Side Effects of Entresto May Drop Blood Pressure Too Low For Many Hypertension Patients: Report
An independent analysis of adverse event reports submitted to federal drug regulators suggests that the hypertension medication Entresto, which was just introduced two years ago, may actually be causing dangerously low levels of blood pressure for many users.
In the latest QuarterWatch report (PDF) issued by the Institute for Safe Medication Practices, the potential side effects of Entresto are highlighted, after the group identified at least 6.770 adverse event reports submitted to the FDA during a one-year period.
While the majority of cases involving problems with Entresto (61%) did not have medically serious consequences, the group indicates that the adverse event reports include at least 681 deaths and 1,684 reports of hypotension (low blood pressure) related events.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.
Learn MoreEntresto is a combination of the drugs sacubitril and valsartan, which is the active ingredient in Diovan. It was introduced by Novartis after it was approved by the FDA in July 2015, based on the evidence of only a single clinical trial, which involving 8,442 patients.
“As a drug combination product, FDA reviewers noted, the single clinical trial did not provide the required evidence that sacubitril in fact added any benefit to the already-proven valsartan,” the ISMP notes. “This requirement was waived.”
ISMP researchers found that, over the 12 month period ending in March 2017, Entresto was linked to more cases of hypotension than any other heart drug on the market during that time. In addition to the 1,684 hypotension reports, the FDA’s adverse event reporting system (FAERS) also received 317 reports of kidney failure and impairment, 152 reports of angioedema, and 87 reports of hyperkalemia.
The independent report notes that FDA reviewers raised concerns about the drug before it was approved, warning that the clinical trial results involved carefully selected patients that led to an underestimation of the risk of hypotension in what would likely be normal use. The ISMP warns that its likely that one out of every four patients who take the drug will experience a hypotension-related event.
The clinical study on which the drug’s approval was based indicated that 14% of treated patients would experience symptomatic hypotension. However, the study’s data indicated that 17.6% would experience some kind of hypotension-related event. Once FDA reviewers looked at all the symptoms the clinical trial participants experienced that were related to hypotension, they raised the estimate to 24.4%. The ISMP’s own look at the data increased that to nearly 30%.
“Hypotension-or low blood pressure-means these patients are getting too much of what otherwise might be a good thing,” the ISMP researchers stated. “How frequently this occurred provided a textbook example of how adverse effects of drugs can be understated with narrow event definitions that do not capture all the likely cases.”
Get more articles like this sent directly to your inbox.
"*" indicates required fields
11 Comments
JohnDecember 4, 2023 at 1:35 pm
My cardiologist after saying my heart only pumps out 70% of the blood that it takes in put me on a combination of Entresto 24-26MG & Lasik. After additional bloodwork one week later, he increased the dosage to.49-51MG within days. I started feeling lightheaded and faint and had low blood pressure one day I passed out in public which ended me up in the hospital. He put me back on the lower dosage [Show More]My cardiologist after saying my heart only pumps out 70% of the blood that it takes in put me on a combination of Entresto 24-26MG & Lasik. After additional bloodwork one week later, he increased the dosage to.49-51MG within days. I started feeling lightheaded and faint and had low blood pressure one day I passed out in public which ended me up in the hospital. He put me back on the lower dosage however, I am still having problems with low blood pressure 80/60 my body is telling me not to take this medication. It’s only been a day although my blood pressure still feels a little low it’s not as bad I only hope that the effect of low blood pressure subsides, in that I have never had low blood pressure in my life until I started this medication.
PhyllisAugust 12, 2022 at 1:39 pm
My sister Betty died because of this poison drug. She was doing go until her doctor( I am sure got kick back for prescribe this ) my sister was taking care of. Her bed ridden husband to me have having to take care of both. She got to were she could not get up and around on her own after taking this drug. Her kidneys starting shutting down heart rate dropped and she died within a few month. M[Show More]My sister Betty died because of this poison drug. She was doing go until her doctor( I am sure got kick back for prescribe this ) my sister was taking care of. Her bed ridden husband to me have having to take care of both. She got to were she could not get up and around on her own after taking this drug. Her kidneys starting shutting down heart rate dropped and she died within a few month. My promise to her was she was not going to died in vain I am and will find some one that will fight this company. I spend a lot of money taking care of her and they need to have to pay for your problem and you loved ones death. I will fight as long as I live. I am think I owe this to her. If anyone knows any lawyers that will go against this company maybe they will contact us.
