
New safety information about diltiazem
At the end of June 2023, a letter from the Ministry of Health of the Russian Federation was published on the GRLS website containing recommendations for amending the documentation for healthcare professionals and patients.
Diltiazem is used to treat stable angina and hypertension. The drug expands the coronary and peripheral arteries and arterioles, reduces the total peripheral vascular resistance, smooth muscle tone, and reduces the heart rate. According to the state register, 4 trade names of diltiazem are currently registered in the Russian Federation: 1 manufactured in Russia, as well as 3 drugs manufactured in North Macedonia and Romania.
The changes indicated by the Ministry of Health of the Russian Federation relate to safety. In particular, diltiazem has been found to be a cause of acute renal failure. In this regard, the MoH recommends to add additional information on cases of acute renal failure in patients with heart disease, especially with reduced left ventricular function, severe bradycardia, or severe arterial hypotension. For such patients, careful monitoring of renal function is recommended.
In addition, it is recommended to add information to the “Side effect” section that diltiazem can cause a lupus-like syndrome, which is usually manifested by inflammation and pain in the joints and muscles, in the chest area, skin rashes, fatigue, fever body. In addition, in the abovementioned section, it is recommended to note that the incidence of lupus-like syndrome is unknown.
It also became known about the possible negative consequences of the concominant use of diltiazem and lomitapide (a drug that regulates the level of cholesterol in the blood, used, among other things, to treat familial hypercholesterolemia). In particular, diltiazem is able to increase the concentration of lomitapide in the blood, which can lead to an increase in the likelihood and severity of liver side effects.
Similar recommendations appeared on the EMA website for diltiazem in the spring of 2023. Marketing authorization holders were required to submit a dossier for amendments to the SmPC and PL by May 11, 2023.
References:
- https://grls.rosminzdrav.ru/Forum/Files/244672/%D0%9F%D0%B8%D1%81%D1%8C%D0%BC%D0%BE%20%D0%BE%D1%82%2028.06.2023%20%E2%84%9625-6_5942.pdf
- https://pharmvestnik.ru/content/news/Diltiazem-mojet-vyzyvat-ostruu-pochechnuu-nedostatochnost.html
- https://www.ema.europa.eu/en/documents/psusa/diltiazem-cmdh-scientific-conclusions-grounds-variation-terms-marketing-authorisation-psusa/00001084/202205_en.pdf