Petition to:

🇬🇧Veterinary Medicines Directorate (VMD), postmaster@vmd.gov.uk

🇦🇺Australian Pesticides and Veterinary Medicines Authority (APVMA), enquiries@apvma.gov.au

Recall Solensia and Librela from the UK and Australian markets

We, the undersigned, are pet owners, pet rescuers, animal lovers, and advocates for the health and safety of animals. With great urgency and concern, we respectfully call upon the Veterinary Medicines Directorate (VMD) andAustralian Pesticides and Veterinary Medicines Authority (APVMA) to take immediate action to suspend and recall the veterinary drugs Solensia (frunevetmab) and Librela (bedinvetmab) from the UK and Australian markets. 

 

1. The Risks of NGF Inhibition

Nerve Growth Factor (NGF) is essential not only for pain regulation but also for nerve function, immune health, and cell survival. Drugs targeting NGF—like Solensia and Librela—have been associated with severe adverse effects, including (but not limited to):

• Lethargy, inappetence, and severe dehydration
• Immune system suppression
• Neurological damage (e.g., tremors, seizures, vision loss, hear loss, paralysis)
• Multi-organ failure (kidneys, pancreas, liver)
• Increased susceptibility to cancer
• Sudden, unexplained deaths

 

2. Failure to Demonstrate Net Benefit

While Solensia and Librela aim to alleviate osteoarthritis pain, the risk of life-threatening adverse events outweighs the potential benefits for many animals.

 

3. Solensia and Librela Were Insufficiently Tested Before Approval

Both drugs belong to a new class of monoclonal antibody treatments for osteoarthritis in pets. However, their long-term effects remain inadequately studied, leaving unknown risks for chronic use, particularly in senior and vulnerable animals. 

Solensia was tested for only 112 days in a pivotal trial conducted on just 182 cats, a grossly inadequate duration and sample size to assess long-term safety for a drug intended for lifelong use. Post-market reports have highlighted numerous adverse events, including neurological disorders, organ failure, and fatalities, though these have often been dismissed by Zoetis and veterinarians as unrelated to the drug.

Similarly, Librela, intended for lifelong use in dogs, was tested for only 84 days in its pivotal field study, involving just 272 dogs. Like Solensia, Librela’s testing was far too short and limited to identify long-term risks. Subsequent reports have revealed adverse effects such as neurological issues, behavioral changes, and even fatalities in some cases, and also have been dismissed by the veterinary community as not related to the drug. 

 

4. Insufficient Awareness and Reporting

Many pet owners have reported that veterinarians administering these treatments did not provide sufficient information about potential side effects or risks. Furthermore, it is unclear whether the globally rising adverse events are being adequately reported to regulatory bodies, leaving gaps in pharmacovigilance data.

5. Lessons from Raylumis (Tanezumab) 

The human NGF-inhibitor drug Raylumis (Tanezumab), developed by Pfizer and Eli Lilly to treat osteoarthritis in humans, provides a cautionary tale. Despite its initial promise, Tanezumab’s approval was ultimately rejected by regulatory authorities due to severe and irreversible side effects, including:

• Rapidly Progressive Osteoarthritis (RPOA): This condition led to the rapid destruction of healthy joints in patients, requiring joint replacements in some cases.
• Nerve and joint damage: These side effects outweighed any benefits of pain relief.

The rejection of Tanezumab underscores the dangers of NGF inhibition as a mechanism, and raises serious questions about the safety of similar drugs in veterinary use.

6. Lack of Adequate Post-Market Surveillance

With growing global reports of adverse reactions to Solensia and Librela, there is an urgent need for greater transparency and stricter post-market monitoring. Current systems are insufficient to protect the health and safety of animals receiving these drugs.

 

7. Call for Safer Standards 

We urge the VMD and APVMA to:

 1. Immediate Recall of Solensia and Librela

Suspend the authorization of both drugs until an independent, comprehensive review of their safety profiles is conducted.

 2. Transparent Investigation

Publish detailed findings regarding reported adverse events, including specific case outcomes, risk factors, and mortality rates.

 3. Adopt stricter approval criteria for NGF-inhibitor drugs, requiring larger and longer trials to assess risks thoroughly.

 4. Improved Safety Warnings

If the products remain on the market, mandate stronger safety warnings on all marketing materials and product packaging to ensure veterinarians and pet owners are fully informed of potential risks.

 

Conclusion

Solensia and Librela were introduced with the promise of improving the lives of pets suffering from osteoarthritis. However, the rising number of serious adverse reactions shows that these drugs pose significant risks that must be addressed immediately.

As advocates for animal welfare, we urge the VMD and APVMA to take swift and decisive action to protect our pets and restore confidence in veterinary medicine.

Sincerely,

Jessica Mikaelson, LFPCSA (UK)

 and Jackie Ralph, Solensia: Adverse Effects Forum & Information (AU)

LFPCSA.CO.UK - Solensia Information ​

Solensia K*lled my Cat… Solensia - Class Action | LFPCSA​

Solensia: Adverse Effects Forum & Information​

help@lfpcsa.co.uk 

 

Please sign this petition to demand accountability and safety for our beloved animals.