post-bg-531
calendary September 1, 2023

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:
  1. 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
  2. https://pharmvestnik.ru/content/news/Diltiazem-mojet-vyzyvat-ostruu-pochechnuu-nedostatochnost.html
  3. https://www.ema.europa.eu/en/documents/psusa/diltiazem-cmdh-scientific-conclusions-grounds-variation-terms-marketing-authorisation-psusa/00001084/202205_en.pdf

More related posts

new-img-1

Control

Fine for spa resort in Yessentuki

Roszdravnadzor has imposed a fine of 130 thousand rubles on a spa resort in Yessentuki for improper storage of medical products…

03.03.2016
READ ARTICLE
new-img-2

Roszdravnadzor

Roszdravnadzor – patients’ rights

In 2015, Roszdravnadzor restored the rights of more than 460 thousand citizens to effective, accessible, and safe medical…

03.03.2016
READ ARTICLE
new-img-3

Regulation

The certification scheme for medical products hasn’t changed recently

Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the…

03.04.2016
READ ARTICLE
new-img-4

Control

Fines – Rostov region

In one and a half months of 2016, the Local Agency of Roszdravnadzor in Rostov Region imposed fines of the total amount of…

03.10.2016
READ ARTICLE
new-img-5

Control

Unregistered medical products

Two citizens were fined for selling unregistered medicinal products on the Internet in the Republic of Bashkortostan.

03.10.2016
READ ARTICLE
new-img-6

Control

Unscheduled inspection by roszdravnadzor

Roszdravnadzor started an unscheduled inspection of the Federal State-Funded Institution of Sverdlovsk Region Kirovgrad Central…

03.14.2016
READ ARTICLE
new-img-7

Medical Devices

International medical device regulators forum (IMDRF)

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor,…

03.17.2016
READ ARTICLE
new-img-8

Pharmaceuticals

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF”

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF” in which pills the metal wire was found.

05.18.2016
READ ARTICLE
new-img-9

Roszdravnadzor

Medical equipment stands idle in the Pskov region

Roszdravnadzor (RZN) statement: the expensive medical equipment for the total amount of 342 million rubles stands idle in…

05.19.2016
READ ARTICLE
new-img-10

Control

Hospital control Jewish autonomous region

Roszdravnadzor has audited the activity of the Regional Budgetary Public Health Facility “Central district hospital of Lenin”…

05.20.2016
READ ARTICLE