EMA has recommended healthcare professionals refrain from using Esmya
For women suffering from fibroids (non-cancerous tumours), every day could be physical and emotional agony. And many of these women don’t want to go under the knife just to take out their fibroids or lose their uterus for a lot of reasons. This is why non-surgical approaches to treating fibroids make it a reasonable alternative for women.
Among the few non-surgical options available, taking oral medication to shrink fibroids could be the easiest and most convenient treatment there is. Recently, a new fibroid-shrinking drug called ulipristal acetate under the brand name Esmya has been made available to patients with a promising efficacy to remove the need for future surgical fibroid treatment. However, Esmya was removed from the market following safety concerns regarding liver toxicity requiring transplantation.
Regulators from the European Medicines Agency (EMA) are currently reviewing the benefits and risks of Esmya usage and have advised patients and healthcare providers to follow specific temporary safety measures to minimise potential risks to patients.
In the meantime, the EMA has recommended healthcare professionals to refrain from using Esmya to treat new patients and those who have already finished previous treatments with said pill.
As for women who are currently taking Esmya for uterine fibroids, they are advised to monitor their liver function at least once a month during treatment. If they ever experience symptoms related to liver problems like nausea, vomiting, yellowing skin or eyes, anorexia, weakness, and upper abdominal pain, they must stop treatment and seek medical help right away. Liver tests are also highly advised to be repeated 2 – 4 weeks after stopping treatment.
With this impending health and safety risk and concern, what could be the best treatment for fibroids? In the past, the only possible options involved major surgeries such as removal of fibroids (myomectomy) and removal of the whole uterus (hysterectomy). These treatments require general anaesthetic, a longer hospital stay and recovery period, and a higher risk of complications compared with today’s available non-surgical treatments.
One non-surgical treatment option is uterine fibroid embolisation (UFE), which shrinks fibroids by placing tiny ‘plastic’ particles into the artery that feeds the fibroids. This blocks the blood supply of fibroids, causing them to shrink. The procedure is relatively simple and minimally invasive, performed under local anaesthetic. It requires a 1-night stay in hospital and 1-week of recovery.