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
- Abdominal pain
- Nausea and vomiting
- Bleeding that does not stop after a few minutes
- Unusual swelling in hands and feet
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