Promacta Linked to Severe Liver Damage and Hepatotoxicity

August 30, 2016 — Health Canada has issued a warning about the risk of severe liver damage from Promacta (eltrombopag).

Promacta was approved by the FDA in August 2015 to treat low blood platelet count in patients with a rare blood disorder. It is also sold under the brand-name Revolade in Canada and Europe.

Health Canada warns that it can cause severe hepatotoxicity and potentially fatal liver injury. Investigators found 5 cases of severe drug-induced liver injury in patients during clinical trials and post-marketing.

Liver problems typically occurred within 3 months of starting Promacta and resolved after the drug was discontinued. In clinical trials, 1% of patients with hepatitis C who were treated with Promacta (11 patients) experienced drug-induced liver damage.

Patients must have blood tests to check liver function before starting Promacta. Liver function should be checked every 2 weeks during the dose-adjustment phase, and monthly after establishing a stable dose.

In Canada, the label was updated with stronger warnings about hepatotoxicity. In addition, the agency prohibits continuing the drug in patients with pre-existing liver disease who develop elevated liver enzyme levels.

Hepatotoxicity is a medical term for drug-induced liver damage. It can cause short-term and long-term liver problems, including fatal liver failure.

Symptoms of hepatotoxicity include:

• Jaundice (yellowing of skin and eyes)
• Severe fatigue
• Fever
• Abdominal pain
• Nausea and vomiting
• Bleeding that does not stop after a few minutes
• Unusual swelling in hands and feet

Need a Drug Injury Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas drug injury lawyers for a free lawsuit review.