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By GATONYE GATHURA
KENYA: Concerns over whether some popular emergency contraceptives or “morning after” pills prevent pregnancies in heavier women are behind demands for the placement of new labelling by the beginning of 2014.
Three weeks ago, European health regulatory authorities ordered Norlevo, the manufacturers of one such product — the most popular in the region — to place a warning indicating the pills do not prevent pregnancy in women weighing 75kg and more.
Following this development, health regulatory authorities in the US, Canada and Australia are reported to be reviewing available scientific information with the intention of taking remedial measures if necessary. The concerns followed findings by the University of Edinburgh, UK, indicating that the main chemical ingredient in their emergency pill, Norlevo, does not work well in heavier women.
The chemical in question, levonorgestrel, is also found in most of the morning after pills distributed in Kenya.
Such brands distributed locally include Postnor 2, Pregnon (also called Smart Lady), Truston and Ecee2. Another popular brand in the local market is Microgynon, which combines levonorgestral with another compound.
Norlevo will be relabeled from next month, with a warning that the drug’s efficacy is reduced in women who weigh more than 75kg and it is ineffective in those who weigh more than 80kgs.
Safe evidence
The British Medical Journal’s Global Weight Index indicates the average weight of the Kenyan woman to be 56kg.
However, many sexually active women, especially in urban Kenya, have been found to carry a lot of weight with more than 30 per cent in Nairobi being obese or overweight.
Family planning experts in Nairobi are now telling Kenyan women, even those weighing over 75kg, not to worry because history shows that these products have no weight limitation. According to Dr Marsden Solomon, a reproductive health expert at Family Health International (FHI 360) in Nairobi, these products are safe for use in all weight categories.
“There is a long-standing body showing that these pills are safe evidence and effective even for overweight and obese women,” Dr Solomon told The Standard on Sunday.
Email enquiries, text messages and even phone calls to the head of the Family Health Division at the Ministry of Health went unanswered.
Chemical composition
But even as Kenya takes “an all is fine” attitude, the US Federal Drug Agency said it would review all available data and scientific information on emergency contraceptives containing this chemical marketed in the country.
The most popular morning after pill in the US is called Plan B, with similar chemical composition with Norlevo and others distributed in Kenya.
This, the FDA said in an email to the US media, will inform what, if any, labelling changes will be warranted on emergency contraceptives in the US market.
Last Friday, the Therapeutic Goods Administration, the pharmaceutical regulatory authority in Australia was reported to be considering whether any action is required in the country.
Dr Solomon’s position and consequently that of FHI 360, seems to be highly influenced by a statement released by the developers of one of the products, Postinor, which is widely distributed in Kenya.
Just days after the European action on November 28, the manufacturers of Postinor – Gedeon Richter Ltd of Belgium claiming levonorgestrel-containing pills are safe and effective even for heavy, overweight and even obese women.
“Gedeon Richter levonorgestrel containing products have been on the market for more than 30 years and this is the very first time any possible association has arisen over weight limitations,” says the statement.
Safe and appropriate
Gedeon Richter further says it is their opinion that the administration of its emergency contraceptive products containing this chemical in overweight and obese women is safe and effective.
“Our advice at the moment is that the current National Family Planning Guidelines should remain unchanged,” says Dr Solomon.
Prepared for health workers by the Ministry of Health in 2009, the National Family Planning Guidelines for Service Providers says emergency contraceptives are safe and appropriate for all women.
It says those pills containing the compound in question prevents up to 95 per cent of expected pregnancies and gives Postinor 2, Pregnon, Smart lady, ECee2, and Truston2 as the most common in the local market.
A consumer, the guide says, should use one of the levonorgestral-containing pills as soon as possible after unprotected sex, but within 120 hours. This should be repeated on the same dosage after 12 hours.
Alternatively, two levonorgestrel-containing pills should be taken as a single dose as soon as possible after unprotected sex, but within 120 hours.
A study published last year by the Kenya Medical Research Institute and the Jomo Kenyatta University of Agriculture and Technology says about a quarter of sexually active women in Kenya are using emergency contraceptives. Available data indicates that between 2005 and 2010 the UNFPA had donated approximately 1.1 million units of ECs to the government while in 2009, the ministry of Health purchased about six million units.
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