Dear Healthcare professional Letter on the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol
19.03.2015
Remedia d.o.o. , in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) is sending a letter to healthcare professionals to inform them of the new measures associated with the use of Linoladiol 0.01% vaginal cream (estradiol) due to a potential risk of systemic adverse reactions to estradiol.
Summary
The European Medicines Agency (EMA) has concluded that due to a relatively high estradiol content, this medicines bears a potential risk of adverse reactions caused by systemic estradiol absorption.
Indications are restricted to the treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women (without application to vulva)
The treatment duration is restricted to no more than four weeks. In accordance with this, a pack size of 25 g cream, will be introduced, followed by revocation of 50 g packs.
contraindications, warnings, precautionary measures and other information are supplemented with the data on new potential risks and are available in the summary of product characteristics and package leaflet accessible in the Medicines Database section of the HALMED webpages.
Further information
A safety review of the use of this medicine has been conducted at the EU level at the EMA due to concerns of potential adverse reactions caused by a systemic estradiol absorption. This issue has been discussed due to the fact that medicines with a high estradiol content for local use may lead to an estradiol blood level that is comparable to that after the use of medicines with estradiol for systemic use. It is concluded that the systemic estradiol absorption may potentially be associated with the risks that are similar to those medicines for hormone replacement therapy and that include thrombosis, stroke and endometrial cancer.
Linoladiol 0.01% vaginal cream is marketed (under various names) for more than 40 years in Europe. The risk of systemic adverse reactions due to a relatively high estradiol content associated with the use of this medicine is considered potential.
It is concluded in this procedure that, in addition to the above measures, the benefits and risks ratio of the use of this medicine remains positive.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
