Pharmaceuticals

Ocaliva Lawsuits

Ocaliva LawsuitOcaliva (obeticolic acid) is a medication prescribed for the treatment of Primary Biliary Cholangitis (PBC), a rare liver disease causing inflammation and destruction of the bile ducts in the liver. Although Ocaliva has been prescribed to treat PBC, the U.S. Food and Drug Administration (FDA) has issued warnings concerning PBC worsening in patients on a PBC regimen. The FDA approved a black box warning in February 2018 for Ocaliva due to reports of serious injury and death in users.
 

Ocaliva Lawyers are Ready to Help

Contact our Ocaliva Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Ocaliva cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Ocaliva Lawyers at our law firm, please call 1-800-988-8005 or submit an email inquiry above.
 

What is Ocaliva?

Ocaliva was a drug approved by the FDA in May 2016 to lessen the symptoms associated with PBC, including fatigue, itchy skin, abdominal pain, and dry eyes and mouth. PBC gradually destroys the bile ducts in the liver, building up dangerous substances in bile. These can cause damage to the liver. Ocaliva slows the production of bile in the liver and assists in directing bile flow out of the liver. Ocaliva may also help to slow the progression of PBC.
 

What is Happening with Ocaliva?

Ocaliva has been reported to cause serious liver injuries in patients who take the medication at certain dosages to treat the symptoms of PBC. The FDA has issued several alerts related to Ocaliva to warn patients of the risk of serious liver injury or death.

The FDA first alerted consumers to the complications associated with Ocaliva in a Drug Safety Communication in 2017. The warning stated that patients with impaired liver function may be taking excessive doses of Ocaliva, thereby increasing the possibility of severe liver injuries.  The FDA also warned that patients with a mild form of PBC may experience liver injury when taking the correct dose.

In February 2018, the FDA added a black box warning on the label and medication guide to correct the prescribing and dosage information for Ocaliva. The warning updates the recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease. Finally, in October 2020, the FDA announced a liver safety evaluation to assess the potential for liver disorder with use of Ocaliva.

https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-highlight-correct-dosing-ocaliva-obeticholic-acid-patients-rare-chronic-liver
 

Ocaliva Side Effects and Complications

Side effects of Ocaliva include:

  • Skin itching;
  • Nausea;
  • Vomiting;
  • Abdominal pain;
  • Yellowing of eyes and skin;
  • Muscle and joint pain;
  • Swelling of legs, feet and abdomen; and
  • Mood changes.

Serious complications of Ocaliva include:

  • Liver injury;
  • Liver failure;
  • Drug-induced hepatitis;
  • Hepatic failure;
  • Hepatic necrosis;
  • Hepatorenal syndrome; and
  • Death.

 

Ocaliva Lawyers are Ready to Help

Contact our Ocaliva Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Ocaliva cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Ocaliva Lawyers at our law firm, please call 1-800-988-8005 or submit an email inquiry above.

For more information about the law firm's practice areas please contact Levy Konigsberg LLP at 1-212-605-6200 or 1-800-988-8005, 24 hours a day, 7 days a week.

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