VigiAccess database contained a total of 29 and 14 cases of renal and thyroid tumors, respectively. EudraVigilance database contained 21 cases of renal and 8 of thyroid neoplasms. Literature search yielded 6 published cases of thyroid papillary carcinoma and 25 cases of various renal tumors. However, two population-based studies did not find any increased risks of cancer in patients exposed to lithium, whereas two nationwide studies did not find any excess of renal tumors.ConclusionSo far it has not been possible epidemiologically to confirm an increased risk of thyroid or renal cancers associated with lithium. Such a conclusion is supported by the findings of low rates and mortalities of thyroid or renal cancers from the present lithium clinic data.
Highlights
Cancer had never been considered as a relevant problem in patients treated with lithium until 2015, when a document published by the European Medicine Agency concluded that long-term use of lithium might induce renal tumors
The interest in the potential association between lithium therapy and tumors has recently been revived by a document issued by the European Medicine Agency (EMA) (2015), which adopted the following recommendation: “in light of the data available, the PRAC (Pharmacovigilance Risk Assessment Committee) has agreed that the evidence is sufficient to conclude that long-term use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas
The present study was prompted by a series of circumstances: (a) our group serves as the Sardinian Pharmacovigilance Center; (b) our group has been running a lithium clinic since the 1970s and is in possession of detailed clinical data regarding patients on maintenance treatment with lithium; (c) in 2015, a few months after the publication of the aforementioned EMA document, we observed the case of a woman treated with lithium for 18 years who was diagnosed with both thyroid and renal tumors
Summary
Cancer had never been considered as a relevant problem in patients treated with lithium until 2015, when a document published by the European Medicine Agency concluded that long-term use of lithium might induce renal tumors. The interest in the potential association between lithium therapy and tumors has recently been revived by a document issued by the European Medicine Agency (EMA) (2015), which adopted the following recommendation: “in light of the data available, the PRAC (Pharmacovigilance Risk Assessment Committee) has agreed that the evidence is sufficient to conclude that long-term use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas. The present study was prompted by a series of circumstances: (a) our group serves as the Sardinian Pharmacovigilance Center; (b) our group has been running a lithium clinic since the 1970s and is in possession of detailed clinical data regarding patients on maintenance treatment with lithium; (c) in 2015, a few months after the publication of the aforementioned EMA document, we observed the case of a woman treated with lithium for 18 years who was diagnosed with both thyroid and renal tumors
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