"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"...
A very high percentage of patients treated with LYSODREN have shown at least one type of side effect. The main types of adverse reactions consist of the following:
- Gastrointestinal disturbances, which consist of anorexia, nausea or vomiting, and in some cases diarrhea, occur in about 80% of the patients.
- Central nervous system side effects occur in 40% of the patients. These consist primarily of depression as manifested by lethargy and somnolence (25%), and dizziness or vertigo (15%).
- Skin toxicity has been observed in about 15% of the cases. These skin changes consist primarily of transient skin rashes which do not seem to be dose related. In some instances, this side effect subsided while the patients were maintained on the drug without a change of dose.
Infrequently occurring side effects involve the eye (visual blurring, diplopia, lens opacity, toxic retinopathy); the genitourinary system (hematuria, hemorrhagic cystitis, and albuminuria); cardiovascular system (hypertension, orthostatic hypotension, and flushing); and some miscellaneous effects including generalized aching, hyperpyrexia, and lowered protein bound iodine (PBI).
The following additional adverse reactions have been identified during postapproval use of LYSODREN. Because reports are voluntary from a population of unknown size, an estimate of frequency cannot be made.
Blood and lymphatic system disorders: neutropenia
Endocrine disorders: growth retardation, hypothyroidism
Psychiatric disorders: confusional state
Eye disorders: maculopathy
Hepatobiliary disorders: hepatitis, elevation of liver enzymes
Reproductive system and breast disorders: gynecomastia
General disorders and administration site conditions: asthenia
Investigations: blood uric acid decreased, blood cholesterol increased, blood triglycerides increased
Read the Lysodren (mitotane) Side Effects Center for a complete guide to possible side effects
LYSODREN is a strong inducer of cytochrome P-450 3A4 (CYP3A4). Monitor patients for a change in dosage requirements for the concomitant drug when administering LYSODREN to patients receiving drugs that are substrates of CYP3A4.
LYSODREN's CYP induction effect leads to an increase in dosage requirements for warfarin. Closely monitor patients for a change in anticoagulant dosage requirements when administering LYSODREN to patients receiving coumarin-type anticoagulants.
Read the Lysodren Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.
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