Primodos

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Primodos
Medical diagnostics
PurposeDetermine if pregnancy is present

Primodos was a hormone-based pregnancy test used in the 1960s and 1970s that consisted of two pills that contained norethisterone (as acetate) and ethinylestradiol.[1][2] It detected pregnancy by inducing menstruation in women who were not pregnant. The presence or absence of menstrual bleeding was then used to determine whether the user was pregnant.[1] It was suggested to be used in South Korea "perhaps as a double dose" with a completely different purpose - to abort the foetus [3]

First made available for sale in the UK in 1959, it was withdrawn from sale in the UK in 1978.[4]

Primodos was produced by Schering AG, a German company taken over by Bayer AG in 2006.

Another hormonal pregnancy test called Duogynon was in use in Germany during the same general time period.[1]

History[edit]

In the 1960s, Dr. Isabel Gal did research at Queen Mary's Hospital for Children that showed a link between use of the drug and severe birth defects.[5] A review by the Committee on Safety of Medicines in the 1970s concluded that the product should not be used by pregnant women.[2] Litigation in the 1980s regarding these claims ended inconclusively, with proceedings being discontinued, with the court's approval.[1][6] A review of the matter by the Medicines and Healthcare Products Regulatory Agency in 2014 assessed the studies performed to date, and concluded that it found the evidence for adverse effects to be inconclusive.[1][7]

The report of an expert working group of the UK Commission on Human Medicines published in November 2017 concluded there was no “causal association” between Primodos and severe disabilities in babies. The expert group recommended that families who took a hormone pregnancy test and experienced “an adverse pregnancy outcome” should be offered genetic testing to establish whether there was a different underlying cause.[8]

References[edit]

  1. ^ a b c d e Sarah Rainey (12 May 2014). "'Is this the forgotten thalidomide?'". Daily Telegraph.
  2. ^ a b Department of Health, Hansard, HL Deb, 26 October 2010, c264W [1]
  3. ^ "UK pregnancy test drug Primodos used for abortions in Germany".
  4. ^ "Hormone pregnancy tests". Medicines and Healthcare Products Regulatory Agency. Retrieved 12 May 2014.
  5. ^ Montuschi, Mike (2018-03-13). "Isabel Gal obituary". the Guardian. Retrieved 2018-06-21.
  6. ^ "Jury still out in pregnancy test case", New Scientist, 8 July 1982, page 79
  7. ^ "Assessment of historical evidence on Primodos and congenital malformations – a synopsis" (PDF). Medicines and Healthcare Products Regulatory Agency. 2014. Retrieved 12 May 2014.
  8. ^ "Report of the Commission on Human Medicines Expert Working Group on Horrmone Pregnancy Tests" (PDF). UK Government Web site. 15 November 2017. Retrieved 15 November 2017.