Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) shares tumbled on Thursday after it came to light that the U.S. Food and Drug Administration (FDA) had issued a warning about the firm’s liver disease medicine Ocaliva (obeticholic acid). This warning comes on the heels of 19 cases of death related to the drug.

As we have said before, updates from the FDA have the potential to make or break a company. In this case it seems like a mild setback, but further complications could prove to be catastrophic.

The FDA said 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 and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them.

Although it goes further than potential incorrect dosing. Ocaliva also may be associated with liver injury in some patients with mild disease who are receiving the correct dose.

For some quick background: Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC). PBC causes the bile ducts in the liver to become inflamed, damaged and destroyed. And in the 13 months after Ocaliva was approved in May 2016, the FDA received reports of serious liver injury or death associated with Ocaliva.

The FDA said in its release:

Nineteen cases of death were identified, of which eight provided information about the patient’s cause of death. The cause of death was reported to be worsening of PBC disease in seven cases, with cardiovascular disease cited in the other case. Seven of these eight cases described patients with moderate to severe decreased liver function who received Ocaliva 5 mg daily, instead of a dose no greater than 10 mg twice weekly as recommended in the label prescribing information for patients with this extent of decreased liver function.

Shares of Intercept were last seen down 11% at $87.35, with a consensus analyst price target of $186.94 and a 52-week range of $85.88 to $172.75.

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