A limit to the duration of use and other measures put in place to manage potential risk of side effects
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.
The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area. Treatment with both creams should be limited to a maximum duration of 4 weeks.
In addition, Linoladiol HN is no longer to be used to treat lichen sclerosus, a skin condition that commonly affects the genital area, because of a lack of evidence of benefit in this condition.
In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use. Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have now been updated, taking into account new measures to manage the potential risk of side effects.
The CHMP reiterates the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body). Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer. The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.
In addition, for Linoladiol N, the cream with the higher amount of estradiol, theCHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.
The CHMP’s recommendations will now be sent to the European Commission for the adoption of a final, legally binding decision to be valid throughout the EU.