"Morning-after pill" remains appropriate emergency contraception in every weight class
The European Medicines Agency (EMA) has completed the Article 31 procedure under Directive 2001/83 EC to assess whether higher body weight or a higher body mass index (BMI) could lead to reduced efficacy of the "morning-after pill" preparations approved in Austria or Europe.
"Morning-after pill" preparations are used for emergency contraception to prevent pregnancy after unprotected sexual intercourse or failure of a contraceptive method. The products concerned are levonorgestrel-containing preparations (Vikela, Postinor, Levodonna, Velafam) and an ulipristal-containing preparation (ellaOne).
The following drug products are approved in Austria:
Vikela 750 microgram tablets.
Vikela 1.5 mg tablet
Postinor 1500 microgram tablet
Levodonna 1500 microgram tablet
Velafam 750 microgram tablet
Velafam 1.5 mg tablet
ellaOne 30 mg tablet
The EMA's Committee for Medicinal Products for Human Use has now confirmed that the benefits of emergency contraception outweigh the risks and that the "morning after pill" can be used in women regardless of their weight or BMI. Previous information that levonorgestrel-containing emergency contraception would have been worse above 75 kg body weight and ineffective above 80 kg body weight is therefore no longer valid and will be amended. Although there is slight evidence of worse efficacy at higher body weight, the data from these studies are insufficient and weak, and are also not supported by other studies. Therefore, a worse effect at higher body weight or BMI cannot be claimed with certainty. This applies to both levenorgestrel-containing and ulipristal-containing emergency contraception.
The potential for side effects of all morning-after pill preparations is considered low, the safety profile therefore favorable, and the preparations can be used in the future by all women regardless of their weight or BMI. The morning-after pill should be used as soon as possible after unprotected sexual intercourse for optimal efficacy. However, it must be expressly emphasized that the morning-after pill is only a sporadic contraceptive measure that is in no way intended to replace conventional contraception.
Recommendations of the BASG
Recommendations for patients:
- Emergency contraception with the morning-after pill can be used to prevent unintended pregnancies after unprotected sexual intercourse or after a contraceptive breakdown.
- An EU-wide evaluation of clinical data could not show with certainty that higher body weight actually leads to poorer efficacy.
- The morning-after pill can therefore be used by women regardless of their weight. Nevertheless, care should be taken to ensure that the emergency contraception is taken as soon as possible after unprotected sexual intercourse in order to ensure optimal effectiveness.
- The morning-after pill is a sporadic contraceptive measure that must not be used regularly under any circumstances and cannot replace a conventional contraceptive method.
Recommendations for physicians and pharmacists:
- Emergency contraceptive pills containing the active ingredient levenorgestrel, as well as ulipristal, can be used to prevent unintended pregnancy in women of any weight or BMI. Existing data are not robust enough to confirm a worse effect with higher body weight or BMI.
- For levenorgestrel, the following data were assessed: on the one hand, a meta-analysis of two published studies conducted mainly in Caucasian women. This showed somewhat reduced efficacy at higher body weight (pregnancy rate 0.96% [CI: 0.44-1.82] in women with a BMI of 18.5-25; 2.36% [CI: 1.02-4.60] in women with a BMI of 25-30; and 5.19% [CI: 2.62-9.09] in women with a BMI ≥30). On the other hand, a meta-analysis of three WHO studies, conducted mainly in African and Asian women, refuted the results shown above and showed no evidence of a worse effect with increasing body weight (pregnancy rate 0.99% [CI: 0.70-1.35] in women with a BMI of 18.5-25; 0.57% [CI: 0.21-1.24] in women with a BMI of 25-30; and 1.17% [CI: 0.24-3.39] in women with a BMI ≥30).
- For ulipristal, the following data were assessed: a meta-analysis conducted for four studies submitted at the time of approval. Showed only a weak, nonsignificant trend for limited effect with higher body weight (pregnancy rate 1.23% [CI: 0.78-1.84] in women with a BMI of 18.5-25; 1.29% [CI: 0.59-2.43] in women with a BMI of 25-30; and 2.57% [CI: 1.34-4.45] in women with a BMI ≥30).
Further information:
European Medicines Agency press release (07/25/2014).
Press release of the European Medicines Agency (24.01.2014) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/01/news_detail_002010.jsp&mid=WC0b01ac058004d5c1
Press release from the Federal Agency for Safety in Health Care (01/24/2014).
<link news-center/news/safety-information-details/article/-7f182c07f9/>http://www.basg.gv.at/news-center/news/sicherheitsinformationen-details/article/-7f182c07f9/
Queries (technical):
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: 050555/25000
E-mail: presse@ages.at
