FDA Issues a Safety Warning About Injuries and Death from Intercept’s Liver Drug Ocaliva

The U.S. Food and Drug Administration (FDA) has issued a drug safety communication regarding serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease. The warning communicates concern that the drug is not being dosed correctly in some patients who have moderate to severe decrease in liver function, which has resulted in an increased risk of serious liver injury and death according to the FDA.

Ocaliva was approved by the FDA in May 2016 for the treatment of a rare liver disease, primary biliary cholangitis (PBC). In the 13 months since the drug has been approved to treat the chronic liver disease, 19 deaths have been reported. In seven of the death cases, worsening of PBC disease was cited as the cause of death, and several patients had been receiving Ocaliva 5mg daily instead of the correct dose of no greater than 10mg weekly according to a story in Pharma Times. The FDA has also identified 11 cases of serious liver disease caused by use of Ocaliva.

The FDA safety communication advices health care professionals to determine the patient’s baseline liver function before they begin taking Ocaliva, and patients should contact their health care professional if they have questions or concerns about taking Ocaliva. If you are taking Ocaliva and notice any of the following signs of liver injury, you should contact your doctor immediately:

• New or worsening fatigue
• Diarrhea
• Weight loss
• Abdominal pain
• Decreased appetite
• Nausea and vomiting
• Change in behavior or confusion
• Vague symptoms such as anxiety or unease
• Abdominal swelling
• Yellow eyes or skin
• Bloody stools

The next step in FDA’s oversight could be to issue a “black box” warning, which is the most severe warning they can issue for drug because it implies that a drug has serious or life-threatening risks.

Dangerous drugs

The U.S. Centers for Disease Control and Prevention (CDC) reports that pharmaceutical drugs kill more than 40,000 people each year in the U.S. More than 50% of the drugs that are marketed to Americans have some injurious effects despite testing and FDA approval.

Drug manufacturers are liable for the injuries their defective drugs might cause to the end consumer whether they were aware of the danger or not. Consumers who suffer injuries and those who have lost loved ones because of a dangerous drug may be able to take legal action against the drug manufacturer to recover compensation for their injuries. There are some drugs that have life-saving benefits for those who take them, but other drugs may cause more harm than good. If the medication you are taking to treat a medical condition is causing you harm, you may have a valid claim. Talk to a defective drug attorney right away and discover your legal options.

The team at McGowan, Hood, Felder & Phillips, LLC, wants to help you hold any negligent manufacturer and seller of dangerous or defective drugs, fully liable for physical harm, emotional suffering, and wrongful death they have caused. You are welcome to schedule an appointment to speak with us by calling 803-327-7800 or completing our contact form today.