Levonorgestrel and Ulipristal are suitable emergency contraceptives for all women regardless of body weight

On July 24 2014, the European Medicines Agency (EMA) released a review entitled 'Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight'. ¹

This follows a review of emergency contraceptives to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected intercourse or contraceptive failure. The EMA recommends that these emergency contraceptives can continue to be used on women of all weights as the benefits are considered to outweigh the risks.

In November 2013, following approval from the Irish Medicines Board, the product information of Norlevo (levonorgestrel) was altered, stating that clinical efficacy was reduced in women weighing 75kg or more and that levonorgestrel was not effective in women who weighed more than 80kg. Following this announcement, the Irish Pharmacists Union(IPU) 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.

The European medicines Agency have looked at all available studies and concluded that the data was "too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo "and that the newly added statements on the impact of bodyweight in the product information for Norlevo should be deleted.

The Health Products Regulatory Authority (HPRA) now recommends that "emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index." ²

What to tell your patients?

A woman who presents to general practice seeking emergency contraception can be told the following:

1. Women can be informed 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.
   Copper coils are available in Ireland and although no one particular brand holds an Irish license, most hold European licenses and can be offered for sale and insertion in this country. They come in variety of sizes (to suit the size and parity of the patient) and are available in some pharmacies for as little as €25. While there is a slight increase in uterine infection rate for the 3 weeks after insertion, this returns to background thereafter. Unprotected sex is a risk factor for a sexually transmitted infection so when offering a post coital copper coil insertion it is advisable to swab the patient at that time and possibly again 3 to 4 weeks after fitting. It is not necessary to routinely cover with antibiotics at the time of insertion. The device may be left in situ if the patient wishes or it can be removed after the next menstrual bleed and following a negative pregnancy test.
2. Women can be informed that there are two types of emergency contraception medications available in Ireland: the levonorgestrel -containing pills 'Norlevo' and 'Levonelle' and the ulipristal acetate pill known as' ellaOne'. Both can be prescribed to women of any weight or BMI. Women can 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. ³

References

1. European Medicines Agency Statement - Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight. July 2014.
2. Statement from the Health Products Regulatory Authority
   
3. Prabakar I, Webb An .Emergency Contraception. BMJ. March 2012; 344 e 1492.

Further Reading

1. Faculty of Sexual and Reproductive Health Care clinical Effectiveness Unit. Emergency Contraception, August 2011. http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf.