EU safety experts begin review of leuprorelin-containing drugs

European safety experts are to begin a review of leuprorelin-containing medicines, commonly used in breast and prostate cancer and as a contraceptive.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) said that the review had been sparked by reports that handling errors during preparation and administration can cause patients to receive insufficient amounts of the medicine, reducing its benefit.

In a statement, the EMA said healthcare professionals should carefully follow handling instructions for leuprorelin medicines, and anyone with concerns should discuss them with their doctor.

Takeda markets a leuprorelin-containing medicine in the UK, Prostap SR, which is a powder and solvent administered for long release in a pre-filled syringe to treat prostate cancer.

It is a synthetic hormone used to reduce levels of testosterone and oestrogen circulating in the body.

The drug can also be used to treat hormone responsive early stage breast cancer in pre and perimenopausal women at higher risk of recurrence, and hormone response advanced breast cancer in pre and perimenopausal women.

It can also be used in women to reduce thickness of the lining of the womb in preparation for surgery and to treat endometriosis and uterine fibroids.

Another use is for ovarian function pre-menopausal women with cancer who are having chemotherapy, and to stave off early puberty.

The drug was first marketed in 1985, initially as a daily injection, with a depot injection formulation introduced four years later.

Last month the PRAC said that Pfizer’z Xeljanz (tofacitinib) should not be used in a higher dose in some patients with ulcerative colitis.

The PRAC made its decision because of concerns of increased risk of blood clots on the lung and increased mortality.

The committee is restricting prescription of Xeljanz, preventing new patients with ulcerative colitis and high risk of pulmonary embolism from starting on the drug.