New FDA Approvals
The FDA has recently approved the following drugs:
- Pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) by Hameln Pharmaceuticals, GmbH, of Hameln, Germany. The FDA has approved two drugs, pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) for treating certain kinds of radiation contamination. The FDA has determined that pentetate calcium trisodium injection and pentetate zinc trisodium injection are safe and effective for treating internal contamination with plutonium, americium, or curium. The drugs increase the rate of elimination of these radioactive materials from the body.
Pentetate calcium trisodium injection and pentetate zinc trisodium injection should not be administered simultaneously. If both products are available, pentetate calcium trisodium injection should be given as the first dose. If additional treatment is needed, treatment should be switched to pentetate zinc trisodium injection. This treatment sequence is recommended because pentetate calcium trisodium injection is more effective than pentetate zinc trisodium injection during the first 24 hours after internal contamination.
After the initial 24 hours, pentetate zinc trisodium injection and pentetate calcium trisodium injection are similarly effective. Pentetate calcium trisodium injection and pentetate zinc trisodium injection usually are administered into the blood stream. However, in people whose contamination is only by inhalation, pentetate calcium trisodium injection or pentetate zinc trisodium injection can be administered by nebulized inhalation.
The main side effect of pentetate calcium trisodium injection is the loss of certain essential nutritional metals such as zinc, which can be replaced by taking oral zinc supplements. In addition, breathing difficulties have been noted in some individuals treated by inhalation therapy with these products.
Pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) by Hameln Pharmaceuticals, GmbH, of Hameln, Germany.
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