The Sofia pill: Leaving fatalities and birth defects in its wake

On March 21, George Ssendagala lost his wife Barbra Atwine who collapsed at the police headquarters in Naguru, Kampala, while delivering food supplements.
Ssendagala claims his wife’s death could have been caused by an unprescribed pill she had been using. The pill, deemed to be harmful was banned by the National Drug Authority (NDA), in October last year. However, the ban might have even made the drug more popular. 
A woman who prefers anonymity says the pill commonly known as aka’ba China is used as a family planning method and she uses it because it is convenient (one tablet a month), affordable (costs Shs10,000) and ideal since other birth control methods caused her severe bleeding. 

READ: Woman dies after taking banned contraceptive pills
Dr Katali Ndozire, a gynaecologist at Mildmay Uganda, cautions against self-prescription and urges everyone to go to a health centre for professional guidance and counselling about contraception. 
He says, “Apart from safety issue, seeking professional help is key. In cases where one has issues with the prescription, they can return and report those challenges so that they get an alternative that suits them best.”
Factors
Dr Vincent Karuhanga, a general physician at Friends PolyClinic, for one to choose a contraceptive method, availability, cost, effectiveness and side effects should be put into consideration.
He says, “In a few circumstances, the frequency of dosage is considered, which is the main reason why many Ugandans are self-prescribing this once a month pill despite not being aware of its side effects or effectiveness since the labels are in the Chinese language.”
Experts reveal that apart from the pills having negative side effects on the mothers, they may cause breast and uterus enlargement to their babies. Breastfeeding children may develop swollen feet, knock knees and stunted speech.
Dr Karuhanga says mothers may report feeling pregnant all the time while others may go into depression apart from an increased risk of blood clots, bleeding, nausea, headaches, weight gain, and breast tenderness. 
"Since the contraceptives are sold in herbal clinics as herbal medicine, it is difficult to know all the chemicals in the pills in order to gauge whether they may have long-term effects or not or what they could be," he explains. 
The ban
In October 2022, NDA after research and surveillance issued a warning against the use of the Chinese contraceptive pill. NDA warned that whoever is selling or using it is doing so illegally because it contains high doses of hormones above the recommended dosage.
However, since the ban, more women seem to be using it by buying the pill on the black market.  According to Abiaz Rwamwiri, the NDA spokesperson, they are tracking down the source of supply which is highly concealed and syndicated. They are, however, optimistic that their intelligence and enforcement teams will crack them down.
The pill is said to be associated with prolonged bleeding, irregular menstrual periods, palpitations, the possibility of blood clots and heart disease. It can also lead to cancer in the uterine area and   cause infertility. It has led to several cases of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) where blood clots develop in the veins and are fatal.
In a public statement made by NDA, one of the concerns is that, “The Chinese pill tablet packaging, labelling and patient information leaflet is in Chinese language except for the claimed ingredients Levonorgestrel and Quinestrol. The NDA informs the public that the Chinese pill is not registered nor authorised for sale and use in Uganda.”
Ingredients 
The Chinese contraceptive pill is said to have high concentrations of synthetic progestogen (levonorgestrel) and long-acting estrogen (quinesterol) hormones that not only stop ovulation but persist in the body, sometimes causing infertility. If a woman conceives, the foetus is likely to be born with abnormal hormonal levels.
“Furthermore, when consumed, the hormones stay in the body for a long time and the adverse effect of the pill further manifests in babies that are born to the mothers. The adverse effects include secondary sexual characteristics such as premature puberty,” Dr Karuhanga says.
Elsewhere
By the time the pill was banned in Uganda, other countries had already taken the initiative.
In September 2016, health experts in Zambia warned that the side effects of the pill are difficult to treat because the exact contents of the pill are unknown. Apparently, the packaging information of the pill is in Mandarin Chinese and displays the name Hua Run Zi Zhu Pharmaceuticals Beijing.
Also in Kenya, the same pill had been banned in 2009 but in June 2019, the Business Daily reported a comeback of the Sofia pill (which is its street name) and was being sold by unscrupulous dealers who deliver purchases on order across the country and in herbal clinics behind the back of the sector’s regulator, the Kenya Pharmacy and Poisons Board (PPB).  
The analysis done on the pill at the National Quality Control Laboratory (NQCL) that led to the banning of the drug found it to have abnormally high levels of the hormones levonorgestrel and quinestrol, the active ingredients in conventional contraceptive pills.
The tests also indicated that some pills contained as much as 3000mcg of estradiol, 100 times more than the recommended dosage. According to the World Health Organisation (WHO), the recommended dosage of the estradiol in the daily pill should be 30mcg.
About birth control pills
There are several medically proven ways of preventing pregnancy and according to the World Health Organisation (WHO), birth control pills are a type of hormonal contraception that is 99 percent effective at preventing pregnancy when taken consistently every day.
Being consistent helps keep hormone levels from fluctuating so you do not have to forget to take the pill for even a day. The hormones in birth control pills prevent pregnancy by reducing ovulation, thinning the lining of the uterus so that a fertilised egg is less likely to attach or thickening cervical mucus to keep sperm from entering the uterus.
There are two different types of birth control pills and they both contain hormones that prevent pregnancy; the combination pills which contain estrogen and progestin and the progestin-only pills. The latter is better for breastfeeding women or those that have a history of blood clots and strokes. The combination birth control pill can decrease milk production since it contains estrogen. 
The pill comes in different dosing packets depending on the brand and a woman has to take at least three weeks of the active pills followed by seven days of hormone-free (inactive) pills. This is because most women have a menstrual period during the inactive pills.
Levonorgestrel, also known as the morning-after pill or emergency pill, is an oral emergency contraceptive pill approved by WHO to prevent pregnancy.

Emergency pills
Dr Joseph Nsangiyumva, a gynaecologist at Bethany Women’s Hospital in Luzira, remarks that the emergency pills are used after having unprotected sexual intercourse. They can be used by girls and women within the reproductive age (16-45 years).
The emergency contraceptive acts by preventing fertilisation by reducing the rate at which the sperms or ovum move within the uterus. This should be taken within 72 hours of unprotected sex or when a contraceptive failure has occurred because sperms can stay for three days while the ovum stays viable for two days while in the uterus before fertilisation takes place.
The commonest emergency pill in Uganda is the Postinor-2 tablet which may be in different quantities of 750(micro grammes) or 1.5 grammes and different pharmacies and drug shops sell them between Shs8, 000 and Shs10,000.
One 1.5g tablet should be taken as soon as possible or preferably within 12 hours and not later than 72 hours after sexual intercourse.
After taking the emergency contraceptive, it is recommended to use a barrier method such as condoms, diaphragm or cap during sex until the next menstrual period starts.
Dr Nsengiyumva adds that the pill does not substitute the normal family planning pills and a woman should continue with her contraceptive pills after two to three  days of taking the emergency pill(s).
While using injecta-plan as a birth control method, a woman should not take the emergency pills unless the time for the validity of the injection has expired or if she has delayed getting the next injection.
He adds that, “The pills are only for emergencies and are not recommended for daily use as regular family planning method.”
Ectopic pregnancy may occur if taken after 72 hours in case of a conception. This is because the pill slows down the movement of the zygote from the fallopian tube to the uterus after fertilisation.