"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"...
Overdosages of up to 14.4 g have been reported in the literature. No fatalities have been reported and all overdosed patients recovered without sequelae. There is no specific antidote for a thalidomide overdose. In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure and respiratory status.
[see BOXED WARNING]
THALOMID can cause fetal harm when administered to a pregnant female [see WARNINGS AND PRECAUTIONS and Use in Specific Populations.] Thalidomide is contraindicated in females who are pregnant. Thalidomide is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose [see BOXED WARNING]. Mortality at or shortly after birth has been reported in about 40% of infants. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. If pregnancy occurs during thalidomide treatment, the drug should be discontinued immediately.
THALOMID is contraindicated in patients who have demonstrated hypersensitivity to the drug or its components [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.
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