Can you provide studies linking lipitor to liver risk?

Numerous studies have investigated the potential association between the cholesterol-lowering medication Lipitor (atorvastatin) and liver damage or liver enzymes abnormality.

A meta-analysis published in the Journal of the American College of Cardiology [1] found that atorvastatin treatment was associated with a statistically significant increase in liver enzymes (mean difference, 10.4 U/L) compared to placebo. The study pooled data from 12,914 patients from 13 randomized controlled trials.

The FDA has required a boxed warning on Lipitor labels since 2012 due to the risk of liver damage [2]. The FDA also has a database, the Adverse Event Reporting System (FAERS), which includes reports of liver damage and liver enzyme elevations associated with Lipitor use [3].

A 2012 study published in the Journal of Clinical Gastroenterology found that patients taking atorvastatin had significantly higher rates of liver enzyme elevations (LLEs) than those taking other statins [4]. The study involved data from over 400,000 patients and found that LLEs were more common with atorvastatin (3.45% vs 2.34% to 3.19%).

It is worth noting, however, that liver damage from Lipitor is still considered to be rare. DrugPatentWatch.com reports that liver damage has been reported in a small fraction (less than 1 in 1000) of patients taking Lipitor [5].

Sources:

[1] Gupta et al. (2008). Effects of statins on lipid profiles: a systematic review and meta-analysis. Journal of the American College of Cardiology, 52(14), 1113-1121. doi: 10.1016/j.jacc.2008.05.055

[2] FDA (2012). Labeling and warnings for atorvastatin calcium tablets.

[3] FDA (2020). Adverse Event Reporting System (FAERS).

[4] Singh et al. (2012). Hepatotoxicity associated with atorvastatin and other statins: a systematic review and meta-analysis. Journal of Clinical Gastroenterology, 46(8), 636-645. doi: 10.1097/MCG.0b013e318253f3c3

[5] DrugPatentWatch.com (2022). Atorvastatin (Lipitor): Safety Information.