Remdesivir: Stroke Risk And Complications Explained

Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein and was approved for emergency use to treat COVID-19 in several countries during the pandemic. While the drug has been found to be effective in treating the virus, it has also been linked to certain side effects, including nausea, abdominal pain, diarrhoea, and increased liver enzymes. In December 2021, tens of thousands of vials of remdesivir were recalled due to glass contamination, which could potentially lead to adverse health effects such as stroke or even death.

Remdesivir's side effects

Remdesivir, sold under the brand name Veklury, is an antiviral medication that was used to treat COVID-19. It is administered via injection into a vein. While the drug is generally well-tolerated, it has been associated with several side effects, some of which can be serious. Here is a detailed overview of the side effects of Remdesivir:

Common Side Effects:

• Nausea: This is one of the most frequently reported side effects of Remdesivir. It is often mild and can be managed with dietary adjustments.
• Elevated Liver Enzymes: Remdesivir can cause mild elevations in liver enzyme (protein) levels, which usually resolve on their own. However, close monitoring of liver health is recommended during treatment.
• Infusion Reactions: These may include pain or swelling at the injection site, changes in blood pressure, and changes in heart rate. These reactions typically occur within 1 hour of the infusion.

Less Common Side Effects:

• Difficulty swallowing
• Light-colored stools
• Puffiness or swelling of the eyelids, face, lips, or tongue
• Stomach pain
• Unusual tiredness or weakness

Rare but Serious Side Effects:

• Hypersensitivity Reactions: These can include allergic reactions and severe infusion reactions, such as anaphylaxis and angioedema (severe facial swelling).
• Liver Injury: In rare cases, Remdesivir can lead to liver injury or intense liver inflammation, especially in critically ill patients.
• Kidney Injury: Remdesivir has the potential to cause kidney issues, and lab tests are recommended before administering the drug to ensure kidney health.
• Generalized Seizures: There have been rare reports of Remdesivir being associated with generalized seizures, which can affect all parts of the brain.
• Blood Clotting Effects: Remdesivir can delay the formation of blood clots by elevating prothrombin time, theoretically increasing the risk of bleeding-related complications.

Other Reported Side Effects:

• Gastrointestinal distress
• Electrocardiogram abnormalities
• Respiratory failure
• Low albumin, low potassium, low red blood cell count, and low thrombocyte count
• Increased blood glucose and uric acid levels
• Headache

It is important to note that the side effects of Remdesivir can vary from person to person, and not all side effects may be visually noticeable. Therefore, it is crucial to monitor patients closely and report any concerning or persistent symptoms to a healthcare provider.

Glass contamination in Remdesivir

Remdesivir, sold under the brand name Veklury, is an antiviral medication used to treat COVID-19. In September 2024, its manufacturer, Gilead Sciences, issued a voluntary recall of one lot of the drug due to glass particle contamination. The recall affected lot #47035CFA, which was distributed across the United States between July 16 and August 7, 2024.

The presence of glass particles in injectable medication poses significant health risks. If injected, the glass particles could cause local irritation or swelling. Should they enter the bloodstream, they can travel to vital organs and block blood vessels in the heart, lungs, or brain, potentially leading to a stroke or even death.

Gilead Sciences initiated the recall after receiving a customer complaint, which prompted an internal investigation that confirmed the contamination. The company instructed healthcare facilities and distributors to stop using the affected lot and facilitated the return of the contaminated vials.

While there have been no reported adverse events linked to the recall as of yet, the potential health consequences of glass particulate contamination are severe. Consumers with concerns or adverse reactions are advised to contact their healthcare providers, and any adverse reactions can be reported to the FDA through the MedWatch program.

Remdesivir's impact on blood pressure

Remdesivir is an antiviral medication developed by Gilead Sciences, which was approved for the treatment of COVID-19 in numerous countries. It is administered via injection into a vein.

Remdesivir has been associated with a range of side effects, including nausea, liver inflammation, and infusion-related reactions such as low blood pressure, nausea, vomiting, sweating, and shivering.

Regarding its impact on blood pressure, remdesivir has been linked to hypotension, or low blood pressure. This is listed as a possible side effect in several sources. Additionally, according to a study by Dr. William Brady and colleagues, remdesivir should be administered with caution to patients with COVID-19 as it could lead to abnormal heart rhythms (arrhythmias) and low blood pressure.

The study also highlights the importance of doctors remaining alert to the range of potential health ramifications of COVID-19, including its impact on the cardiovascular system. Remdesivir's potential impact on blood pressure is, therefore, an important consideration for healthcare providers.

