Primodos
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 The test was withdrawn from the market in the late 1970s due to concerns about its safety and potential links to birth defects.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
Primodos was composed of two hormones: Norethisterone and Ethinylestradiol. These are synthetic versions of the natural hormones progesterone and estrogen, respectively.
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
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 By 1978, the product was withdrawn from the market in the UK and other countries.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
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).
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Contributors: Prab R. Tumpati, MD