Doptelet Approved for Liver Disease Patients Slated for a Medical Procedure
MONDAY, May 21, 2018 -- Doptelet (avatrombopag) has been approved by the U.S. Food and Drug Administration to treat adults with chronic liver disease who are slated to have a medical or dental procedure.
People with ongoing liver disease often have low blood platelet count, which raises their risk for dangerous bleeding during a medical procedure, the agency said Monday in a news release.
"This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions," said Dr. Richard Pazdur, director of the agency's Oncology Center of Excellence.
The drug was evaluated in a pair of clinical studies involving a total of 435 people with chronic liver disease and low blood platelets. The most common side effects included fever, stomach pain, nausea, headache, fatigue, and swelling of the hands or feet. An elevated risk of blood-clot formation was a less common but more serious adverse reaction, the FDA said.
The drug is produced by the Japanese pharma firm AkaRx.
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Posted: May 2018