"The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient's risk of future coronary heart disease (CHD) events, such as heart attacks.
FDA cleared the test for use in all adults with no history of hear"...
Thallous Chloride Tl-201 Injection
When studying patients suspected or known to have myocardial infarction or ischemia, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedures. Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.
Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling.
Data are not available concerning the effect on the quality of Thallous Chloride Tl-201 images of marked alterations in blood glucose, insulin or pH (such as is found in diabetes mellitus). Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the Thallous Chloride Tl-201 may likewise be affected.
This drug should not be used after six (6) days from the calibration date, or nine (9) days from date of manufacture, whichever comes first.
As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper management and to insure minimum radiation exposure to occupational workers.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.
Pregnancy Category C
Animal reproductive studies have not been conducted with Thallous Chloride Tl-201. It is also not known whether Thallous Chloride Tl-201 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Thallous Chloride Tl-201 should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, as a general rule nursing should not be undertaken when a patient is administered radioactive material.
Safety and effectiveness in pediatric patients below age 18 have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/21/2008
Additional Thallous Chloride Tl-201 Injection 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.
Get the latest treatment options.