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'''Primodos''' was a [[hormonal pregnancy test]] used in the 1950s to the 1970s, primarily in the [[United Kingdom]] and [[Germany]]. It consisted of two pills containing high doses of the hormones [[noretisterone]] and [[ethinylestradiol]]. Women who suspected they might be pregnant were instructed to take the pills and observe if a withdrawal bleed occurred, which was supposed to indicate the absence of pregnancy. However, the safety of Primodos came under scrutiny due to reports linking its use to a variety of [[birth defects]] in children born to mothers who had taken the test.
{{Short description|Hormonal pregnancy test}}
{{Use dmy dates|date=October 2023}}


==History==
'''Primodos''' was a hormonal pregnancy test used in the 1960s and 1970s. It was manufactured by the German pharmaceutical company Schering AG, which is now part of Bayer. The test was withdrawn from the market in the late 1970s due to concerns about its safety and potential links to birth defects.
Primodos was introduced in the 1950s as a convenient method for women to determine pregnancy. At the time, the mechanisms of [[hormonal regulation]] in pregnancy were not fully understood, and the potential risks associated with high doses of hormones were underestimated. Primodos became widely used in several countries before concerns about its safety began to emerge.


==Controversy and Health Concerns==
==Composition and Mechanism==
In the late 1960s and early 1970s, medical researchers started to report an association between the use of hormonal pregnancy tests like Primodos and an increased risk of birth defects, including [[limb deformities]], [[heart defects]], and [[spina bifida]]. These findings led to public and professional debate about the safety of such tests.
Primodos was composed of two hormones: [[Norethisterone]] and [[Ethinylestradiol]]. These are synthetic versions of the natural hormones progesterone and estrogen, respectively.


Despite the growing evidence and campaigns by affected families, the manufacturers and regulatory bodies were slow to react. It was not until 1978 that Primodos was withdrawn from the market in the UK. The delay in taking action has been a source of ongoing controversy and has led to accusations of a failure to protect public health.
[[File:Norethisterone.svg|Norethisterone|thumb|right]]
[[File:Ethinylestradiol.svg|Ethinylestradiol|thumb|left]]


==Legal and Parliamentary Inquiry==
The test worked by inducing a withdrawal bleed in women who were not pregnant. If the woman was pregnant, the hormonal changes induced by the test would not result in bleeding, thus indicating a positive pregnancy result.
The controversy surrounding Primodos has led to legal actions and a [[Parliamentary inquiry]] in the UK. Families affected by the use of Primodos have sought compensation and recognition of the harm caused. In 2017, the UK government ordered an independent review to investigate the decisions made by regulatory bodies regarding the safety of Primodos.
 
==Usage==
Primodos was administered in the form of two pills taken over two days. It was marketed as a convenient and quick method to determine pregnancy, at a time when other methods were less accessible or more time-consuming.
 
==Controversy and Withdrawal==
Concerns about the safety of Primodos began to emerge in the early 1970s. Studies suggested a potential link between the use of Primodos and congenital malformations in children born to mothers who had taken the test. These concerns led to increased scrutiny and eventually to the withdrawal of the product from the market.
 
In 1975, the Committee on Safety of Medicines in the UK issued a warning about the potential risks associated with hormonal pregnancy tests like Primodos. By 1978, the product was withdrawn from the market in the UK and other countries.
 
==Legal and Scientific Investigations==
Since its withdrawal, there have been numerous investigations and legal actions regarding the safety of Primodos. Families affected by birth defects have sought compensation, and various studies have been conducted to determine the extent of the risks associated with the test.
 
In recent years, there have been calls for further investigation into the historical handling of Primodos and the regulatory decisions made at the time. Some studies have suggested a possible association between the use of Primodos and birth defects, while others have found no conclusive evidence.


==Current Status==
==Current Status==
As of now, the debate over Primodos and its effects continues. The independent review and subsequent reports have highlighted failures in the regulatory response and have called for further research into the effects of hormone pregnancy tests. However, the pharmaceutical company involved and some regulatory authorities have contested the findings, leading to ongoing legal and scientific debates.
Primodos is no longer available on the market, and modern pregnancy tests have replaced hormonal methods with more accurate and safer alternatives, such as urine-based tests that detect the presence of human chorionic gonadotropin (hCG).


==See Also==
==Related pages==
* [[Thalidomide]]
* [[Norethisterone]]
* [[Drug regulation]]
* [[Ethinylestradiol]]
* [[Pharmacovigilance]]
* [[Pregnancy test]]
* [[Birth defect]]
* [[Pharmaceutical industry]]


[[Category:Pharmacology]]
[[Category:Pharmaceuticals]]
[[Category:Medical controversies]]
[[Category:Pregnancy tests]]
{{pharmacology-stub}}
[[Category:Withdrawn drugs]]

Latest revision as of 18:57, 23 March 2025

Hormonal pregnancy test



Primodos was a hormonal pregnancy test used in the 1960s and 1970s. It was manufactured by the German pharmaceutical company Schering AG, which is now part of Bayer. The test was withdrawn from the market in the late 1970s due to concerns about its safety and potential links to birth defects.

Composition and Mechanism[edit]

Primodos was composed of two hormones: Norethisterone and Ethinylestradiol. These are synthetic versions of the natural hormones progesterone and estrogen, respectively.

Norethisterone
Ethinylestradiol

The test worked by inducing a withdrawal bleed in women who were not pregnant. If the woman was pregnant, the hormonal changes induced by the test would not result in bleeding, thus indicating a positive pregnancy result.

Usage[edit]

Primodos was administered in the form of two pills taken over two days. It was marketed as a convenient and quick method to determine pregnancy, at a time when other methods were less accessible or more time-consuming.

Controversy and Withdrawal[edit]

Concerns about the safety of Primodos began to emerge in the early 1970s. Studies suggested a potential link between the use of Primodos and congenital malformations in children born to mothers who had taken the test. These concerns led to increased scrutiny and eventually to the withdrawal of the product from the market.

In 1975, the Committee on Safety of Medicines in the UK issued a warning about the potential risks associated with hormonal pregnancy tests like Primodos. By 1978, the product was withdrawn from the market in the UK and other countries.

Legal and Scientific Investigations[edit]

Since its withdrawal, there have been numerous investigations and legal actions regarding the safety of Primodos. Families affected by birth defects have sought compensation, and various studies have been conducted to determine the extent of the risks associated with the test.

In recent years, there have been calls for further investigation into the historical handling of Primodos and the regulatory decisions made at the time. Some studies have suggested a possible association between the use of Primodos and birth defects, while others have found no conclusive evidence.

Current Status[edit]

Primodos is no longer available on the market, and modern pregnancy tests have replaced hormonal methods with more accurate and safer alternatives, such as urine-based tests that detect the presence of human chorionic gonadotropin (hCG).

Related pages[edit]