PARKER WAICHMAN LLP – OCALIVA CHRONIC LIVER DISEASE LAWSUIT LAWYERS
Parker Waichman LLP is currently investigating potential Ocaliva chronic liver disease lawsuits for individuals with primary biliary cholangitis (PBC) who have suffered serious liver injuries after taking the drug. If you have taken Ocaliva and subsequently sustained serious liver injuries, you may be entitled to compensation.
Ocaliva and the Treatment of Primary Biliary Cholangitis (PBC) – What You Should Know
Ocaliva (obeticholic acid – OCA) is a drug used in the treatment of primary biliary cholangitis (PBC), which is a rare chronic liver disease. Ocaliva is manufactured by Intercept Pharmaceuticals, Inc., and there is currently no generic equivalent. Patients suffering from PBC rely on ‘Ocaliva’ to alleviate the symptoms and complications associated with the rare chronic liver disease. However, many patients with PBC have sustained serious liver injuries related to the use of ‘Ocaliva’ when taken at certain dosages. Over the past year, the Food and Drug Administration (FDA) has discovered that patients suffering from moderate to severe PBC are at risk of sustaining serious liver injuries when taking Ocaliva daily as opposed to weekly. Taking a large dose of Ocaliva may even put a patient at risk of suffering death.
FDA Requires New Boxed Warning for Ocaliva Showing Heightened Risk of Liver Injury
Because so many patients have sustained serious liver injuries directly related to improper dosing of Ocaliva, the FDA now requires a boxed warning on the drug’s label and medication guide (often known as a “black box” warning). The new strengthened warning directs doctors and patients to follow the label’s dosing instructions which indicate that patients with moderate to severe PBC should be taking ‘Ocaliva’ pursuant to a weekly dosing regimen, and not a daily dosing regimen.
Additionally, the FDA, as a condition of approval of Ocaliva, required Intercept Pharmaceuticals, Inc. to continue undergoing clinical trials with patients who have advanced PBC. The FDA indicates that the results of these clinical trials may not be available until 2023. Until more information is known about the link between Ocaliva and serious liver injuries in patients with PBC, the FDA’s heightened warning requirement is intended to make clear to health care providers that patients with moderate to severe PBC should be prescribed Ocaliva pursuant to a weekly dosing regimen.
FDA Recommendations for Doctors and Patients Taking Ocaliva for Primary Biliary Cholangitis (PBC)
The FDA, as part of issuing a new boxed warning for Ocaliva, recommends that health care providers follow the drug’s dosing regimen identified in the drug label. The dosing regimen is based on calculating a “Child-Pugh” score in patients with PBC who may be suffering from liver cirrhosis BEFORE beginning treatment with ‘Ocaliva’. The Child-Pugh classification will provide a patient with a specific classification and starting dosage in accordance with the dosing table provided in the drug’s label. Health care providers are also instructed to inform patients and their caregivers/family members about what symptoms may be associated with worsening liver function or a severe liver injury.
Additionally, the FDA recommends that health care providers routinely monitor patients with PBC who are taking ‘Ocaliva’ to determine if dosing should be adjusted and to ensure patients are undergoing routine testing and evaluation of their liver functions. Patients should report any adverse events associated with the use of Ocaliva for PBC to both their health care providers and the FDA.
Failing to Warn Doctors and PBC Patients About the Link Between Ocaliva and Severe Liver Injuries
Ocaliva was approved by the FDA two years ago on an accelerated basis on condition that Intercept Pharmaceuticals, Inc. continues to undergo testing and studies to identify all known side effects of the drug, some of which may be fatal. Because testing and studies are ongoing, the true risks of taking Ocaliva may not be fully known. However, drug manufacturers have a duty to ensure their products are safe and should know about the most severe risks of taking a drug before the drug hits the marketplace. While the Ocaliva drug label has always stated that patients with moderate to severe PBC should take ‘Ocaliva’ weekly, the label did not include any warning identifying the severe consequences for PBC patients who take the drug daily.
Because Intercept Pharmaceuticals, Inc. did not warn that certain PBC patients taking Ocaliva on a daily dosing regimen are at risk for sustaining serious liver injuries, many patients have already suffered significant liver injuries and death. When a particular side effect has the potential to cause serious injuries or death, such information needs to be made clear to the FDA, health care providers, and patients.
Find Out if You Have a Potential Ocaliva Chronic Liver Disease Lawsuit
The link between taking Ocaliva at certain dosages for the treatment of moderate to severe PBC and the development of serious liver injuries is not disputed. After all, the FDA has determined the risk of sustaining liver injuries is high enough to justify a new black box warning for ‘Ocaliva’. Patients taking Ocaliva for moderate to severe PBC may have a potential lawsuit if they have an identifiable liver injury. Symptoms associated with a serious liver injury include, but may not be limited to, the following:
- Yellow eyes or yellow skin;
- Stomach pain;
- Bloody or black stools;
- Coughing up blood;
- Loss of appetite;
- Fevers or chills;
- Difficulty urinating; and
- Mental changes (confusion, slurred speech, and mood swings, etc.)
It is important to understand that the FDA’s black box warning applies only to patients who are taking Ocaliva for the treatment of moderate to severe PBC. Additionally, the risk of serious liver injury appears to be linked to a particular dosage of ‘Ocaliva’. As such, the criteria for determining whether a person has a potential ‘Ocaliva’ lawsuit is limited to the reason for taking the drug as well as the dosage a person is taking. Because the process for evaluating a potential legal claim can be confusing, speaking with a qualified lawyer is the best way to find the answers you need.
Parker Waichman LLP – Our Lawyers Have Obtained More than $2 Billion for Clients
The nationally-recognized Defective Drug Lawyers of Parker Waichman LLP have recovered more than $2 billion in compensation collectively for clients through settlements and favorable trial verdicts. At Parker Waichman, LLP our trial lawyers handle much more than defective drug and medical device claims. We also handle many other personal injury matters including, among others, medical malpractice, auto accidents, workplace accidents, slip and fall accidents, and nursing home abuse and neglect. Because we have helped so many clients obtain compensation, our firm has received favorable ratings which include the following:
- 9.8/10 Rating by AVVO;
- “Preeminent Lawyers” AV Rating by Martindale-Hubbell;
- Ranking of “5 Dragons” by Lawdragon (the highest ranking available); and
- Listing in “Best Lawyers” Publication Established by Thorough Peer Review.
While we are honored to receive positive peer-reviewed ratings from the legal community, we still believe it is important that all potential clients call our office to learn more about what we do and how we help so many clients fight to receive the compensation they deserve.
Contact an Ocaliva Chronic Liver Disease Lawsuit Lawyer Today to Schedule Your Free Consultation
If you have sustained serious liver damage after taking ‘Ocaliva’ for chronic liver disease, you should consider how an experienced Ocaliva Chronic Liver Disease Lawsuit Lawyer may be able to help you. At Parker Waichman LLP, our nationally-recognized trial lawyers devote their time and energy to helping clients receive compensation for their injuries and suffering. To receive your free consultation, contact our law office today by calling (800) YOUR-LAWYER (968-7529).
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