Tennessee Ocaliva Lawyer
Primary biliary cholangitis (PBC) is a rare but serious chronic liver disease. PBC refers to the destruction of bile ducts in the liver. These bile ducts are necessary to digest fat and certain critical vitamins. When PBC destroys the ducts, it can scar the liver tissue and ultimately lead to cirrhosis.
In May 2016, the U.S. Food and Drug Administration approved Ocaliva, also known by the generic name obeticholic acid, as a treatment for PBC. But just 13 months later, the FDA issued a “Drug Safety Communication” warning doctors and patients about the potential for serious liver injury caused by Ocaliva. Despite this warning the manufacturer of Ocaliva, Intercept Pharmaceuticals, has not recalled or withdrawn the drug from the market.
If you have been injured or lost a family member due to PBC and suspect Ocaliva may have played a role, you may be entitled to compensation. The Tennessee Ocaliva attorneys at Fox & Farley can sit down with you and review your specific case history to help you decide whether it is in your best interests to file a claim.
Ocaliva Tied to Multiple Patient Deaths, Serious Liver Injuries
According to the FDA, there are at least 19 patients who died after taking Ocaliva for treatment of PBC. In the 8 cases where a cause of death was clearly identified, 7 died due to a “worsening of PBC disease.” The eighth patient died from cardiovascular disease.
The FDA also identified 11 cases where patients sustained “serious liver injury” due to Ocaliva. Three of these patients were among the 19 dead mentioned above. They were among a group of 6 patients who experienced “moderate or severe decreased in liver function” while taking a higher-than-recommended dose of Ocaliva.
Although the FDA suspects such overdoses may the primary cause of Ocaliva-related liver damage, this remains speculation. The FDA has yet to take any additional action against Ocaliva and Intercept. And it is possible that reports of overdosing are simply an attempt to shift the blame to doctors and patients for a serious defect in the drug itself.
Speak with Our Tennessee Ocaliva Litigation Team Today
Ocaliva is still a relatively new drug and there is much we do not know about its long-term side effects on users. According to Intercept’s own labeling, the presently known side effects of Ocaliva include severe itching and decreases in HDL-C cholesterol.
If you have suffered personal injury after using Ocaliva, or if you believe that the drug may be the responsible for the death of a family member who had PBC, you should contact Fox & Farley, Attorneys at Law, at (866) 862-4855. A member of our legal team will schedule a free consultation so we can sit down and review the specifics of your case, as well as discuss your options for potential legal action against Intercept Pharmaceuticals.
Fox & Farley serves clients in Tennessee cities such as Knoxville, Clinton, Oak Ridge, Kingston, La Follette, Maryville, Sevierville, Pigeon Forge, Gatlinburg and others throughout Knox County, Anderson County, Roane County, Macon County, Blount County, Campbell County, Claiborne County, Morgan County, Scott County, Sevier County, and Union County.