Medicinal products containing terlipressin: new recommendations
Terlipressin is an active substance that is used, among other things, to treat hepatorenal syndrome, the acute form kidney failure, which occurs in severe and advanced liver disease, improve kidney function. However, medicines containing terlipressin may increase the risk of life-threatening complications respiratory failure highlight.
Like most drugs, the active ingredient terlipressin has various side effects. It is already known that this can lead, among other things, to respiratory diseases. However, there are also indications that drugs containing terlipressin may be associated with a significantly more intense health risk, according to a recent report by the Federal Institute for Medicines and Medical Devices (BfArM).
New risk reduction measures recommended
According to information, on 29 September 2022 the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) adopted new measures for reduction risks associated with the use of medicinal products containing terlipressin.
Die recommendation The PRACs have been forwarded to the Coordinating Group for Mutual Recognition and Decentralized Procedures – Humane (CMDh), which has now unanimously approved and endorsed them with its opinion on 10 November 2022.
These relate to risks such as respiratory failure (severe breathing difficulties which life threatening and sepsis (bacteria and their toxins in the blood that can damage organs) in people with hepatorenal syndrome type 1 (HRS-1, severe kidney problems in people with advanced liver disease).
Use should be avoided in some individuals
New measures now include the inclusion of a warning notice in the product information. This is to clarify that the use of medicinal products containing terlipressin should be avoided in patients with advanced acute exacerbation of chronic liver disease or advanced renal failure.
Patients with respiratory problems should be stabilized with respect to these respiratory problems before taking terlipressin-containing drugs. During and after treatment they should be checked for signs of a symptoms be monitored for respiratory failure and infection.
Frequency of respiratory failure higher than stated in the product information
New referrals are the result of a exam available data according to PRAC. This includes the results of a clinical study on patients with HRS-1.
These suggested that people treated with medicines containing terlipressin were more likely to have it compared to those given a placebo (a dummy treatment). respiratory disorders and dies within 90 days of the first dose.
Although respiratory failure is known side effect drugs containing terlipressin, the rate of respiratory failure in the study was higher (11 percent) than reported in the product information.
Besides, it was Sepsis (“blood poisoning”) was seen in seven percent of the patients treated with terlipressin in the study, but in none of the people who received a placebo.
Based on the new findings, the EMA recommends several measurereduce these risks:
Medicinal products containing terlipressin should be used to treat HRS-1 in people with advanced renal failure and in patients with advanced acute deterioration chronic liver disease should not be used unless considered essential.
patients with Atemproblemen Because of these breathing problems, he should be stabilized before using drugs containing terlipressin.
Before and during therapy monitored for respiratory failure and infection and treated as needed.
Other recommended actions are management the drug as a continuous infusion rather than as a bolus injection (giving the entire dose at once).
As the BfArM explains, terlipressin is a Vasopressin analog. This means it works just like the natural hormone vasopressin. It narrows certain blood vessels in the body, especially those that supply the abdominal organs.
In people with HRS-1, increased blood pressure in the liver due to liver failure causes these blood vessels to dilate, which is a bad thing. blood supply kidneys. By constricting the blood vessels that supply the abdominal organs, terlipressin helps restore blood flow to the kidneys, improving kidney function.
Terlipressin is like solution and as a powder for solution, both for intravenous use. (advertisement)
Author and source information
This text meets the requirements of the medical literature, medical guidelines and current studies and has been reviewed by health professionals.
This article contains general advice only and should not be used for self-diagnosis or treatment. It cannot replace a doctor’s visit.