Emergency Contraception and Body Weight
Author: Dr. Deirdre Lundy
Tutor and course coordinator, Women's Health Programme, ICGP
January 2014
Background
In November of 2013, HRA Pharma altered the Summary of Product Characteristics (SmPC) for
"Norlevo" progestagen- only emergency contraception (EC) that is sold in France. It urged "caution
in dispensing levonorgestrel to women over 75 kg". This decision was based on data gathered by
HRA Pharma itself and submitted to the European regulatory authority early in 2013. There are no
new, peer- reviewed, published data regarding the efficacy of levonorgestrel ECP in women over 75
kg.
The UK Faculty of Sexual & Reproductive Health responded to the change to Norlevo SmPC in
Europe, by releasing a statement in November 2013. 1 They are advised members to refer to the
original; albeit small, data gathered and published in 2011 in their journal "Contraception".2 In this,
data from randomized trials of ulipristal acetate and levonorgestrel showed that obese women (BMI
>30) using levonorgestrel EC were at greater risk of pregnancy compared to those using
levonorgestrel EC with a normal or low BMI. That study also noted that an increased risk was also
noticed amongst ulipristal acetate (ellaOne) users but the difference was not statistically significant.
The numbers of women falling pregnant using either method was small (n = 60) and even smaller
among obese women (n = 20, 6/227 UPA, 14/242 LNG).
As these numbers were so small the FSRH agreed that more evidence was required before specific
recommendations could be made for obese women. They supported the use of all EC methods in
obese women. As of February 2014 this has not changed. The FSRH recommendations are that "
women requesting emergency contraception should be informed about all available methods and
that all eligible women should be offered the copper intrauterine device as it is considered the most
effective method of EC due to the low documented failure rate".
The Situation in Ireland
In November 2013, the Irish Medicines Board approved a new Summary of Product Characteristics
for Norlevo.3 This states that “In clinical trials, contraceptive efficacy was reduced in women
weighing 75kg or more, and levonorgestrel was not effective in women who weighed more than
80kg.”
Following that, the Irish Pharmacists Union (IPU) has advised its members to "refer women over 75
kg to their GP or family planning clinic for alternative emergency contraception such as ellaOne or
the coil, both of which are effective up to 5 days after unprotected intercourse “.
The change to the IPU levonorgestrel sales protocol now means that some women over 75 kg will be
referred from the pharmacy to their GP for emergency contraception.
Prescribing Emergency Contraception in General Practice
A woman who presents to general practice seeking the Emergency contraception can be told the
following:
1. They can be told that the most reliable form of EC is to have a copper bearing intrauterine
device inserted up to 5 days post unprotected sexual intercourse (or up to 5 days after
expected day of ovulation). This information is based on the 2012 data published in the BMJ.
4
GPs who do not insert Copper IUDs for this indication should have a clear referral pathway
to a GP or family planning doctor who does provide this service should the woman choose
this option.
2. Women can be informed that there are two types of EC medications available in Ireland: the
levonorgestrel -containing pills Norlevo and Levonelle and the ulipristal acetate pill known
as ellaOne. They should be told that there is evidence to suggest that ellaOne is more
effective than either Norlevo or Levonelle and that ellaOne's effectiveness stays high for 5
days after unprotected sex whereas the levonorgestrel products become less effective the
longer you delay in taking it. There are more minor side effects listed after using ellaOne
including menstrual type cramps. 4
3. Women can also be told that the manufacturer of levonorgestrel has suggested that there is
limited research to confirm the effectiveness of the levonorgestrel products in women over
75 kg and for this reason women who weight over 75kg might choose one of the
alternatives.
References
1. Statement from Clinical Effectiveness Unit on Labelling of Levonorgestrel emergency
contraception in Europe: reports of new advice on body weight and efficacy. Faculty of
Reproductive and Sexual Healthcare. November 2013.
http://www.fsrh.org/pdfs/CEUstatementLabellingLevonorgestrelEmergencyContraceptionEu
rope.pdf
2. Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, et al. Can we identify women
at risk of pregnancy despite using emergency contraception? Data from randomised trials of
ulipristal acetate and levonorgestrel. Contraception 2011; 84: 363-7
3. Norlevo. Summary of product characteristics .
http://www.imb.ie/images/uploaded/swedocuments/LicenseSPC_PA1166-001001_28112013160045.pdf
4. Prabakar I, Webb A .Emergency Contraception. BMJ. March 2012; 344 e 1492.
Further Reading
1. Lundy D. Options for Emergency Contraception in Ireland. Forum. August 2012.
http://www.icgp.ie/assets/60/E6960E39-19B9-E18583E68F10467D12A4_document/WH_47-8.pdf
2.
Faculty of Sexual and Reproductive Health Care clinical Effectiveness Unit. Emergency
Contraception August 2011.
http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf