Law Offices of Thomas J. Lamb

  • About Firm
  • Practice Areas
  • Free Case Evaluation
  • Quick Contact Form
  • Frequently Asked Questions
  • Attorney Tom Lamb

Ocaliva Drug Label Warnings vis-à-vis FDA Ocaliva Safety Signal Investigation

October 19, 2020 By Law Offices of Thomas J. Lamb, P.A.

In our last article, we reported on the current FDA investigation of an Ocaliva safety signal which, although it began in May 2020, only became public knowledge in October. The best we can tell, it is a possible Ocaliva liver toxicity issue that is the subject of this Ocaliva FDA investigation.

Now we have some additional information about some hepatobiliary events (i.e., involving liver, gallbladder, bile ducts, or bile) which might have given rise to this Ocaliva safety signal. From an October 13, 2020 news report, “Shedding light on Intercept’s opaque disclosure”, published by Evaluate Vantage, we get these details:

[The safety database Advera Health Analytics] which gets its data from the FDA’s FAERS adverse event reporting system and adjusts for a number of factors to add context and remove duplication, shows several active liver toxicity signals not already cited on Ocaliva’s label.

These include liver failure and portal hypertension, all derived from adverse event reporting from in-market use of Ocaliva for [treatment of a rare chronic liver disease, primary biliary cholangitis (PBC)]….

One caveat is that all of these issues could be related to the underlying disease, since PBC affects the liver, but the higher the [risk odds ratio (ROR)] the less likely it seems that this would explain away the adverse event seen.

We are investigating possible Ocaliva drug injury lawsuits that would be filed against Intercept Pharmaceuticals, the responsible drug company, for patients who have been diagnosed with these serious possible Ocaliva side effects:

  • Chronic hepatic failure
  • Portal hypertension
  • Hepatic failure
  • Hepatorenal syndrome
  • Autoimmune hepatitis

Of course, while we watch for findings from the FDA investigation of an Ocaliva safety signal, we will continue to monitor the medical and regulatory realms for significant developments regarding this Ocaliva liver toxicity issue.

[View article at original source]

Ocaliva

Free Case Evaluation

Strictly Confidential, No Obligation

Filed Under: Unsafe Drugs Tagged With: liver damage, liver failure, liver injury, Ocaliva

Find What You Want Here

Get Free Case Evaluation

We encourage you to submit an online Case Evaluation Form – it is confidential and there is no obligation.

Or call our toll-free number, 800-426-9535, to speak directly to attorney Tom Lamb about your possible case.

Feel Free To Contact Us

Quick Contact Form
 
Send an Email to Tom Lamb

(800) 426-9535

Main Navigation Menu

  • About Firm
  • Asbestos-Mesothelioma Cases
  • Benzene Disease Claims
  • PFAS Firefighter Gear Lawsuits
  • Camp Lejeune Cases
  • GenX Water Cancer Cases
  • Drug Injury Lawsuits
  • Breast Implant Cancer Cases
  • Philips Breathing Devices Cases
  • Case Evaluation Menu
  • Quick Contact Form
  • Frequently Asked Questions
  • Medical Records Charges
  • Collection of Articles
  • Sitemap

Lamb Law Office Newsletter

Lamb Law Office Newsletter provides periodic updates about some of the cases that we are working on for clients, as well as an information resource you might find helpful.

Subscribe using Form below.

Subscription Form

* indicates required

Our Other Websites

Drug Injury Law
Drug Injury Watch
Drug Safety Developments
Asbestos & Mesothelioma

Contact Information

Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com

  • Home
  • Disclaimer and Copyright Notices
  • Sitemap

Copyright © 2023 · Law Offices of Thomas J. Lamb, P.A.