"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Because of its action in the clotting mechanism, THROMBIN-JMI (thrombin topical bovine origin) ® must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.
Consult the Absorbable Gelatin Sponge, USP labeling for complete information for use prior to utilizing the thrombin saturated sponge procedure.
Category C — Animal reproduction studies have not been conducted with THROMBIN-JMI (thrombin topical bovine origin) ®. It is also not known whether THROMBIN-JMI (thrombin topical bovine origin) ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBIN-JMI (thrombin topical bovine origin) ® should be given to a pregnant woman only if clearly indicated.
Safety and effectiveness in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/14/2008
Additional Thrombin-JMI Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.