April 26, 2018


OCALIVA is a drug manufactured by Intercept Pharmaceuticals, Inc., that was first approved by the Food & Drug Administration on May 27, 2016, for the treatment of primary biliary cholangitis (PBC) in combination with urodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or for adults who are unable to tolerate UDCA. OCALIVA was approved through the accelerated approval process wherein OCALIVA was required to undergo clinical trials after its approval to establish the describe clinical benefit of the drug. No improvement in the survival or disease related symptoms had been established for OCALIVA at the time of product launch. The accelerated approval letter for OCALIVA includes additional post marketing requirements with very specific deadlines to for the manufactures of OCALIVA to accomplish addition studies on the drug.


Primary Biliary Cholangitis (PBC) is a chronic liver disease wherein bile ducts in the liver are destroyed and bile cannot flow from the liver to small intestines to help in with digestion. It is most frequently seen in woman 40s-60s.


On September 21, 2017, the FDA sent out a safety notice to pharmacies, hepatologist, and gastroenterologist warning that OCALIVA is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury or death. The safety notice went on to say [t]hese patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label. The recommendations from the FDA recommended that doctors should determine a patient’s baseline liver function prior to starting Ocaliva, and patients with moderate to server liver impairment should be started on 5 mg once weekly instead of 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly.


In January 2018, Intercept released a second label for OCALIVA that include a BLACK BOX WARNING stating that there have been postmarketing reports of liver failure, including deaths, in patients with PBC patients with decompensating cirrhosis or Child-Pugh Class B or C liver impairments when OCALIVA was dosed more frequently than recommended. It then went on to emphasize the recommended starting dosage for OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C liver impairments or prior decompensation events.

This new January 2018 label had a significantly more detailed and extensive DOSAGE AND ADMINISTRATION section than the prior label.


The FDA issues a second safety alert regarding the new OCALIVA BLACK BOX WARNING to highlight correct dosing for patients. The alert stated that OCALIVA has been incorrectly dosed daily instead of weekly in patients with moderate to severe PBC, increasing the risk of serious liver injury.


An important question that needs to be answered is why were patients with moderate to severe PBC receiving the incorrect dosing from doctors? Is it because the 2016 OCALIVA label failed to warn or highlight the correct dosing for these patients? Was the 2016 OCALIVA labeling confusing for doctors? Did the 2016 OCALIVA labeling fail to include known warning information that is found in the subsequent 2018 OCALIVA label? Did any of these potential warnings issues lead to liver injuries or deaths? These are all issues that need to be investigated.


For two decades, the attorneys at Vickery & Shepherd have represented individuals and their families who have been injured by pharmaceuticals and medical devices. If you or your loved one has suffered liver injury or death that you believe is due to OCALIVA, please contact us at 713-526-1100.