Remdesivir
The dangerous drug attorneys at the Law Offices of Gregory Krasovsky can provide legal advice and representation to individuals and families considering pursuing a Remdesivir (VEKLURY®) lawsuit.
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[VIDEO] Remdesivir-related product liability, medical malpractice and wrongful death claims.
The Law Offices of Gregory Krasovsky
March 18, 2024
A primer on how we handle Remdesivir (VEKLURY®) related claims for product liability, medical malpractice and wrongful death.
YouTube: https://www.youtube.com/watch?v=SzP0REiKONU
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In order for a plaintiff to secure a maximum settlement in litigation of a Remdesivir claim, regardless of whether in an individual lawsuit or in a class action lawsuit, it is crucial that the law firm representing you have a competent and experienced team of Remdesivir lawyers to guide you through all of the legal hurdles as well as direct you to sufficient funding (litigation funding or legal finance) to cover pharmaceutical litigation costs.
Contact a Remdesivir attorney today to schedule a free consultation and take your first step to obtaining compensation for losses caused by Remdesivir side effects.
Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein.
During the COVID‑19 pandemic, Remdesivir was approved or authorized for emergency use to treat COVID‑19 in numerous countries.
Remdesivir was originally developed to treat hepatitis C, and was subsequently investigated for Ebola virus disease and Marburg virus infections before being studied as a post-infection treatment for COVID‑19.
Although Remdesivir is an effective antiviral, it has some severe side effects that could be the subject of litigation.
Side effects include:
- Allergic reactions
- Increase in liver enzymes
- Severe nausea
- Reduced renal function & fluid build-up in the lungs*
Additionally, Several precautions must be taken by your medical provider before prescribing Remdesivir. If these precautions weren’t taken, then may be eligible to file a medical malpractice lawsuit.
Before taking Remdesivir did your doctor or pharmacist know, ask, or get put on notice of:
- Allergies
- Medical history, particularly, kidney and/or liver disease
- Pregnancy or breast-feeding
If you or a loved one has been seriously injured as a result of taking Remdesivir, you might be eligible for compensation, which a Remdesivir lawsuit can help you secure.
Contact one of our dangerous drug lawyers today to schedule a free and confidential case consultation.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VEKLURY safely and effectively. See full prescribing information for VEKLURY.
VEKLURY® (remdesivir) for injection, for intravenous use VEKLURY® (remdesivir) injection, for intravenous use
Initial U.S. Approval: 2020
Revised: 04/2022
WARNINGS AND PRECAUTIONS
• Hypersensitivity including infusion-related and anaphylactic reactions: Hypersensitivity reactions have been observed during and following administration of VEKLURY. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent signs and symptoms of hypersensitivity. Monitor patients during infusion and observe patients for at least one
hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. (5.1)
• Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and have also been reported in patients with COVID-19 who received VEKLURY. Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate. Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation. (5.2)
• Risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate: Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments demonstrating a potential antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased. (6.1)
5. WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Including Infusion-related and Anaphylactic Reactions
Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of VEKLURY; most occurred within one hour. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. The use of VEKLURY is contraindicated in patients with known hypersensitivity to VEKLURY or any components of the product [see Contraindications (4)].
5.2 Increased Risk of Transaminase Elevations
Transaminase elevations have been observed in healthy volunteers who received 200 mg of VEKLURY followed by 100 mg doses for up to 10 days; the transaminase elevations were mild
(Grade 1) to moderate (Grade 2) in severity and resolved upon discontinuation of
VEKLURY. Transaminase elevations have also been reported in patients with COVID-19 who received VEKLURY [see Adverse Reactions (6.1)]. Because transaminase elevations have been reported as a clinical feature of COVID-19, and the incidence was similar in patients receiving placebo versus VEKLURY in clinical trials of VEKLURY, discerning the contribution of VEKLURY to transaminase elevations in patients with COVID-19 can be challenging.
Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate [see Dosage and Administration (2.1) and Use in Specific Populations (8.7)].
• Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal.
• Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
• Hypersensitivity Including Infusion-related and Anaphylactic Reactions [see Warnings and Precautions (5.1)]
• Increased Risk of Transaminase Elevations [see Warnings and Precautions (5.2)]
8 USE IN SPECIFIC POPULATIONS
8.6 Renal Impairment
The pharmacokinetics of VEKLURY have not been evaluated in patients with renal impairment. Patients with eGFR greater than or equal to 30 mL per minute have received VEKLURY for treatment of COVID-19 with no dose adjustment of VEKLURY [see Clinical Studies (14)].
All patients must have an eGFR determined before starting VEKLURY and while receiving VEKLURY as clinically appropriate. Because the excipient betadex sulfobutyl ether sodium is renally cleared and accumulates in patients with decreased renal function, administration of drugs formulated with betadex sulfobutyl ether sodium (such as VEKLURY) is not recommended in patients with eGFR less than 30 mL per minute [see Dosage and Administration (2.2, 2.4)].
8.7 Hepatic Impairment
The pharmacokinetics of VEKLURY have not been evaluated in patients with hepatic impairment.
Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate [see Dosage and Administration (2.2) and Warnings and Precautions (5.2)].
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf
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Important Safety Information - BY GILEAD Sciences, Inc.
Contraindication
- VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.
Warnings and precautions
- Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate.
Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering.
Slower infusion rates (maximum infusion time of up to 120 minutes) can potentially prevent these reactions.
If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19.
Perform hepatic laboratory testing in all patients (see Dosage and administration).
Consider discontinuing VEKLURY if ALT levels increase to >10x ULN.
Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the antiviral activity of VEKLURY.
Adverse reactions
- The most common adverse reaction (≥5% all grades) was nausea.
- The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.
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Development timeline for Veklury (Remdesivir)
https://www.drugs.com/history/veklury.html
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Veklury
Warnings
Before taking this medicine
You should not be treated with Veklury if you are allergic to remdesivir.
To make sure Veklury is safe for you, tell your doctor if you have ever had:
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liver disease; or
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kidney disease.
Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.
Veklury side effects
Get emergency medical help if you have signs of an allergic reaction to Veklury: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during or after the injection. Tell your caregiver right away if you have:
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severe headache, pounding in your neck or ears;
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fast, slow, or pounding heartbeats;
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wheezing, trouble breathing;
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swelling in your face;
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fever, chills, or shivering;
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itching, sweating; or
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a light-headed feeling, like you might pass out;
Common Veklury side effects may include include:
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nausea; or
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abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
https://www.drugs.com/veklury.html
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Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database
- PMID: 33340409
- DOI: 10.1002/cpt.2145
Erratum in
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Corrigendum: Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database.Clin Pharmacol Ther. 2022 Jun;111(6):1343. doi: 10.1002/cpt.2587. Epub 2022 Apr 6. PMID: 35385584 No abstract available.
Abstract
Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19).
Its benefit-risk ratio is still being explored because data in the field are rather scant.
A decrease of the creatinine clearance associated with remdesivir has been inconstantly reported in clinical trials with unclear relevance.
Despite these uncertainties, we searched for a potential signal of acute renal failure (ARF) in pharmacovigilance postmarketing data.
An analysis of the international pharmacovigilance postmarketing databases (VigiBase) of the World Health Organization (WHO) was performed, using two disproportionality methods.
Reporting odds ratio (ROR) compared the number of ARF cases reported with remdesivir, with those reported with other drugs prescribed in comparable situations of COVID-19 (hydroxychloroquine, tocilizumab, and lopinavir/ritonavir).
The combination of the terms "acute renal failure" and "remdesivir" yielded a statistically significant disproportionality signal with 138 observed cases instead of the 9 expected.
ROR of ARF with remdesivir was 20-fold (20.3; confidence interval 0.95 [15.7-26.3], P < 0.0001]) that of comparative drugs.
Based on ARF cases reported in VigiBase, and despite the caveats inherent to COVID-19 circumstances, we detected a statistically significant pharmacovigilance signal of nephrotoxicity associated with remdesivir, deserving a thorough qualitative assessment of all available data.
Meanwhile, as recommended in its Summary of Product Characteristics, assessment of patients with COVID-19 renal function should prevail before and during treatment with remdesivir in COVID-19.
https://pubmed.ncbi.nlm.nih.gov/33340409/
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Remdesivir (EUA) Vial?
The following conditions are contraindicated with this drug.
Check with your physician if you have any of the following:
Conditions:
sinus bradycardia
abnormal liver function tests
chronic kidney disease stage 4 (severe)
chronic kidney disease stage 5 (failure)
https://www.webmd.com/drugs/2/drug-179015/remdesivir-intravenous/details/list-contraindications
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Renal and liver injury following the treatment of COVID-19 by remdesivir
, Elham Jahantabi 2, Behzad Lotfi 3, Mehdi Forouzesh 4, Rohollah Valizadeh 5 , Saman Farshid 6* 1 Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
2 Urology Department, Tabriz University of Medical Sciences, Tabriz, Iran
3 Department of Urology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
4 Legal Medicine Research Center, Legal Medicine Organization, Tehran, Iran
5 Student Research Committee, Department of Epidemiology, School of Public Health, Tehran, Iran University of Medical Sciences, Tehran, Iran
6 Department of Urology and Nephrology, Urmia University of Medical Sciences, Urmia, Iran
Abstract
Remdesivir initially was intravenously administrated to treat the Ebola disease however right now it has been administered to treat COVID-19 in some countries.Implication for health policy/practice/research/medical education:
In the patients taking remdesivir, liver and kidney function tests should be monitored daily, and remdesivir should be held in patients with increased liver enzymes or kidney function impairment.
https://nephropathol.com/Article/jnp-17106
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