Ocaliva Liver Damage
New studies show that the liver disease drug Ocaliva could have previously unheard of health hazards. The medication is still new on the market. However, there are still risks to this drug.
Approved by the FDA in 2016, Ocaliva (obeticholic acid) is a medication for the treatment of primary biliary cholangitis (PBC) or help those who cannot tolerate ursodeoxycholic acid (UDCA). PBC is a rare chronic liver disease. Ocaliva is a medication that uses a chemical substance with a structure that binds to naturally occurring bile acid. This binding prevents the buildup of bile, which can damage the liver’s ability to function over time.
FDA Concerns About Ocaliva Liver Damage
In September of 2017, the FDA issued an emergency health communication after 19 patients taking Ocaliva died and at least 11 others developed liver disease. The release advised consumers that excessive doses of the drug may result in serious liver injury or death. However, the FDA also warns that Ocaliva could cause liver damage with correct dosage, too. Physicians should monitor patients and discontinue if any liver injury presents.
Only seven of the fatalities had a cause of death listed. The report indicated worsening of primary biliary cholangitis. It is unknown the exact cause of death. The FDA suspects overdosage since the starting dose is 5 mg with a weekly max of 20mg. Many patients reported taking 5 mg daily. This equals 15 mg over the weekly recommended maximum dosage. Currently, there is no evidence to support this hypothesis. Intercept announced that the company will work with the FDA to update the label.
Ocaliva Side Effects
The main side effect of Ocaliva is liver injury, tissue death in the liver and liver failure.
The early warning signs of liver injury are:
- Rapid heart rate
- Rapid breathing
- Cold, clammy, pale or bluish skin
- Abdominal pain and tenderness
- Abdomen may be swollen
We Want to Help Ocaliva Victims
Undeniably, it is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one took Ocaliva and suffered drug-induced liver injury, you should demand accountability. We want to also help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A verdict or settlement may give you compensation for their injuries and damages. The types of recoverable losses are:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Also, if a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages. These damages aim to punish the company and deter similar conduct in the future. Therefore, if you suffered drug-induced liver injury from Ocaliva, please speak to us to learn more about your rights.