Literature DB >> 22876106

Hydroxyprogesterone caproate injection (makena) one year later: to compound or not to compound that is the question.

Yesha Patel, Martha M Rumore.   

Abstract

Preterm births have increased by 27% over the last decade in the U.S. The main ingredient in Makena, 17P, is less expensive at compounding pharmacies, but this method is not FDA-approved. The authors discuss the quality, safety, and use of Makena and compounded 17P; the potential for liability; cost considerations; and recommended restrictions for the product's use.

Entities:  

Year:  2012        PMID: 22876106      PMCID: PMC3411212     

Source DB:  PubMed          Journal:  P T        ISSN: 1052-1372


  10 in total

1.  The drugs we deserve.

Authors:  Jim Thornton
Journal:  BJOG       Date:  2003-11       Impact factor: 6.531

Review 2.  Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data.

Authors:  Roberto Romero; Kypros Nicolaides; Agustin Conde-Agudelo; Ann Tabor; John M O'Brien; Elcin Cetingoz; Eduardo Da Fonseca; George W Creasy; Katharina Klein; Line Rode; Priya Soma-Pillay; Shalini Fusey; Cetin Cam; Zarko Alfirevic; Sonia S Hassan
Journal:  Am J Obstet Gynecol       Date:  2011-12-11       Impact factor: 8.661

3.  Progesterone and the risk of preterm birth among women with a short cervix.

Authors:  Eduardo B Fonseca; Ebru Celik; Mauro Parra; Mandeep Singh; Kypros H Nicolaides
Journal:  N Engl J Med       Date:  2007-08-02       Impact factor: 91.245

4.  ACOG Committee Opinion number 419 October 2008 (replaces no. 291, November 2003). Use of progesterone to reduce preterm birth.

Authors: 
Journal:  Obstet Gynecol       Date:  2008-10       Impact factor: 7.661

5.  Unintended consequences--the cost of preventing preterm births after FDA approval of a branded version of 17OHP.

Authors:  Joanne Armstrong
Journal:  N Engl J Med       Date:  2011-03-16       Impact factor: 91.245

6.  The risk for preterm labor in women receiving 17 alpha-hydroxyprogesterone caproate prophylaxis for preterm birth prevention.

Authors:  Saju Joy; Debbie J Rhea; Niki B Istwan; Cheryl N Desch; Gary Stanziano
Journal:  Am J Perinatol       Date:  2009-12-10       Impact factor: 1.862

7.  ACOG Committee Opinion. Use of progesterone to reduce preterm birth.

Authors: 
Journal:  Obstet Gynecol       Date:  2003-11       Impact factor: 7.661

8.  Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo.

Authors:  Allison T Northen; Gwendolyn S Norman; Kristine Anderson; Lisa Moseley; Michelle Divito; Margaret Cotroneo; Melissa Swain; Sabine Bousleiman; Francee Johnson; Karen Dorman; Cynthia Milluzzi; Jo-Ann Tillinghast; Marcia Kerr; Gail Mallett; Elizabeth Thom; Susan Pagliaro; Garland D Anderson
Journal:  Obstet Gynecol       Date:  2007-10       Impact factor: 7.661

9.  Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.

Authors:  Paul J Meis; Mark Klebanoff; Elizabeth Thom; Mitchell P Dombrowski; Baha Sibai; Atef H Moawad; Catherine Y Spong; John C Hauth; Menachem Miodovnik; Michael W Varner; Kenneth J Leveno; Steve N Caritis; Jay D Iams; Ronald J Wapner; Deborah Conway; Mary J O'Sullivan; Marshall Carpenter; Brian Mercer; Susan M Ramin; John M Thorp; Alan M Peaceman; Steven Gabbe
Journal:  N Engl J Med       Date:  2003-06-12       Impact factor: 91.245

10.  RETIRED: The use of progesterone for prevention of preterm birth.

Authors:  Dan Farine; William Robert Mundle; Jodie Dodd
Journal:  J Obstet Gynaecol Can       Date:  2008-01
  10 in total
  8 in total

1.  Inequality and Innovation: Barriers and Facilitators to 17P Administration to Prevent Preterm Birth among Medicaid Participants.

Authors:  Caitlin Cross-Barnet; Sarah Benatar; Brigette Courtot; Ian Hill; Emily Johnston; Morgan Cheeks
Journal:  Matern Child Health J       Date:  2018-11

Review 2.  U.S. Compounding Pharmacy-Related Outbreaks, 2001-2013: Public Health and Patient Safety Lessons Learned.

Authors:  Nadine Shehab; Megan N Brown; Alexander J Kallen; Joseph F Perz
Journal:  J Patient Saf       Date:  2018-09       Impact factor: 2.844

3.  Makena or Compounded 17P?

Authors:  James P Reichmann
Journal:  P T       Date:  2012-09

4.  Propensity score matching for treatment delay effects with observational survival data.

Authors:  Erinn M Hade; Giovanni Nattino; Heather A Frey; Bo Lu
Journal:  Stat Methods Med Res       Date:  2019-10-01       Impact factor: 3.021

5.  Use and attitudes of obstetricians toward 3 high-risk interventions in MFMU Network hospitals.

Authors:  Sabine Zoghbi Bousleiman; Madeline Murguia Rice; Joan Moss; Allison Todd; Monica Rincon; Gail Mallett; Cynthia Milluzzi; Donna Allard; Karen Dorman; Felecia Ortiz; Francee Johnson; Peggy Reed; Susan Tolivaisa
Journal:  Am J Obstet Gynecol       Date:  2015-05-06       Impact factor: 8.661

6.  The association between 17-hydroxyprogesterone caproate use and postpartum hemorrhage.

Authors:  Emily S Miller; Allie Sakowicz; Archana Roy; Lilly Y Liu; Lynn M Yee
Journal:  Am J Obstet Gynecol MFM       Date:  2019-04-28

7.  Evaluating progestogens for prevention of preterm birth international collaborative (EPPPIC) individual participant data (IPD) meta-analysis: protocol.

Authors:  Lesley A Stewart; Mark Simmonds; Lelia Duley; Kristina Charlotte Dietz; Melissa Harden; Alex Hodkinson; Alexis Llewellyn; Sahar Sharif; Ruth Walker; Kath Wright
Journal:  Syst Rev       Date:  2017-11-28

Review 8.  Potential risks of pharmacy compounding.

Authors:  Jennifer Gudeman; Michael Jozwiakowski; John Chollet; Michael Randell
Journal:  Drugs R D       Date:  2013-03
  8 in total

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