The Main Pharmaceutical Inspectorate issued a decision to suspend medicinal products containing 5 mg ulipristal acetate on the market. These are the drugs Esmya, Uliprostal, Ulimyo and Ulipristal Alvogen.
Suspension of drugs with ulipristal acetate
The Main Pharmaceutical Inspectorate issued four decisions to suspend the sale of medicinal products containing ulipristal acetate (5 mg) – Esmya, Uliprostal, Ulimyo and Ulipristal Alvogen. The reason for the suspension of these drugs on the market is the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC).
Based on a review of the data, the committee issued a recommendation that Esmaya be suspended. The drug is used to treat uterine fibroids. The suspension is due to the appearance of severe new liver damage that required liver transplantation.
GIF issued a decision to suspend all series of medicinal products containing ulipristal acetate on the market:
- Esmya, Marketing Authorization Holder: Gedeon Richter Plc. Hungary
- Ulipristal Acetate Gedeon Richter, Marketing Authorization Holder: Gedeon Richter Plc. Hungary
- Ulimyo, Marketing Authorization Holder: Aristo Pharma GmbH, Germany
- Ulipristal Alvogen, Marketing Authorization Holder: Alvogen Pharma Trading Europe EOOD, Bulgaria
The decision is immediately enforceable.
Ulipristal acetate is controversial
The active substance ulipristal acetate has recently been approved for the pre-operative treatment of uterine fibroids. From the beginning, the use of this substance aroused controversy. In 2017, the European Medicines Agency (EMA) had serious concerns about Esmya related to an increased risk of liver damage in patients who used it. Monthly liver function tests are recommended for patients using this medicine. Each package of the drug was accompanied by a Patient Card containing basic information about the drug, indications for use, information on blood tests and a list of symptoms that should be consulted with a doctor.
According to the PRAC opinion, the implemented security measures (i.e. the Card for a Platinum Patient) are not sufficient, which resulted in issuing a recommendation to suspend the above-mentioned medicinal products on the market.
Uliprestal acetate is also often used as an active ingredient in contraceptive drugs, especially in the so-called emergency contraception (“pill after”).
The editorial board recommends:
- Vitamin D reduces the risk of uterine fibroids
- Menstrual disorders – it does not have to be a symptom of menopause
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