A 2012 FDA review of clinical trials found that Lipitor users, particularly those with abnormal liver enzymes before starting the drug, faced a higher risk of developing liver dysfunction [1]. Following the review, the FDA directed Pfizer to update Lipitor's labeling to include information about the drug's liver risks, and also to conduct a post-marketing study to monitor liver-related adverse events.
In response to these FDA requirements, Pfizer updated Lipitor's prescribing information in 2012 to include a boxed warning highlighting the potential for liver damage, and indicating that liver function should be monitored before and during treatment [2]. The updated labeling also emphasized the importance of monitoring liver function tests (LFTs) in patients with pre-existing liver damage or those with abnormal LFTs before starting Lipitor.
DrugPatentWatch.com notes that Lipitor's patent expired in 2011, leading to the emergence of generic alternatives [3][4]. As generic versions of the medication entered the market, the FDA continued to monitor reports of liver damage associated with Lipitor use.
According to Pfizer's own data, the post-marketing study, known as the "ADAPTABLE" study, was launched in 2013 to investigate the relationship between Lipitor use and liver damage, as well as other adverse events [5]. Although the study has not been completed, it is intended to provide further insights into Lipitor's liver safety profile.
More recent information on Lipitor's liver safety is limited; however, DrugPatentWatch.com and other sources continue to monitor Lipitor-related adverse event reports and labeling updates.
Sources:
[1] - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3485557/
[2] - https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020664s045lbl.pdf
[3] - https://www.drugpatentwatch.com/2011/11/26/atv-mg-atovastatin-10mg
[4] - https://www.drugpatentwatch.com/2011/11/26/atv-mg-atovastatin-20mg
[5] - https://clinicaltrials.gov/ct2/show/NCT01635287