The European Medicines Agency (EMA) has recommended limiting the use of high-strength vaginal creams containing 100 micrograms/gram (0.01%) of oestradiol to a single treatment period of up to four weeks. The measure is intended to minimise the risk of side effects from oestradiol absorbed into the bloodstream from creams applied to treat symptoms of vaginal atrophy in postmenopausal women.
The recommendation follows a ruling by the EU Court of Justice earlier this year that partially annulled the conclusions of a previous review of these medicines in 2014 on procedural grounds. Although the Court of Justice did not question the scientific conclusions, the partial annulment meant that some of the measures taken to minimise the risk were invalidated.
The EMA says the Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed all available data on the safety and effectiveness of high-strength oestradiol-containing creams and has found that the data showed that use was associated with higher serum levels of oestradiol in postmenopausal women.
The prescribing information for these creams will now be updated with the new recommendations, and the size of the tube will be limited to 25 grams to prevent use for longer than recommended.