Introduction

Veterinarians and pet owners rely on innovative treatments to improve the quality of life for animals suffering from chronic conditions. One such advancement is Bedinvetmab (bedinvetmab injection), a monoclonal antibody approved by the FDA’s Centre for Veterinary Medicine (CVM) in May 2023 for the management of osteoarthritis-related pain in dogs. However, like any medication, post-marketing surveillance has revealed potential risks that warrant attention.

The FDA has completed an evaluation of adverse events reported in dogs treated with Bedinvetmab, identifying neurological effects such as ataxia, seizures, paresis, recumbency, and urinary incontinence. In some instances, these adverse events led to death or euthanasia. This information has been made publicly available through the FDA’s CVM FOIA Electronic Reading Room to ensure veterinarians remain informed about emerging safety concerns.

This blog outlines what veterinarians need to know about Bedinvetmab safety profile, the importance of adverse event reporting, and the role of post-marketing surveillance in safeguarding animal health.

What Is Bedinvetmab?

Bedinvetmabis is a monoclonal antibody (mAb) therapy designed to target and neutralize nerve growth factor (NGF), a key mediator of pain in osteoarthritis. Unlike nonsteroidal anti-inflammatory drugs (NSAIDs), which may pose risks to liver and kidney function, monoclonal antibodies offer an alternative treatment approach by reducing inflammation and pain at the molecular level.

Key Features of Bedinvetmab:

• Approved Use: Management of pain associated with osteoarthritis in dogs.
• Mechanism of Action: Blocks NGF, thereby reducing pain perception.
• Administration: Subcutaneous injection once a month, with the dosage tailored to the dog's weight.
• Pre-Approval Studies: Clinical trials reviewed by the FDA demonstrated Bedinvetmab efficacy in alleviating pain and improving mobility in dogs with osteoarthritis.

Understanding the Adverse Events

Despite its benefits, post-marketing reports have highlighted neurological adverse events in some dogs receiving Bedinvetmab. These include:

• Ataxia – Loss of coordination, affecting movement and balance.
• Seizures – Convulsions or loss of consciousness.
• Paresis – Partial paralysis or muscle weakness.
• Recumbency – Inability to rise or prolonged lying down.
• Urinary Incontinence – Loss of bladder control.

In severe cases, these adverse events have resulted in euthanasia or death, underscoring the need for careful monitoring and prompt reporting of any unusual symptoms following administration.

Adverse Event Reporting and Monitoring

Veterinarians play a critical role in ensuring drug safety by reporting adverse events associated with Bedinvetmab. These reports provide valuable data that help regulatory authorities assess risks and update safety guidelines if necessary.

How Veterinarians Can Report Adverse Events:

1. FDA’s Veterinary Adverse Event Reporting System (VAERS) – Directly report suspected adverse reactions via the FDA’s online portal.
2. Reporting to the Drug Sponsor – Manufacturers are required to collect and evaluate safety data for their products.
3. Providing Detailed Case Information – Reports should include:
   • Dog’s medical history and concurrent medications.
   • Number of Bedinvetmab doses administered.
   • Onset, duration, and severity of symptoms.
   • Lot number of the administered drug vial.

FDA’s Safety Monitoring Methods

The FDA’s Center for Veterinary Medicine (CVM) employs multiple safety monitoring strategies to track and assess reported adverse events:

1. Adverse Event Reporting Systems – VAERS and FAERS (FDA Adverse Event Reporting System) collect and analyse adverse event data.
2. Signal Detection and Data Analysis – AI-driven data mining techniques help identify potential safety signals based on reported cases.
3. Periodic Safety Update Reports (PSURs) – Manufacturers submit routine safety summaries to regulatory agencies.
4. Post-Marketing Surveillance & Phase IV Studies – Long-term studies assess safety in real-world clinical settings.

The FDA continues to update its safety findings on Bedinvetmab, making them accessible through the CVM FOIA Electronic Reading Room to keep veterinarians informed about emerging risks.

Maven Safety Assessment Services: Your Partner in Drug Safety

Pharmaceutical and veterinary drug manufacturers face significant challenges in post-market safety monitoring and regulatory compliance. Maven’s Safety Assessment services provide end-to-end solutions to help companies identify risks, comply with regulations, and enhance product safety.

Maven specializes in

  Adverse Event Monitoring & Analysis – Identifying trends and mitigating risks before they escalate.

 Regulatory Compliance Support – Ensuring adherence to FDA, EMA, and global veterinary drug safety regulations.

 Post-Marketing Surveillance & Risk Management – Implementing robust strategies for long-term product safety.

 Signal Detection & Data Analytics – Leveraging AI-driven insights for proactive risk assessment.

At Maven, we work with pharmaceutical and veterinary companies to develop comprehensive risk management plans, ensuring products meet the highest safety and efficacy standards. Our expertise extends across human and veterinary medicines, helping businesses navigate regulatory complexities with confidence.

Conclusion

Ensuring drug safety doesn’t stop at approval—continuous monitoring of adverse events is critical for protecting animal health and maintaining regulatory compliance. Veterinarians play an essential role in reporting adverse events, contributing to a broader understanding of a drug’s long-term safety profile.

Key Takeaways:

• Bedinvetmab is a monoclonal antibody therapy for managing osteoarthritis pain in dogs.
• The FDA has identified neurological adverse events such as ataxia, seizures, paresis, recumbency, and urinary incontinence.
• Veterinarians should promptly report adverse reactions to the FDA or the manufacturer to enhance drug safety monitoring.
• The FDA continuously updates safety findings in the CVM FOIA Electronic Reading Room.
• Maven’s Safety Assessment services provide expert support in risk assessment, regulatory compliance, and post-marketing surveillance.

By staying informed and proactive, veterinarians and drug manufacturers can work together to ensure the highest safety standards for animal healthcare products. Partner with Maven today to safeguard your veterinary and pharmaceutical products. Contact us to discuss how our safety solutions can support your regulatory and risk management needs.