Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Risk of Extravasation and Tissue Damage (and Tissue Damage added)
- Addition of: Confirm intravenous patency before injection.
Postmarketing Experience (addition)
- The following adverse reactions have been identified during post-approval use of Thallous Chloride Tl 201. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Injection site reactions and extravasation of Tl-201 have been reported: burning, pain, redness, swelling, warmth, and, in one case, tissue damage with chronic ulcer formation.
- The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.