"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
In the U.S. Registry, a total of 646 individuals received at least one dose of either Ca-DTPA (pentetate calcium trisodium inj) or Zn-DTPA. Of these, 632 received Ca-DTPA (pentetate calcium trisodium inj) by one or more routes of administration. Three hundred and twenty-six individuals were dosed by inhalation, 293 by intravenous injection, and 60 by other or unknown routes of administration.
Of the individuals that received Ca-DTPA (pentetate calcium trisodium inj) , 393/632 (62%) received one dose and 65 (10%) received two doses. The remaining 174 individuals received three or more doses. The largest number of Ca-DTPA (pentetate calcium trisodium inj) doses to a single individual was 338 delivered over 6.5 years. Overall, the presence or absence of adverse events was recorded in 310/646 individuals. Of these 19 (6.1%) individuals reported at least one adverse event. The total number of recorded adverse events was 20. Of the 20 adverse events, 18 adverse events occurred after treatment with Ca-DTPA (pentetate calcium trisodium inj) . Adverse events included headache, lightheadedness, chest pain, allergic reaction, dermatitis, metallic taste, nausea and diarrhea, and injection site reactions.
Read the Ca-DTPA (pentetate calcium trisodium inj) Side Effects Center for a complete guide to possible side effects
Adequate and well-controlled drug-drug interaction studies in humans were not identified in the literature. When an individual is contaminated with multiple radiocontaminants, or when the radiocontaminants are unknown, additional therapies may be needed (e.g., Prussian blue, potassium iodide).
Last reviewed on RxList: 1/7/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Ca-DTPA Information
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