"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
(Generic versions may still be available.)
IT IS RECOMMENDED THAT MITHRACIN (plicamycin) BE ADMINISTERED ONLY TO HOSPITALIZED PATIENTS BY OR UNDER THE SUPERVISION OF A QUALIFIED PHYSICIAN WHO IS EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS, BECAUSE OF THE POSSIBILITY OF SEVERE REACTIONS. FACILITIES FOR THE DETERMINATION OF NECESSARY LABORATORY STUDIES MUST BE AVAILABLE.
SEVERE THROMBOCYTOPENIA, A HEMORRHAGIC TENDENCY AND EVEN DEATH MAY RESULT FROM THE USE OF MITHRACIN (plicamycin) . ALTHOUGH SEVERE TOXICITY IS MORE APT TO OCCUR IN PATIENTS WHO HAVE FAR-ADVANCED DISEASE OR ARE OTHERWISE CONSIDERED POOR RISKS FOR THERAPY, SERIOUS TOXICITY MAY ALSO OCCASIONALLY OCCUR EVEN IN PATIENTS WHO ARE IN RELATIVELY GOOD CONDITION.
IN THE TREATMENT OF EACH PATIENT, THE PHYSICIAN MUST WEIGH CAREFULLY THE POSSIBILITY OF ACHIEVING THERAPEUTIC BENEFIT VERSUS THE RISK OF TOXICITY WHICH MAY OCCUR WITH MITHRACIN (plicamycin) THERAPY. THE FOLLOWING DATA CONCERNING THE USE OF MITHRACIN (plicamycin) IN THE TREATMENT OF TESTICULAR TUMORS, HYPERCALCEMIC AND/OR HYPERCALCIURIC CONDITIONS ASSOCIATED WITH VARIOUS ADVANCED MALIGNANCIES, SHOULD BE THOROUGHLY REVIEWED BEFORE ADMINISTERING THIS COMPOUND.
General: Mithracin (plicamycin) should be administered only to patients who are hospitalized and who can be observed carefully and frequently during and after therapy.
Severe thrombocytopenia, a hemorrhagic tendency and even death may result from the use of Mithracin (plicamycin) . Although severe toxicity is more apt to occur in patients who have far-advanced disease or are otherwise considered poor risks for therapy, serious toxicity may also occasionally occur even in patients who are in relatively good condition.
In the treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit versus the risk of toxicity which may occur with Mithracin (plicamycin) therapy.
Laboratory Tests: The following laboratory studies should be obtained frequently during therapy and for several days following the last dose: platelet count, prothrombin time, bleeding time. The occurrence of thrombocytopenia or a significant prolongation of prothrombin time or bleeding time is an indication for the termination of therapy.
Carcinogenesis, mutagenesis, impairment of fertility: No long-term studies in animals have been performed to evaluate the carcinogenic potential of Mithracin (plicamycin) . Histologic evidence of inhibition of spermatogenesis was observed in a substantial number of male rats receiving doses of 0.6 mg/ kg/day and above.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Mithracin (plicamycin) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Mithracin Information
Report Problems to the Food and Drug Administration
Get the latest treatment options.