Regulators have issued Doctors and Hospitals with a warning over Intercept Pharmaceuticals liver disease drug after 19 people have reportedly died after taking too much of it.
Regulators also noted 11 cases of serious liver injury after taking the drug as well.
The warning prompted the company’s shares to reportedly plummet down by 24.9%, to $73.70. The drop is thought to be the company’s biggest loss since November 2014, Bloomberg reports.
The regulator warning said that the drug, “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”.
It has also been reported that some patients with mild liver disease who are receiving the correct dose also suffered liver injury, indicating that the problem could lie with the medication itself, rather than just an overdose.
The liver is a vital organ that primarily filters toxins from the blood before it makes its way to the rest of the body. It detoxifies chemicals and metabolises drugs, helping to keep our body’s toxin free.
Those suffering with liver disease and reduced liver function may not be able to do this as effectively. This kind of drug is, therefore, very important to those with liver problems.
Ocaliva is used to treat a rare liver disease called Primary Biliary Cholangitis (PBC). This condition can inflame, damage and destroy bile ducts, which can lead to a build-up of bile that can block up the liver. This can stop the liver from working effectively in filtering out toxins in our blood. Ocaliva works by reducing alkaline phosphatase linked to PCB, and the drug was notably only approved last year.
At the moment, Ocaliva does not list death as one of its risks. We wonder whether Intercept will need to recall the drug to adjust its formula, or at least to relabel it to include the fatal risk, and perhaps consider whether the drug is more dangerous than anticipated.
The Medicines and Healthcare products Regulatory Agency (MHRA) has yet to make any statement over Ocaliva, which is distributed in the U.K. The drug received approval from the National Institute for Health and Care Excellence (NICE) for routine use by our NHS in March 2017. Intercept’s President, Lisa Bright, reportedly praised NICE’s “very rapid decision” to approve the drug.
According to Symphony Health Solutions, around 15,000 prescriptions for Ocaliva have been made since it was approved and hit the market.
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