Misanet.com / WOZA, 24 January - The "morning after pill" will be available over the counter in South Africa for the first time, which means no doctor's prescription is needed, from the end of January. Norlevo, launched by its distributor Medi Challenge in Sandton on Wednesday, will cost R60. The pill is almost 90% effective in preventing pregnancy for up to three days (down to 58% after 72 hours) after unprotected intercourse.
The move is welcomed by the Reproductive Rights Alliance, but RRA spokesperson Judy Merckel told iClinic that it will be some time still before this product is going to alleviate unwatned pregnancies among poor women in this country. "Women need to be taught about their bodies - basic education needs to happen first before this is going to make a difference, says Merckel," adding that R60 is still too expensive to working class women.
Emergency Contraception (EC) is the first undertaking of France-based Laboratoire HRA Pharma, and has led to the commercialisation of NorLevo® worldwide. Medi Challenge has been known for its involvement in immunotherapy - more in terms of allergies than HIV - as well as seawater micro-dispersion, a product that clears nasal passages.
Its third activity of note is female healthcare, where it has a wide variety of products in the pipeline - possibly including the abortion pill, although company representatives hinted, but would not confirm this - and aims to provide access to these products to women of all cultures, ages and everywhere in the world.
Medi Challenge had its first contact with the health ministry and the Medicines Control Council in 1995, the moment of registration, and says it has shown "patience and determination to get the product onto the SA market - it took 28 months for just a simple product such as this," Philippe Ratzel of Medi Challenge lamented, adding that in his home country, France, this process only took one month.
Norlevo was presented and explained by Professor Harry Seftel, independent spokesperson for the company and - he says - author of more than 300 papers in medical journals worldwide. Seftel pointed to some interesting findings from a 1998 UK Sex Survey, which
Causes of unprotected coitus are no contraceptives; condoms bad, broken or slipped; missed oral contraceptive pills or antibiotics; IUD not in place; diaphragm or cap moved or removed too early; failure of coitus interruptus or rhythm method; and rape.
Seftel points out that emergency contraception (EC) may be the solution to this problem, and mentioned some old and new methods of EC:
He explains that hormonal methods work by blocking ovulation, interfering with fertilisation and/or preventing implantation in the womb - he says the scientists are still not sure exactly how hormonal methods really work. The main thing to remember, says Seftel, is that they do NOT cause abortion.
South Africa will from the end of this month have access to two hormonal methods of emergency contraception:
Seftel explains that Yuzpe and Norlevo were compared in a randomised controlled trial in 1998, organised by the World Health Organisation and published in The Lancet. The result: Norlevo was more effective.
The trial focused on healthy women with regular menstruation, was done in 21 centres worldwide, and the women had had one act of unprotected coitus within 72 hours of the start of therapy. The women were divided into three groups: 0-24 hours after unprotected sex, 25-48 hours and 49-72 hours. In the first group (0-24 hours), Yuzpe prevented 77% of expected pregnancies, whereas Norlevo prevented 85%. This goes on in the second (25-48 hours) group, with Yuzpe 36% and Norlevo 85% and in the third group (49-72) - Yuzpe 31% and Norlevo 58%.
Norlevo was also better tolerated by the women in the studies: 23% reported nausea and 6% actual vomiting, versus 50% and 19% in the Yuzpe trials respectively. Seftel explains this is due to the oestrogen content of Yuzpe - Norlevo is oestrogen-free and has therefore also little or no risk of thrombosis, migraine or attacks of porphyria (a rare disease that can cause intermittent attacks of abdominal pain as well as a variety of other symptoms which range from mild to life-threatening).
- Because it is oestrogen-free and safe, Norlevo will be available in SA as an over-the-counter medicine from pharmacists ie the Medicines Control Council has classified it as a Schedule 2 drug, explains Seftel.
Seftel says the Yuzpe-type in South Africa has oestrogen, and the MCC therefore wants a doctor's prescription, to monitor whether the patient is at risk for thrombosis. Another advantage of Norlevo is that it has a relatively long shelf-life of 24 months, which makes it usable in rural areas.
All these advantages taken into account, both Seftel and Medi Challenge representatives have indicated that the health department welcomes the product and is keen to begin distributing it to state clinics throughout the country. Although invited, no health department representatives were present at the launch. "In practice, Norlevo should be taken as soon as possible after unprotected sex. If the woman has vomited, she should take another tablet immediately after.
- Women can take the tablet at any time in their cycle and at any age and should be advised that after taking Norlevo, they should refrain from having unprotected coitus again, and use standard contraception, which is more effective than EC, warns Seftel.
Norlevo should not be taken when pregnancy is suspected, with abnormal vaginal bleeding - which indicates the woman may already be pregnant - and if the patient is allergic to progesterone, povidome or silica.
If Norlevo was successful, a normal period occurs at more or less the normal time. Failure is indicated by a period delay of more than five days - the woman should then see a doctor and have a pregnancy test. "If she is pregnant, there is no increased risk to the foetus from taking Norlevo," emphasises Seftel.
He says that Norlevo-type products have a good worldwide track record, with years of experience (China has had the product for 15 years), with a large number of users both in developed and developing countries. "Over-the-counter provision of EC has been shown not to decrease regular contraception or to encourage repeat EC use," says Seftel.
Some of the misconceptions around EC: the term "morning-after pill" is a misnomer, because the pill is effective up to 72 hours - but EC is less effective and convenient than normal contraception.
Is this an abortion pill? No, says Seftel. "By definition, abortion removes an implanted, fertilised egg from the womb - the EC method does not allow the implant to take place." Medi Challenge spokesperson Philippe Ratzel later explained to iClinic that the well known RU-486 abortion pill can be used as EC, but there is not yet evidence enough to develop the product for that application.
By Marjolein Harvey, WOZA