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Are emergency contraceptive pills a necessary evil?
Increased use of emergency contraceptive pills has become
the talk of the town. But is it really safe to pop in one like a routine pill?
Suja Nair explores... (Extracted from Express Pharma, 16-31 April 2008)
 The
concept of an emergency contraception pill is known since long, and has been
practised from time immemorial. In ancient times, women used to douche themselves
with potion, liquid and eat different types of food so as to abort a potential
pregnancy. Present day women have modern ways of preventing pregnancy such as
birth pills, emergency pills etc. What is currently known as an emergency contraceptive
has been labelled as a morning after pill, postcoital pill, or contraceptive.
Of late, there has been debate on the safety issues concerning 'morning after'
pills, arising due to the unsupervised overuse of these pills. Dr Chandra M
Gulhati, Editor, MIMS, feels that since some of these pills contain high-dose
levonorgestral they should be used only in emergency situations (such as sex
under force) and certainly not as a substitute for conventional, much safer
methods like condoms, low-dose oral contraceptives etc This is due to the relatively
high failure rate and high incidences of irregular bleeding. The main aim of
emergency contraception is to put the decision of contraception in the hands
of women. In a patriarchal society like India, most women are not given the
right to ask their partners to exercise contraception as the onus is on the
woman to prevent pregnancies. 'morning after' pills, thus put another choice
within the woman's reach in case the contraception routine is accidentally broken.
They are not like normal contraceptives, according to Shalini Kaushik, Senior
Product Executive-Product Management Team, Mankind Pharma. "What distinguishes
the morning after pills from conventional contraceptive pills is the timing
of use. Morning after pills are used after unprotected intercourse within 72
hours, whereas other conventional contraceptives such as birth control pills
are taken regularly to prevent pregnancy," explains Kaushik.
Timing matters
The simple concept behind 'morning after' pills is that it is very effective
at reducing the risk of pregnancy when taken within 72 hours of unprotected
intercourse. Studies have shown that intake of emergency contraceptive tablets
reduce the risk of pregnancy upto 120 hours after unprotected intercourse, but
the sooner the dosing begins, the more effective the treatment will be. Dr Narendra
Malhotra, President Federation of Obstetrics and Gynaecological Societies of
India (FOGSI) 2008, says, "How these pills are different from the conventional
regime is that they have only one pill which has to be taken after an unprotected
intercourse within 72 hours, while conventional pills are a combination of oestrogen's
and progesterone's and are taken from day two of menses for 21 days cyclically.
The conventional pills stop ovulation, whereas emergency contraceptives or morning
after pills stop implantation." Emergency contraception gives the choice
to women with respect to contraception, but are they efficacious? Gulati points
out that these pills have little role after 72 hours, therefore when used mid-cycle,
one in every 20 women who use the pill is likely to conceive. Hence these pills
are not 100 percent effective. Therefore, the importance of 'follow-up' for
three-weeks must be clearly explained to users. "During this period, barrier
method (condoms) must be used and if the menstrual period does not start, then
the possibility of ectopic pregnancy or toxicity to the foetus needs to be assessed.
None of this essential, safety and efficacy information is included in the high-pitched
advertising blitz to promote sale of these pills,” says Gulati.
In the pill
Currently, two types of morning after pills are available: they are I-pill from
Cipla and Unwanted-72 from Mankind. In India, only levonorgestrel (LNG) is available
as a 'morning after' pill for example, Unwanted-72. Oestrogen alone is no longer
used because of its side effects and is now almost abandoned in favour of the
LNG regime. Gulati says that the equivalent tablet being sold in Western countries
contains 750mcg of the medicine while I-Pill contains double the dose ie 1500mcg.
In other countries, such as Britain, Australia etc, there are two dosage regimens:
two tablets of 750mcg, 12 hours apart or two tablets of 750mcg - i.e. 1500mcg
in one go. However he cautions by saying that it is not advisable to have two
tablets in the case of I-Pill because of it is a higher dose. The other problem
is that in the case of vomiting, the I-Pill will need to be taken again. Vomiting
with 1500mcg tablet is also more common than with 750mcg tablet when taken twice.
He further opines that the other brands available in India like Norlevo (Win
Medicare) and Ecee-2 (German Remedies) are better as they contain only 750mcg
of levonorgestrel.
How safe is it?
The debate on the safety of emergency contraceptive pills has been going on
for some time now. Listing the side effects of I-Pill and Unwanted-72, Gulati
says they include ectopic pregnancy, vomiting, nausea, fatigue, abdominal pain,
gastrointestinal upsets, diarrhoea, dizziness, headache, breast tenderness,
early/late onset of next period, increased menstrual bleeding, vaginal haemorrhage
etc. Severe side effects are relatively rare in women who are healthy and those
who do not smoke while on LNG emergency contraceptives. The effects of the pills
defer from person to person, thus making it nearly impossible to predict which
users will have nausea or vomiting or which women will benefit from antiemetic
pre-treatment. Malhotra however downplays these side effects saying, "Morning
after pills are safe apart from minor side effects of nausea, vomiting etc.
Apart from these, there are no known side effects if the pills are administered
properly. These side effects are sometimes found with normal birth control pills
as well." He adds that though these pills are used to stop pregnancy they
are definitely not abortion pills.
Is OTC the right move?
There is a strong move all across the world to make emergency contraception
an over the counter (OTC) drug. Kaushik feels that there should not be any issues
in positioning emergency pills as an OTC product, since even the US Food and
Drug Administration (FDA) has approved LNG as an OTC product for females above
the age of 18 years. Malhotra too believes that any form of contraception should
be available OTC and should be promoted among the masses. However Gulati disputes
this reasoning, saying that rather than preventing unwanted pregnancies this
move will only give the wrong message to teenagers. In countries like Britain
where emergency contraceptive pills are prescription medicines, there has been
increasing use of these pills by teenagers which has posed a serious challenge.
Apart from that, making these pills OTC will also indirectly discourage the
use of condoms, which is very dangerous because emergency pills do not prevent
sexually transmitted diseases likes AIDS etc. Some experts estimate that widespread
use of emergency contraception could prevent as many as half of the unintended
pregnancies that occur each year, including as many pregnancies that now result
in abortion. However Gulati points out that there are other more fundamental,
ethical, clinical and legal issues involved in the approval and mass media promotion
of products such as I-Pill.
Gulati adds, "It is most surprising that the Drugs Controller General,
India (DCGI) has allowed its sale through OTC and permitted its publicity in
mass media despite absence of mandatory clinical trails in India." He also
points out that I-Pill advertisements are also misleading as they do not give
information on precautions and side effects and do not stress the importance
of timing. Gulati believes that a copper-bearing Intra-Uterine Device (IUD)
offers a much safer and more effective method of contraception.
Pregnancies following unprotected sex are vastly damaging and should be prevented
by emergency contraceptive measures. Unfortunately, in our
country, awareness and knowledge levels on these medications is very low. "A
rise in use of emergency contraception is good, but there should be lot of awareness
campaigns so that they are not misused on a regular basis," concludes Malhotra.
suja.nair@expressindia.com
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