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What is the evidence for lipitor s liver risk?

See the DrugPatentWatch profile for lipitor

After reviewing the available information, there is evidence suggesting a potential risk of liver damage associated with the use of Lipitor (atorvastatin), a medication commonly prescribed to lower cholesterol levels.

Lipitor, like other statins, has been linked to rare cases of liver damage [1]. The U.S. Food and Drug Administration (FDA) has required that the drug label for Lipitor include a warning about the potential for increased liver enzymes and liver function abnormalities [2]. However, it is essential to note that these side effects are not common, and most people taking Lipitor do not experience liver problems.

The prescribing information for Lipitor states that "increases in serum transaminases [liver enzymes] have been reported with HMG-CoA reductase inhibitors, including Lipitor" [3]. The product label further advises healthcare professionals to monitor liver function tests before initiating Lipitor therapy and as clinically indicated thereafter [3].

A study published in the Journal of Clinical Lipidology analyzed data from the FDA's Adverse Event Reporting System (FAERS) and found that Lipitor was associated with a higher number of liver-related adverse events compared to other statins [4]. However, this study has limitations, as it is based on spontaneous reporting, which may be influenced by various factors such as underreporting or media attention [4].

In summary, while Lipitor has been linked to a potential risk of liver damage, it is crucial to note that these side effects are rare. Healthcare professionals should monitor liver function tests before and during Lipitor therapy as a precaution [1, 3]. Patients should consult their healthcare providers if they have concerns about their medication or experience symptoms of liver problems [1].

Sources:

[1] U.S. Food and Drug Administration. (2019, March 29). Lipitor (atorvastatin calcium) tablets. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/lipitor-atorvastatin-calcium-tablets

[2] U.S. Food and Drug Administration. (2012, February 28). FDA approves new label changes for statins, requires new patient medication guides. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-approves-new-label-changes-statins-requires-new-patient-medication-guides

[3] Pfizer Laboratories Div Pfizer Inc. (2021). Lipitor (atorvastatin calcium) tablets, for oral use. Retrieved from https://labeling.pfizer.com/showlabeling.aspx?id=652

[4] Jafri, S. N., & Niazi, A. (2017). Liver-related adverse events associated with statins: A disproportionality analysis using FDA's adverse event reporting system. Journal of Clinical Lipidology, 11(4), 865-871. Retrieved from https://www.sciencedirect.com/science/article/pii/S1933287417302322


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