23.05.2024 Midazolam içeren İlaçlar Acil Güvenlilik Kısıtlaması Görüş-Katkı_EN

Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

Number: E-24931227-510.01.04-1487589 23.05.2024 Subject: Midazolam-containing drugs / Urgent
Safety Restriction / Call for Opinions/Suggestions

DOSSIER

We have given consideration to the warnings for “Kounis Syndrome,” which the European Medicines Agency (EMA), Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Medicinal Products for Human Use (CHMP) required to be included in product information of products containing midazolam (for all pharmaceutical forms and therapeutic indications, excluding oromucosal solution indicated for the treatment of prolonged, acute, convulsive seizures), and decided that the wording provided in the attachment must be incorporated in the local summary of product characteristics (KÜB) and local package leaflet (KÜB) of the aforesaid products.
Please forward any opinions, suggestions or contributions which you may have regarding the decision taken to the Pharmacovigilance Risk Management Unit of the Pharmacovigilance and Controlled Substances Department by 17.06.2024, and refrain from making any submissions to the Pharmacological Assessment Unit in the mean time.
For your information and appropriate action.

Dr. Asım Hocaoğlu Agency President

Distribution: Turkish Pharmaceutical Manufacturers’ Association Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers’ Association of Türkiye Health Products Association

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Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through).

Local Summary of Product Characteristics (KÜB)

4.8 Undesirable effects The following adverse reaction should be added under the System Organ Class “Cardiac disease” with a frequency of “Not known.”

Kounis syndrome*

*particularly before parenteral administration.

Local Package Leaflet (KT)

4. Possible side effects

[…]

Oral formulations:

Immune system disorders; Susceptible persons may experience hypersensitivity reactions and angioedema.

Chest pain has been observed, as a sign of a serious allergic reaction called the Kounis syndrome.

All other pharmaceutical forms (excluding oral formulations):

[…]

If you experience any of the following, stop taking and IMMEDIATELY see your doctor or seek urgent medical attention at the nearest hospital:

Anaphylactic shock (a life-threatening allergic reaction). Signs may include a sudden rash, itching or lumpy rash (hives) and swelling of the face, lips, tongue or other parts of the body. You may also have shortness of breath, wheezing or trouble breathing, a pale skin, a weak and rapid pulse or loss of consciousness. Additionally, you may experience chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

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