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Study: Plavix and Increased Risks for Antiplatelet Hepatitis, Liver Damage

Study: Plavix and Increased Risks for Antiplatelet Hepatitis, Liver Damage

Our firm is investigating potential lawsuits on behalf of users of the drug Plavix (clopidogrel bisulfate). Plavix was approved in the United States in 1997 and is an antiplatelet agent prescribed to reduce the risk of atherosclerotic events such as blood clot, stroke, and heart attack in patients with a history of these conditions.

Plavix lawsuits include allegations of serious side effects, including gastrointestinal bleeding, cerebral bleeding, thrombotic thrombocytopenic purpura (TTP), and other problems.

Case Study: Plavix and Antiplatelet Hepatitis

According to a July 2016 report issued by Monthly Prescribing Reference (, a recent case, published in Case Reports in Hepatology, reports on a patient who was diagnosed with severe hepatitis that was likely associated with Plavix.

A 24-year-old man who had taken Plavix and aspirin for 4.5 months for coronary artery disease, as well as a remote coronary artery stent, suffered from jaundice and fatigue. Jaundice is the yellowing of skin and sclera (the whites of the eyes) due to abnormally high blood levels of the bile pigment, bilirubin. The patient indicated that he had not recently consumed alcohol or herbal supplements and stated that he was not suffering from abdominal pain, fever, rash, or arthralgias (joint pain). His baseline liver function tests returned as normal at the time of his original Plavix treatment. He took Plavix for 4.5 months prior to presenting with these symptoms; 12 years earlier, he had taken Plavix for two months with no apparent issues and stopped taking the drug on his own.

Aside from jaundice, no other physical signs of chronic liver disease were present. All relevant test results returned with normal ranges. He also tested negative for a variety of diseases involving the liver, including hepatitis A, B, C, E; cytomegalovirus; Epstein-Barr virus; anti-nuclear antibody; anti-smooth muscle antibody; anti-liver kidney microsomal antibody; anti-mitochondrial antibody; and ceruloplasmin. Imaging including ultrasound, computed tomography (CT), endoscopic retrograde cholangiopancreatography, and all returned with negative results. The patient's bile ducts were not dilated, and there were no gallstones present.

Plavix & Increased Risks for Antiplatelet Hepatitis

Despite these test results, the patient's liver biopsy confirmed severe acute hepatitis with mixed inflammatory portal tract infiltrates. He was diagnosed with clopidogrel-induced severe hepatitis. After being taken off Plavix, and even following vitamin K treatment, the patient's liver-related test results worsened. His liver biochemistries only normalized after prednisone and ursodiol were introduced in his treatment.

The patient's drug-induced hepatitis was particularly severe and his tests and diagnoses revealed marked elevation in transaminases, jaundice, and coagulopathy. Although rare, this side effect was previously described in other case reports in which the degree of damage ranged from reversible liver injury due to acute hepatic (liver) failure and death.

Some cases were confirmed when patients were re-treated with Plavix. Liver injury symptoms began from three to 180 days following treatment. According to the researchers, this case suggests that the mechanism by which Plavix causes hepatocellular (liver) injury may have a toxic-metabolic origin. Studies suggest the active metabolite of Plavix may be responsible for hepatotoxicity (chemical- or drug-driven liver damage). What's more, in this case, two different scales-the Naranjo scale and the Roussel Uclaf Causality Assessment Method-indicated Plavix as the probable cause of the patient's hepatitis, according to

The study authors concluded that clopidogrel-induced hepatitis should be suspected in patients who present with abnormal liver enzymes within months of initiating therapy with Plavix and that "prompt recognition and discontinuation of the offending agent are necessary, as progressive liver injury and even death can occur."


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