⛔ FDA Black Box Warning
WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY Nebulized Zn-DTPA may be associated with asthma exacerbation. ( 5.1 ) Zn-DTPA is associated with depletion of trace metals. The risk for depletion increases when Zn-DTPA is administered over several months. Monitor serum zinc levels, serum creatinine, BUN, electrolytes, urinalysis and blood cell counts during Ca-DTPA or Zn-DTPA therapy. ( 2.4 , 5.2 ) WARNING: ASTHMA EXACERBATION WITH NEBULIZATION and DEPLETION OF TRACE METALS DURING THERAPY See full prescribing information for complete boxed warning. Nebulized Zn-DTPA may be associated with asthma exacerbation. ( 5.1 ) Zn-DTPA is associated with depletion of trace metals. The risk for depletion increases when Zn-DTPA is administered over several months. Monitor serum zinc levels, serum creatinine, BUN, electrolytes, urinalysis and blood cell counts during Ca-DTPA or Zn-DTPA therapy. ( 2.4 , 5.2 )
Pregnancy & Breastfeeding
8.1 Pregnancy Pregnancy Category B Risk Summary There are no adequate and well-controlled studies of Zn-DTPA use in pregnant women. Chelation treatment of pregnant women should begin and continue with Zn-DTPA. Reproduction studies have been performed in pregnant mice at doses up to 31 times (11.5 mmol/kg) the recommended daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Zn-DTPA. There was a slight reduction in the average birth weight. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.