Adapalen (a substance that causes swelling in creams)

History

2023: Russian Ministry of Health warns acne creams can cause angioedema

In January 2023, it became known about a new side effect in drugs for acne based on adapalene. It turned out that this substance can have an undesirable effect on the immune system and skin. The Ministry of Health of the Russian Federation asked manufacturers to warn doctors and patients about this.

Adapalene-based acne gels can cause a dangerous risk of choking angioedema (also known as Quinke's oedema), as well as swelling of the face and lips. This was reported in an official letter from the Department for Regulation of the Circulation of Medicines and Medical Devices of the Ministry of Health of Russia to the manufacturers of such drugs. In it, manufacturers of drugs with adapalene are asked to make appropriate warnings to their instructions. The document is published on the website of the State Register of Medicines.

Adapalene-based acne creams can cause Quinke swelling

The letter clarifies that the reason for the warning was the data obtained "during the preparation of requirements for the safety and effectiveness of drugs based on modern scientifically based information on the experience of clinical use of drugs containing adapalen as an active substance." The Scientific Center for the Examination of Medical Products of the Ministry of Health, whose letter is also attached to the department's document, announced the receipt of such data.

Adapalen is indicated for the treatment of mild to moderate acne, including accompanied by comedones, papules and pustules. Several brands of drugs containing this substance are registered in Russia.

This is a gel for external use Adolen of Russian production (manufactured by the Synthesis company), Adaklin cream of the Indian company Sun Pharma, Dim'in gel and cream of Swiss Galderm, Klenzit gel from Glenmark (India). It is also part of multicomponent preparations in the form of gel: Clenzit-S and Clenzit-S microspheres (Glenmark), Metrogil A (Unik Pharmaceutical Laboratories, India) and Effezel from Galderm. By January 2023, there is no corresponding warning in the instructions for these drugs, and it should be introduced, the Ministry of Health emphasized.^[1]

Notes