The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) have unveiled highlights of their meeting from 30th September – 3rd October 2019.
The outstanding highlight from this meeting was regarding creams containing 100micrograms/gram (0.01%) estradiol. The PRAC concluded a referral from April 2019, recommending that these high strength hormone replacement creams are limited to a single treatment period of up to four weeks.
After reviewing safety and efficacy data, the PRAC found that blood levels of estradiol in postmenopausal women were higher than normal, leading to concerns that prolonged absorption of estradiol into the blood could lead to similar side effects associated with oral hormone replacement therapy (HRT), such as venous thromboembolism, stroke or even breast cancer.
Furthermore, healthcare professionals have been advised to avoid co-prescribing these creams with other HRT medicines. The prescribing information will be updated with the new guidelines and a warning will be placed on the inner and outer packaging of such products. Also, the size of the tube will be limited to 25g to reduce the risk of prolonged use. The PRAC recommendations will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) to confirm their implementation.
Six other referrals are still under evaluation by the PRAC including cyproterone, fluorouracil-related substances, Lemtrada, leuprorelin-containing products, Picato and Xeljanz. The PRAC also highlighted nine safety signal assessments, sixty-eight single assessment periodic safety update reports (PSUR), sixty risk management plans (RMP) for centrally authorised medicines, and twenty-one post-authorisation safety studies (PASS).
To view the full highlights and statistics from the PRAC’s meeting click here.