1,971
Views
14
CrossRef citations to date
0
Altmetric
Research Article

Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

&
Pages 540-549 | Received 20 Dec 2011, Accepted 24 Jan 2012, Published online: 13 Feb 2012

References

  • Ward RM, Beachy JC. (2004). Neonatal Complications Following Preterm Birth. Int J Obstet Gynecol, 110:8–16.
  • Iams JD, Berghella V. (2010). Care for women with prior preterm birth. Am J Obstet Gynecol, 203:89–100.
  • Tita AT, Rouse DJ. (2009). Progesterone for preterm birth prevention: an evolving intervention. Am J Obstet Gynecol, 200:219–224.
  • Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AHet al.; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. (2003). Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med, 348:2379–2385.
  • American College of Obstetricians and Gynecologists. (2008). Use of Progesterone to Reduce Preterm Birth. ACOG Committee Opinion No. 419. Obstet Gynecol, 112:963–965.
  • Meis PJ, Wing D, Powers B, Hickok D. (2010) U.S. Food and Drug Administration Drug Approval. Slow Advances in Obstetric Care in the United States Obstet Gynecol, 115:825–833.
  • Meis PJ, Reifenstein E. (1971) Hydroxyprogesterone Caproate Therapy in Advanced Endometrial Cancer Cancer, 27:485–502.
  • United State Pharmacopeia 34 – National Formulary 29. The United States Pharmacopeial Convention, Rockville, MD. 2011.
  • U.S. Food and Drug Administration. The Special Risks of Pharmacy Compounding. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm Accessed on 15 April 2011.
  • Sasich LD, Sukkari SR. (2008). Unknown risks of pharmacy-compounded drugs. J Am Osteopath Assoc, 108:86.
  • American College of Obstetricians and Gynecologists. Pharmaceutical Compounding. (2007). ACOG Committee Opinion No. 387. Obstet Gynecol, 110:1213–1214.
  • US Food and Drug Administration. Pharmacy Compounding. 2006 Limited FDA Survey of Compounded Drug Products. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm204237.htm. Accessed on 15 April 2011.
  • Missouri Board of Pharmacy Compounding Report. FY2006–2009. Accessed at: http://pr.mo.gov/pharmacists - compounding.asp. Accessed April 2011.
  • Markman BE, Rosa PC, Koschtschak MR. (2010). Assessment of the quality of simvastatin capsules from compounding pharmacies. Rev Saude Publica, 44:1055–1062.
  • Green DM, Jones AC, Brain KR. (2011). Content variability of active drug substance in compounded oral 3,4-diaminopyridine products. J Clin Pharm Ther, 1–6.
  • Azarnoff DL, Lee JC, Lee C, Chandler J, Karlin D. (2007). Quality of extemporaneously compounded nitroglycerin ointment. Dis Colon Rectum, 50:509–516.
  • Mahaguna V, McDermott JM, Zhang F, Ochoa F. (2004). Investigation of product quality between extemporaneously compounded progesterone vaginal suppositories and an approved progesterone vaginal gel. Drug Dev Ind Pharm, 30:1069–1078.
  • Sunenshine R, Schultz M, Lawrence MG, Shin S, Jensen B, Zubairi Set al. (2009). An outbreak of postoperative gram-negative bacterial endophthalmitis associated with contaminated trypan blue ophthalmic solution. Clin Infect Dis, 48:1580–1583.
  • Suchard JR, Graeme KA. (2002). Pediatric clonidine poisoning as a result of pharmacy compounding error. Pediatr Emerg Care, 18:295–296.
  • Centers for Disease Control. (2007). Deaths from Intravenous Colchicine Resulting from a Compounding Pharmacy Error – Oregon and Washington, 2007. MMRW Morbid Mortal Wkly, 56:1050–1052.
  • Gershman MD, Kennedy DJ, Noble-Wang J, Kim C, Gullion J, Kacica Met al.; Pseudomonas fluorescens Investigation Team. (2008). Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy. Clin Infect Dis, 47:1372–1379.
  • Schwam E. (2011). Severe accidental overdose of 4-aminopyridine due to a compounding pharmacy error. J Emerg Med, 41:51–54.
  • Cohen AW, Copel JA, Macones GA, Menard MK, Riley L, Saade GR. (2011). Unjustified increase in cost of care resulting from U.S. Food and Drug Administration approval of Makena (17a-hydroxyprogesterone caproate). Obstet Gynecol, 117:1–3.
  • Bradshaw ST, Sampson K, Wesoloski BJ. (2011). The Food and Drug Law Institute. Did FDA Apply a Remedy Worse Than the Disease in Refusing to Clear the Market of Unapproved Versions of Makena? Food and Drug Policy Forum, 1:1–8.
  • Food and Drug Administration. FDA Statement on Makena. Available at: http://www.fda.gov/newsEvents/Newsroom/Press Announcements/ucm249025.htm. Accessed on 12 December 2011.
  • Food and Drug Administration. Impurities in New Drug Substances. June 2008, (International Committee on Harmonization, Revision 2).
  • Onsrud M, Paus E, Haug E, Kjørstad K. (1985). Intramuscular administration of hydroxyprogesterone caproate in patients with endometrial carcinoma. Pharmacokinetics and effects on adrenal function. Acta Obstet Gynecol Scand, 64:519–523.
  • Liu H, Zhang Z, Linhardt RJ. (2009). Lessons learned from the contamination of heparin. Nat Prod Rep, 26:313–321.
  • Guan N, Fan Q, Ding J, Zhao Y, Lu J, Ai Yet al.. (2009). Melamine-contaminated powdered formula and urolithiasis in young children. N Engl J Med, 360:1067–1074.
  • Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 6th edition. Philadelphia: Lippincott Williams and Wilkins, 2002:xv–xix.
  • Kaye T. (2003). The quandary of compounding for MCOs: administrative costs, risks, and waste. Manag Care, 12:42–48.
  • Boodoo JM. Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDMA Circuit Split. Am J Law Med, 2010:220:1–27.
  • ACOG and SMFM update position on 17P. Contemp Obgyn 2011; December 2011:13.
  • FDA Statement on Makena. US Food and Drug Administration, Silver Spring, MD. November 8, 2011.