Skip to main content


Generic name: human thrombin
Drug class: Miscellaneous coagulation modifiers
Approval date: August 27, 2007
Company: Omrix Biopharmaceuticals, Ltd.

Medically reviewed by Last updated on Aug 23, 2023.

Treatment for: Bleeding

FDA Approves Evithrom

The U.S. Food and Drug Administration has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Highlights of Evithrom Prescribing Information

These highlights do not include all the information needed to use Evithrom safely and effectively.

Indications and Usage

Dosage and Administration

Dosage Forms and Strengths


Warnings and Precautions

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at (877) 384-4266 or FDA at 1-800-FDA-1088 or

Use in Specific Populations

Patient Counseling Information

Some viruses such as hepatitis A virus and parvovirus B19 are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include: fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear. If absorbed systemically Evithrom could potentially cause blood clotting disorders. Patients should be encouraged to consult their physician for any new or unusual symptoms.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.