Medright Consulting

Posted By Dennis Kithinji

The Banned Contraceptive Pill: Is “Sophia” Safe?  

To mark World Contraception Day 2022, MedRight Consulting has chosen to contribute to the theme by discussing the medical-scientific details of “Sophia.” The day will be on Monday, September 26. Its theme is “Breaking Myths and Misconceptions on Family Planning.”

MedRight Consulting has reviewed the available literature to establish the real identity of “Sophia” and describe its serious adverse events. Sophia is a Kenyan nickname for a once-a-month oral contraceptive from China. Its high demand is contributing to its persistence in the Kenyan market despite a 2009 ban by the ministry of health. The high demand could be due to Sophia’s high efficacy in preventing pregnancy. The convenience of a monthly oral dose and affordability could also be fueling the demand. According to media reports, the monthly pill only costs Sh. 150-250.  

Although media communications regarding Sophia do not give its scientific identity, MedRight Consulting has established that the description provided in media points to Quin-Lng. Quin-Lng is a once-a-month oral contraceptive used in China. Perhaps that’s why the contraband Sophia is masked as Chinese herbal medicine.

Fact 1: Sophia is NOT Chinese herbal medicine

Quin-Lng is a combination of synthetic forms of estrogen and progesterone, just like several conventional contraceptives. To brief you, contraceptives work by disrupting the levels of reproductive hormones (primarily estrogen and progesterone) in the female reproductive cycle to prevent pregnancy in the presence of sperm. The estrogen component in Quin-Lng is quinestrol. The progesterone component is levonorgestrel.

The Chinese market has other variations of the once-a-month contraceptive pill. They also contain quinestrol as an estrogen source. Other synthetic compounds including norgestrel, formchlormadinone, or methylene chlormadinone serve as their progesterone sources. Having synthetic constituents means the once-a-month Chinese contraceptive pill is not herbal.  

Quin-Lng specifically comprises 3 mg of quinestrol and 6 mg of levonorgestrel. Another similar pill, Quin-Ng, comprises 3 mg of quinestrol and 12 mg of norgestrel. The National Quality Control Laboratory in Kenya analyzed Sophia and determined that it contains high levels of quinestrol and levonorgestrel. Therefore, Sophia’s contents match with Quin-Lng’s.   

Fact 2: Sophia is NOT Safe

One of the main serious adverse events associated with all oral contraceptives containing estrogen is venous thromboembolism (VTE). The risk of VTE increases with the increase in estrogen levels in a contraceptive. Pulmonary embolism (clot) is becoming a common term in the discussions of causes of death among women. Some cases go undetected since deaths happen before diagnosis and post-mortems are rarely conducted. Some related deaths are only reported as “she collapsed and died instantly.” My hypothesis is that contraceptives such as Sophia may be contributing to some incidences of the “she just collapsed” deaths.   

The high risk of serious adverse events lies in the levels of constituents in the once-a-month pill. Quinesterol is metabolized to release ethinyl estradiol, the compound in the daily oral contraceptives. Ethinyl estradiol is a replica of natural estrogen — the hormone whose levels peak a day before ovulation (by the way estrogen contributes to the high sex drive experienced by women around ovulation time).

Quinesterol is stored in the adipose tissue from where it is slowly released for metabolism to release ethinyl estradiol. The slow-release aspect is behind the drug’s ability to disrupt estrogen levels throughout the month.

The recommended dose of ethinyl estradiol in daily oral pills is less than 30 µg. The 3 mg of quinesterol releases about five times the recommended ethinyl estradiol (<30 µg) in combined contraceptive pills.

Therefore, women who take Sophia have abnormally high estrogen levels. High estrogen levels are associated with a high risk of venous thromboembolism (VTE), high blood pressure, and endometrial hyperplasia.

Additionally, women who use the once-a-month pill in China are advised not to be pregnant during the first year after stopping the oral contraceptive. Women who become pregnant within a year of stopping the once-a-month pill risk getting infants with malformations.

Fact 3: Quin-Lng is Approved for Use in Public Clinics in China

In 2002, Su-Wen Ma of the National Contraceptive Supply in Beijing indicated that a pill containing 3 mg of quinestrol and 6 mg of levonorgestrel was approved for used in China since 1998. The composition is consistent with the ingredients of Quin-Lng.

Notably, a review of evidence regarding the safety of the once-a-month pill was conducted under the patronage of National Population and Family Planning Commission of China. It was part of an assessment of family planning services in Chongqing Municipality, China. Although the review did not directly find the monthly pill as causative of VTE, it found higher than usual cases of hypertension, endometrial hyperplasia, and infant malformations among users of the pill.  

What are the Serious Adverse Events of Levonorgestrel?

Levonorgestrel is a synthetic progesterone in the Quin-Lng. It is also the chemical in the morning-after pill (P2). Besides, it is present in combination with estrogen replicas in implants and transdermal patches. We will discuss its adverse health effects in another article.

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References

Kejuan, F., Meirik, O., Yongang, D., Yan, C., Weijin, Z., & Fajans, P. (2007). Once-a-month contraceptive pills in China: a review of available evidence. Contraception75(5), 337-343. https://doi.org/10.1016/J.CONTRACEPTION.2007.01.007

Oketch, A. (2022). Stop popping banned Chinese contraceptive pill, ministry warns. https://nation.africa/kenya/news/gender/stop-popping-banned-chinese-contraceptive-pill-ministry-warns-3959026

Gialeraki, A., Valsami, S., Pittaras, T., Panayiotakopoulos, G., & Politou, M. (2018). Oral contraceptives and HRT risk of thrombosis. Clinical and Applied Thrombosis/Hemostasis24(2), 217-225. https://journals.sagepub.com/doi/pdf/10.1177/1076029616683802

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