A Chinese-made fertility pill that was banned from the Kenyan market 10 years ago due to multiple negative side effects on women and babies is being sold secretly in some parts of the country, the Business Daily has established.
The once-a-month pill popularly known as Sofia is being sold in herbal clinics behind the back of the sector’s regulator, the Kenya Pharmacy and Poisons Board (PPB).
The pill is easy to buy online and from ‘herbal clinics’ and also from unscrupulous dealers who deliver purchases on order across the country.
Their relative affordability, at about Sh200 per tablet, and the one-time-use per month, has made the pills attractive to women keen on family planning.
The illegal pills, sold under the guise that they are herbal to mean they are made from natural ingredients, have been reported to cause negative side-effects on women and children of breastfeeding mothers.
Women on the pill experience varying side effects with the most common ones being nausea, tender breasts, palpitations, "heavy" legs, tiredness and a feeling of false pregnancy.
A past analysis of 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 pills were found to have over 40 times the recommended levonorgestrel and quinestrol hormones.
The tests also indicated that some pills contained as much as 3000mcg of estradiol, 100 times more than the recommended dosage.
The recommended daily pill contains 30mcg. The results found varying amounts of the active ingredients with some pills being of no value.
"Excess estradiol which is an analogue of oestrogen poses a risk of blood clots and heart disease," said Dr Jill Mutua, a senior pharmacist.
"Babies born to these women or babies breastfeeding while their mothers are on the pills are exposed to excess oestrogen and carry a risk of developing secondary sexual features."
Cases of children born with enlarged breasts and abnormally developed uterus of children below three years have been recorded.
Other complications in breastfeeding children were swollen feet, knock-knees, painful muscles and slurred speech.
A user of the pill who spoke to the Business Daily said she missed her menses for months after discontinuing its usage and only visited a gynaecologist when she started developing health complications.
She had an abnormally thickened endometrium, which poses a high risk of endometrial cancer.
"Consumption is vast and some of the women I have attended to in the past suffered blood clots while others are now infertile; the effects vary," said Dr Njoki Fernandes, a gynaecologist and wellness consultant.
"There is no literature regarding this drug, and so when faced by a patient it is hard to know where to begin. All we know is that for a single dose to be effective for a whole month, then it must have high doses of the hormones and that is very dangerous to the health of the woman," said Dr Fernandes, also Chief Health Adviser at Minet Kenya.
It was not immediately clear how the pills still get through into the country, but it is believed that laxity by officers at the points of entry have fueled their proliferation.
Women falling prey to the dealers are also unable to verify the composition of the pill since information on the pack is in Chinese language, which is contrary to the Laws of Kenya, Cap 244.