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I know many of you are undergoing medical treatment with Esmya or other ulipristal acetate brands for your fibroids. I've just got a letter from my gynecologist explaining the following:
On 9 February 2018 the Medicines & Healthcare products Regulatory Agency (MHRA) advised of new temporary safety measures for Esmya (ulipristal acetate) following reports of serious liver injury in women using the medicine for uterine fibroids.
The temporary safety measures are:
Do not initiate new treatment courses of Esmya, including in women who have completed one or more treatment courses previously.
Perform liver function tests at least once a month in all women currently taking Esmya. Stop Esmya treatment in any woman who develops transaminase levels more than 2 times the upper limit of normal, closely monitor and refer for specialist hepatology evaluation as clinically indicated. Liver function tests should be repeated in all women 2 to 4 weeks after stopping treatment.
Check transaminase levels immediately in current or recent users of Esmya who present with signs or symptoms suggestive of liver injury (such as nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia, jaundice). If transaminase levels are more than 2 times the upper limit of normal, stop treatment, closely monitor and refer for specialist hepatology evaluation as clinically indicated.
Advise women using Esmya on the signs and symptoms of liver injury.
I you google Esmya FDA (if you're in US) or Esmya EMA (If you're in Europe) you'll find websites with more information. But I would encourage you ladies to talk to your GPs or gynecologist asap if you're currently under treatment.
All the best,
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