EMA recommends updating safety information for HRT and leuprorelin

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the current safety information for hormone replacement therapy (HRT) used to treat symptoms of the menopause.

The updates are based on evidence from a large study published in The Lancet in August 2019, which confirmed the known higher risk of breast cancer in women using HRT. Furthermore, the results showed that the risk may continue to be increased for 10 years or more after stopping HRT, if it has been used for more than five years.

Having assessed all available evidence, the PRAC recommends changes in the product information for implementation by authorities to reflect the following updates:

• For combined oestrogen-progestagen and oestrogen-only HRT, the updated product information will reflect that the known higher risk of breast cancer in women using HRT becomes clear after approximately three years of use. The new information indicates that the risk may persist for 10 years or more in women who have used HRT for more than five years.

• For conjugated oestrogens/bazedoxifene (Duavive), the effect on the risk of breast cancer is unknown. However, as Duavive contains conjugated oestrogens, the product information will be updated to reflect the new information related to oestrogen-only therapy.

• For tibolone-containing HRT, the updated product information will reflect that no data for persistence of risk after stopping treatment are available, but a similar pattern cannot be ruled out

• For low dose vaginally applied oestrogen, the product information will be updated to reflect that the evidence has not shown an increase in breast cancer risk in women who had no breast cancer in the past. It is not known if it can be safely used in women who had breast cancer in the past.

The PRAC is also recommending measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines which are used to treat prostate cancer, breast cancer, certain conditions that affect the female reproductive system and early puberty.

A review by the PRAC found that some handling errors, such as the incorrect use of the needle or syringe, causing the medicine to leak from the syringe and failure to inject leuprorelin properly, resulted in some patients receiving insufficient amounts of their medicine.

The committee is therefore recommending that only healthcare professionals familiar with the preparation and administration steps should handle and administer the medicines to patients and patients should not prepare or inject these medicines themselves.