The Basics
What is Chromium Cr 51 Edetate?
Indicated for the determination of glomerular filtration rate in the assessment of renal function.
Brand names for Chromium Cr 51 Edetate
Lyrica Cr
How Chromium Cr 51 Edetate is classified
Radiopharmaceuticals, Chromium Radioisotopes, Diagnostic Agents
Chromium Cr 51 Edetate During Pregnancy
Chromium Cr 51 Edetate pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Chromium Cr 51 Edetate while pregnant
No information available. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pregnancy. To provide information regarding the effects of in utero exposure to LYRICA CR, physicians are advised to recommend that pregnant patients taking LYRICA CR enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate and well-controlled studies with LYRICA CR in pregnant women. However, in animal reproduction studies, increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including skeletal malformations, retarded ossification, and decreased fetal body weight were observed in the offspring of rats and rabbits given pregabalin orally during organogenesis, at doses that produced plasma pregabalin exposures (AUC) greater than or equal to 18 times human exposure at the maximum recommended dose (MRD) of 660 mg/day . In an animal development study, lethality, growth retardation, and nervous and reproductive system functional impairment were observed in the offspring of rats given pregabalin during gestation and lactation. The no-effect dose for developmental toxicity was approximately twice the human exposure at MRD. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Advise pregnant women of the potential risk to a fetus. Data Animal Data When pregnant rats were given pregabalin (500, 1250, or 2500 mg/kg) orally throughout the period of organogenesis, incidences of specific skull alterations attributed to abnormally advanced ossification (premature fusion of the jugal and nasal sutures) were increased at greater than or equal to 1250 mg/kg, and incidences of skeletal variations and retarded ossification were increased at all doses. Fetal body weights were decreased at the highest dose. The low dose in this study was associated with a plasma exposure (AUC) approximately 18 times human exposure at the MRD of 660 mg/day. A no-effect dose for rat embryo-fetal developmental toxicity was not established. When pregnant rabbits were given pregabalin (250, 500, or 1250 mg/kg) orally throughout the period of organogenesis, decreased fetal body weight and increased incidences of skeletal malformations, visceral variations, and retarded ossification were observed at the highest dose. The no-effect dose for developmental toxicity in rabbits (500 mg/kg) was associated with a plasma exposure approximately 17 times human exposure at the MRD. In a study in which female rats were dosed with pregabalin (50, 100, 250, 1250, or 2500 mg/kg) throughout gestation and lactation, offspring growth was reduced at greater than or equal to 100 mg/kg and offspring survival was decreased at greater than or equal to 250 mg/kg. The effect on offspring survival was pronounced at doses greater than or equal to 1250 mg/kg, with 100% mortality in high-dose litters. When offspring were tested as adults, neurobehavioral abnormalities (decreased auditory startle responding) were observed at greater than or equal to 250 mg/kg and reproductive impairment (decreased fertility and litter size) was seen at 1250 mg/kg. The no-effect dose for pre-and postnatal developmental toxicity in rats (50 mg/kg) produced a plasma exposure approximately 2 times human exposure at the MRD. In the prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures greater than or equal to 50 times the mean human exposure (AUC (0–24) of 123 μg•hr/mL) at the MRD.
Taking Chromium Cr 51 Edetate While Breastfeeding
What are recommendations for lactation if you're taking Chromium Cr 51 Edetate?
Information in this record refers to the use of chromium Cr 51 edetate (Cr 51-ethylenediamine tetraacetic acid; Cr 51-EDTA) as a diagnostic agent for the estimation of glomerular filtration rate. The International Commission on Radiological Protection and other experts state that breastfeeding need not be interrupted after administration of Cr 51 edetate.[1][2] The United States Nuclear Regulatory Commission states that breastfeeding need not be interrupted after administration of Cr 51 edetate in doses of 60 MBq (1.6 mCi) or less to a nursing mother.[3] However, to follow the principle of keeping exposure as low as reasonably achievable , some experts recommend nursing the infant just before administration of the radiopharmaceutical and interrupting breastfeeding for 2 to 6 hours after the dose, then expressing the milk completely once and discarding it. If the mother has expressed and saved milk prior to the examination, she can feed it to the infant during the period of nursing interruption.[4][5][6] Mothers concerned about the level of radioactivity in their milk could ask to have it tested at a nuclear medicine facility at their hospital. When the radioactivity is at a safe level she may resume breastfeeding. A method for measuring milk radioactivity and determining the time when a mother can safely resume breastfeeding has been published.[7]
Maternal / infant drug levels
Information in this record refers to the use of chromium Cr 51 edetate (Cr 51-ethylenediamine tetraacetic acid; Cr 51-EDTA) as a diagnostic agent for the estimation of glomerular filtration rate. The International Commission on Radiological Protection and other experts state that breastfeeding need not be interrupted after administration of Cr 51 edetate.[1][2] The United States Nuclear Regulatory Commission states that breastfeeding need not be interrupted after administration of Cr 51 edetate in doses of 60 MBq (1.6 mCi) or less to a nursing mother.[3] However, to follow the principle of keeping exposure as low as reasonably achievable , some experts recommend nursing the infant just before administration of the radiopharmaceutical and interrupting breastfeeding for 2 to 6 hours after the dose, then expressing the milk completely once and discarding it. If the mother has expressed and saved milk prior to the examination, she can feed it to the infant during the period of nursing interruption.[4][5][6] Mothers concerned about the level of radioactivity in their milk could ask to have it tested at a nuclear medicine facility at their hospital. When the radioactivity is at a safe level she may resume breastfeeding. A method for measuring milk radioactivity and determining the time when a mother can safely resume breastfeeding has been published.[7]
Possible effects of Chromium Cr 51 Edetate on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Chromium Cr 51 Edetate
None listed
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Leide-Svegborn S, Ahlgren L, Johansson L et al. Excretion of radionuclides in human breast milk after nuclear medicine examinations. Biokinetic and dosimetric data and recommendations on breastfeeding interruption. Eur J Nucl Med Mol Imaging. 2016;43:808-21. PMID: 26732471
2. Mattsson S, Johansson L, Leide Svegborn S et al. Radiation dose to patients from radiopharmaceuticals: A compendium of current information related to frequently used substances. Annex D. Recommendations on breast-feeding interruptions. Ann ICRP. 2015;44 (2 Suppl):319-21. PMID: 26069086
3. Howe DB, Beardsley M, Bakhsh S. Appendix U. Model procedure for release of patients or human research subjects administered radioactive materials. In, NUREG-1556. Consolidated guidance about materials licenses. Program-specific guidance about medical use licenses. Final report. U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards. 2008;9, Rev. 2. http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/
4. Mountford PJ, Coakley AJ. A review of the secretion of radioactivity in human breast milk: data, quantitative analysis and recommendations. Nucl Med Commun. 1989;10:15-27. PMID: 2645546
5. International Atomic Energy Agency. Radiation Protection and Safety in Medical Uses of Ionizing Radiation, IAEA Safety Standards Series No. SSG-46, IAEA, Vienna. 2018. https://www.iaea.org/publications/11102/radiation-protection-and-safety-in-medical-uses-of-ionizing-radiation
6. National Radiation Protection Board (UK). Administration of radioactive substances advisory committee. Notes for guidance on the clinical administration of radiopharmaceuticals and use of sealed radioactive sources. 2019. https://assets.publishing.service.gov.uk/government/…/file/…/ARSAC_NfG_2019.pdf
7. Stabin MG, Breitz HB. Breast milk excretion of radiopharmaceuticals: mechanisms, findings, and radiation dosimetry. J Nucl Med. 2000;41:863-73. PMID: 10809203
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