JacquelineAugust 8, 2022 at 3:11 pm
I suffered complete renal and liver failure after taking Entresto and Aldactone for 6 weeks. Was in septic shock, intubated in ICU for 3 weeks. Followed by another week in the hospital and 5 weeks of rehab. I still cannot walk.
JudithApril 8, 2022 at 5:44 pm
I recently started taking the lowest dose of Entresto. After a few days I started feeling tired and dizzy. I checked my BP and it was very low. I felt lucky that I didn't go into shock. Plus, it's irritating that I wasted so much money on a 3 month supply.
BrendaMarch 14, 2022 at 1:45 pm
My husband died three days after starting this medicine. I firmly believe the medicine was the cause. Please do not try this medicine without researching it thoroughly.
HannahNovember 11, 2021 at 6:03 pm
My mother was prescriber Entrestro back in early 2020. She had blood labs, doctor visits and they kept her on this medication even though she reported she would get dizzy or feel faint. They thought it was may be something else causing the issues since she has heart disease and diabetes. Fast forward to October 2021, she had a doctor's appointment and they noticed her kidneys are now operating at [Show More]My mother was prescriber Entrestro back in early 2020. She had blood labs, doctor visits and they kept her on this medication even though she reported she would get dizzy or feel faint. They thought it was may be something else causing the issues since she has heart disease and diabetes. Fast forward to October 2021, she had a doctor's appointment and they noticed her kidneys are now operating at 15% and might need dialysis due to this drug. They took her off the medication abruptly and she suffered a major cardiac event. The hospital said they'd "investigate" but there have been zero updates regarding this fiasco. She had to be admitted into the ICU for multiple days, if my father had not heard her barely breathing in the middle of the night and rushed her to the ER she would've passed. We are small family and this caused waves of panic, chaos and trauma within our small brood. Each child has been traveling to Iowa where my parents are located to ensure they have the support and help they need until home nursing care is setup. My mom was released early from the nursing care facility she was transferred to for rehab due to a Covid outbreak. It has caused devastating ripples in everyone's life this horrible prescription and we are worried it will hurt more people in the future. Please avoid this drug at all costs.
KristieNovember 6, 2021 at 6:32 pm
I was put on entresto and shortly after I started having issues. Kidney infection, and unable to urinate for three days. I stopped taking the entresto and was able to urinate the day after stopping the drug. I had blood work done and my kidney function dropped from a 80% to 40%.
DouglasOctober 24, 2021 at 2:42 pm
I have been put on Entrust and it lowers my blood pressure too low I monitor my BP day & day time I do not take it if my blood pressure is low. Wondering if I should keep taking such a drug.
RonaldOctober 10, 2021 at 8:13 pm
The Cardio unit started me on Entresto i have had nothing but problems near fainting dizziness very low blood pressure 59 over44 i have stopped before its to late devil drug thank Christ on it for less then two weeks just waiting for side effects to go away compleaty.
ronaldJuly 3, 2021 at 7:13 pm
I recently had a clip surgery on my mitro-valve. I am prescribed to take entresto and playvix. My blood pressure dropped to 90 over 50. As a result felt very dizzy, weak and tired. Reported to my doctor, no answer and also taking 20 mg. of furisomide 2 X a day. Undiagnosed at this time. recently
williamMay 9, 2021 at 5:39 pm
I had been taken Entresto since May 2020 and most recently, blacked out, fell and broke my left femur bone. After 3-1/2 months, I am still learning to walk again. It is believed that Entresto, with the side effects of getting dizzy and fainting, was the main reason that I blacked out.. My cardiologist also agrees that Entresto was the main reason for my injury.