Primodos: Difference between revisions
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There are disputed claims as to whether Primodos may have been the cause of [[birth defect]]s.<ref>{{cite web|url=http://news.sky.com/story/848419/fresh-forgotten-thalidomide-legal-claim|title=Fresh 'Forgotten Thalidomide' Legal Claim|publisher=Sky News|date=11 April 2011}}</ref> A review by the [[Committee on Safety of Medicines]] in the 1970s concluded that the product should not be used by pregnant women.<ref name=hansardc264W/> Litigation in the 1980s regarding these claims ended inconclusively, with proceedings being discontinued, with the court's approval.<ref>"Jury still out in pregnancy test case", ''New Scientist'', 8 July 1982, page 79</ref><ref name=Rainey2014/> 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.<ref name=MHRAreview2014>{{cite web|url=http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con404471.pdf|title= |
There are disputed claims as to whether Primodos may have been the cause of [[birth defect]]s.<ref>{{cite web|url=http://news.sky.com/story/848419/fresh-forgotten-thalidomide-legal-claim|title=Fresh 'Forgotten Thalidomide' Legal Claim|publisher=Sky News|date=11 April 2011}}</ref> A review by the [[Committee on Safety of Medicines]] in the 1970s concluded that the product should not be used by pregnant women.<ref name=hansardc264W/> Litigation in the 1980s regarding these claims ended inconclusively, with proceedings being discontinued, with the court's approval.<ref>"Jury still out in pregnancy test case", ''New Scientist'', 8 July 1982, page 79</ref><ref name=Rainey2014/> 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.<ref name=MHRAreview2014>{{cite web|url=http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con404471.pdf|title= |
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Assessment of historical evidence on Primodos and congenital malformations – a synopsis|publisher=Medicines and Healthcare Products Regulatory Agency|date=2014|accessdate=12 May 2014}}</ref><ref name=Rainey2014/> |
Assessment of historical evidence on Primodos and congenital malformations – a synopsis|publisher=Medicines and Healthcare Products Regulatory Agency|date=2014|accessdate=12 May 2014}}</ref><ref name=Rainey2014/> |
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A UK-based documentary on Sky News HD, aired at 8{{nbsp}}pm on 16 April 2017, exposes several previously undisclosed facts linking the manufacturer of Primodos to several cover-ups together with UK regulators and expert consultant physicians. The documentary demonstrates factually that the drug had not been tested for toxicology and teratogenicity before introduced into the UK and German markets. In the USA, Squib, who produced a similar hormonal pregnancy testing drug (Gestest), paid out a significant award to the family for a boy born without any limbs in exchange for a gag order. |
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The report of an expert working group of the [[Commission on Human Medicines|UK Commission on Human Medicines]] published in November 2017 concluded there was no “causal association” between Primodos and severe disabilities in babies. Despite those conclusions, campaigners still believe that as well as causing disabilities, the drugs could also cause miscarriage or stillbirth. 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.<ref>{{Cite web|url=https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/659115/Report-CHM-EWG-HPTs_FINAL.pdf|title=Report of the Commission on Human Medicines Expert Working Group on Horrmone Pregnancy Tests|last=|first=|date=15 November 2017|website=UK Government Web site|archive-url=|archive-date=|dead-url=|access-date=15 November 2017}}</ref> |
The report of an expert working group of the [[Commission on Human Medicines|UK Commission on Human Medicines]] published in November 2017 concluded there was no “causal association” between Primodos and severe disabilities in babies. Despite those conclusions, campaigners still believe that as well as causing disabilities, the drugs could also cause miscarriage or stillbirth. 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.<ref>{{Cite web|url=https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/659115/Report-CHM-EWG-HPTs_FINAL.pdf|title=Report of the Commission on Human Medicines Expert Working Group on Horrmone Pregnancy Tests|last=|first=|date=15 November 2017|website=UK Government Web site|archive-url=|archive-date=|dead-url=|access-date=15 November 2017}}</ref> |
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Revision as of 03:47, 17 November 2017
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]
First made available for sale in the UK in 1959, it was withdrawn from sale in the UK in 1978.[3]
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]
Claims of adverse effects
There are disputed claims as to whether Primodos may have been the cause of birth defects.[4] 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.[5][1] 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.[6][1] A UK-based documentary on Sky News HD, aired at 8 pm on 16 April 2017, exposes several previously undisclosed facts linking the manufacturer of Primodos to several cover-ups together with UK regulators and expert consultant physicians. The documentary demonstrates factually that the drug had not been tested for toxicology and teratogenicity before introduced into the UK and German markets. In the USA, Squib, who produced a similar hormonal pregnancy testing drug (Gestest), paid out a significant award to the family for a boy born without any limbs in exchange for a gag order.
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. Despite those conclusions, campaigners still believe that as well as causing disabilities, the drugs could also cause miscarriage or stillbirth. 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.[7]
References
- ^ a b c d e Sarah Rainey (12 May 2014). "'Is this the forgotten thalidomide?'". Daily Telegraph.
- ^ a b Department of Health, Hansard, HL Deb, 26 October 2010, c264W [1]
- ^ "Hormone pregnancy tests". Medicines and Healthcare Products Regulatory Agency. Retrieved 12 May 2014.
- ^ "Fresh 'Forgotten Thalidomide' Legal Claim". Sky News. 11 April 2011.
- ^ "Jury still out in pregnancy test case", New Scientist, 8 July 1982, page 79
- ^ "Assessment of historical evidence on Primodos and congenital malformations – a synopsis" (PDF). Medicines and Healthcare Products Regulatory Agency. 2014. Retrieved 12 May 2014.
- ^ "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.
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