The Pharmacy and Poisons Board now says that a Chinese oral contraceptive pill which is harmful to Kenyan women is not authorised for use or distributions in the country.
“The product is substandard and falsified (SF) and poses a great risk to the health and safety of the public,” read part of the statement from the board.
PPB says it has initiated a rapid response and heightened surveillance to confirm and check whether the oral contraceptive ‘Sophia’ is in the Kenyan market.
“… with the aim of determine the source and implementing legal and regulatory actions against individuals who may be handling or distributing the product,”
The once-a-month pill, Sophia, was banned in Kenya 10 years ago, but has since made its way back into the market, touted as a natural herbal product with no side effects.
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.
However, samples collected and tested by the Ministry of Health showed that the product is toxic and has severe impact on the user.
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.
The banned drug is said to have side effects on breastfeeding mothers with the common ones being nausea, tender breasts, palpitations, ‘heavy’ legs and tiredness. Other complications associated with the drug are swollen feet, painful muscles and slurred speech.
Children born to women who have been on this pill present with early breast and uterus enlargement and develop to men faster for the males.
Babies who are breastfeeding are also exposed to the chemicals in the drug and carry the risk of developing secondary sexual features at a tender age.