It is worth noting that the US Food and Drug Administration (FDA) considers remdesivir to be a first-in-class medication, and it has played a significant role in the treatment of COVID-19 patients worldwide. However, as with any medication, it is essential to be aware of its potential side effects and carefully monitor patients during treatment.

Remdesivir's effect on the liver

Remdesivir is an antiviral nucleotide analogue used to treat severe COVID-19. It is administered intravenously for 3 to 10 days. It is a prodrug that is converted by esterases and a phosphoamidase into its active metabolite, GS-441524 triphosphate, which inhibits viral RNA polymerase.

Remdesivir has been associated with a range of side effects, including mild-to-moderate elevations in serum aminotransferase levels, nausea, vomiting, headache, fatigue, renal dysfunction, rash, and rare instances of hypersensitivity reactions, acute renal dysfunction, and liver injury. While liver injury is uncommon, it is important to monitor liver tests before and during treatment with remdesivir, particularly in patients with pre-existing liver disease.

In human volunteer studies, remdesivir therapy for 7 to 14 days resulted in minor serum aminotransferase elevations (less than 5 times ULN) without other evidence of hepatic injury. In controlled trials of remdesivir in patients hospitalized with COVID-19, rates of serum ALT elevations were similar to or lower than those observed in placebo groups. However, in uncontrolled studies and case series, between 10% and 50% of patients treated with remdesivir developed transient, mild-to-moderate serum ALT and AST elevations within 1 to 5 days of starting therapy. Elevations above 5 times ULN were reported in up to 9% of patients in several clinical trials, but these abnormalities resolved with discontinuation and were not associated with clinically apparent injury.

With the widespread use of remdesivir for COVID-19, rare instances of marked ALT elevations with jaundice have been reported, particularly in critically ill patients with multi-organ failure or sepsis, or those who received other potentially hepatotoxic agents. The SARS-CoV-2 virus can also infect the liver, and its receptor, angiotensin-converting enzyme 2 (ACE2), is found on the surface of hepatocytes. Therefore, it is challenging to attribute liver injury solely to remdesivir in patients with COVID-19.

The liver metabolizes remdesivir, and it is a substrate for CYP 3A4 and the hepatocyte transporters p-glycoprotein and OATP1B1. As a result, remdesivir may be susceptible to drug-drug interactions with agents that inhibit or induce these enzymes and transporters. For example, the marked elevations in serum aminotransferase levels observed in one patient treated with remdesivir and amiodarone may have been due to amiodarone altering the pharmacokinetics of remdesivir by inhibiting p-glycoprotein.

In summary, while remdesivir has been associated with transient and reversible elevations in liver enzymes, clinically apparent liver injury is rare. However, careful monitoring of liver tests is recommended before and during treatment, particularly in patients with pre-existing liver disease or those receiving other potentially hepatotoxic agents.

Remdesivir's use in COVID-19 treatment

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.

Remdesivir was originally developed to treat hepatitis C and was subsequently investigated for Ebola and Marburg virus infections before being studied as a post-infection treatment for COVID-19. In October 2020, the US Food and Drug Administration (FDA) approved the drug for the treatment of COVID-19 in people aged 12 and above. In April 2022, the FDA expanded the approval of remdesivir to include people 28 days of age and older weighing at least 3 kilograms. The drug is now the first approved treatment for COVID-19 in children under 12 years of age.

Remdesivir is intended to allow intracellular delivery of GS-441524 monophosphate and subsequent biotransformation into GS-441524 triphosphate, a ribonucleotide analogue inhibitor of viral RNA polymerase. It is a protide (prodrug of nucleotide) able to diffuse into cells, where it is converted to GS-441524 monophosphate. This, in turn, is further phosphorylated to its active metabolite triphosphate. This active metabolite, an adenosine nucleoside triphosphate analog, interferes with the action of viral RNA-dependent RNA polymerase and evades proofreading by viral exoribonuclease, causing a decrease in viral RNA production.

In November 2020, the FDA issued an emergency use authorization (EUA) for the combination of baricitinib with remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized people aged two and above requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In January 2022, a study indicated that non-hospitalized people at high risk for COVID-19 progression had an 87% lower risk of hospitalization or death after a 3-day course of intravenous remdesivir.

The most common side effect in healthy volunteers is raised blood levels of liver enzymes. The most common side effect in people with COVID-19 is nausea. Other side effects may include liver inflammation, gastrointestinal distress, respiratory failure, and infusion-related reactions with nausea, low blood pressure, sweating, or shivering.

In December 2021, tens of thousands of vials of remdesivir were recalled due to glass contamination, which was warned could lead to adverse health effects such as stroke or even death.

Frequently asked questions