EMA issues safety alert on use of high-strength oestradiol creams

EMA has issued safety alert on use of high-strength oestradiol creams for vaginal atrophy.

The European Medicines Agency (EMA) has recommended that the use of high-strength oestradiol-containing creams, Linoladiol N and Linoladiol HN should be restricted.

Linoladiol N is only to be used intra-vaginally for post-menopausal women with vaginal atrophy due to oestrogen deprivation, while Linoladiol HN can be used for post-menopausal women with mild inflammatory skin conditions around the genital area.

The EMA advice is that treatment with both creams should be limited to a maximum duration of four weeks.

Linoladiol HN is no longer to be used to treat lichen sclerosus, because of a lack of evidence showing benefit.

n addition, the EMA has instructed the manufacturers of Linoladiol N to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.

In 2014, the EMA completed a review of the risk of systemic absorption with high-strength oestradiol creams and recommended measures to minimise it. However, in March 2019, the EU Court of Justice partially annulled the conclusions of the review on procedural grounds. Although the Court did not question the scientific conclusions, the partial annulment means that some of the measures taken to minimise the risk have been invalidated. The European Commission has therefore asked the EMA to re-assess the risk.