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Esmya (ulipristal acetate) - MHRA safety alert

Posted , 4 users are following.

mariauk
mariauk

Dear ladies, 

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,

Mariu

0 likes, 4 replies

4 Replies

  • shell69386
    shell69386 mariauk

    Posted

    Thank you for sharing this. I took two courses almost 2 years ago. Hopefully there have been no repercussions.  It is a shame and I hope they discover it is still safe to take as it was a non-surgical option for fibroids and I was pleased to discover it and it may have helped a lot of women.  I took up Reiki after I stopped and touch wood I have been well. 
  • jo37069
    jo37069 mariauk

    Posted

    I received the same letter last week!! What I don't understand is why we were not informed before being prescribed this dangerous drug ??? And why are we being used  as guinea pigs by telling us to continue to take it knowing the detrimental effects it can have on the liver??

    • mariauk
      mariauk jo37069

      Posted

      I think that when we were prescribed Esmya it was no known that could have dangerous side effects. All drugs need to have pharmacovigilance, which means they collect information about efficacy and more importantly, side effects in users.

      Not all women treated will have liver problems, I didn’t, and if controlled the positive effects of Esmya might be worthwhile.

      The list of medical or non invasive treatments for fibroids is rather short ☹️

    • julie51050
      julie51050 mariauk

      Posted

      Thank You for sharing this I'm about to start my 3rd course of Esmya and no one has contacted me yet. Im 53 and from the uk and my gyno prescribed them for me at xmas ready for me to start them in January however my period hasn't arrived yet so maybe thats a blessing. Going to ring the doctors tomorrow though to see if I am able to have a blood test to check liver . x

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