GEORGIA — The FDA is alerting veterinarians about reports of health problems in dogs, including hundreds of deaths, tied to a drug for arthritis pain, according to our sister station in Atlanta WSB-2 TV.
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The FDA reached out to WSB-2 investigative reporter Sophia Choi about the efforts after an investigation in November highlighted pet parents in Georgia who say vets never warned them about the side effects from Librela.
The families said that they thought they were helping their dogs.
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Instead, they’re left wondering how their pets ended up hurt or dead, after getting a shot that was supposed to give them new life.
The FDA is now alerting veterinarians about Librela saying “The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia. In some cases, death.”
Zoetis, the maker of Librela, told Channel 2 Action News they are “collaborating with the FDA to help contextualize the data.”
“Zoetis is in discussions with the FDA on label updates.”
The company says that it has distributed 27 million doses of the drug around the world and adverse effects are rare, saying “We remain confident in the safety and effectiveness of Librela,” and “We are deeply committed to listening to – and working with – veterinarians and pet owners.”
The FDA approved Librela for use after the maker Zoetis conducted a study of 272 dogs in the United States, and another 281 dogs in Europe.
“Not a very large population to identify a rare event like a death,” said Josh Sharlin, an FDA reviewer turned expert witness.
Sharlin said the government agency only looks at efficacy not safety when approving products, but the FDA disputes that claim.
They say, “FDA’s approval means the drug is safe and effective when it is used according to the label. FDA’s approval also ensures that the drug’s strength, quality, and purity are consistent from batch to batch and that the drug’s labeling is truthful, complete, and not misleading.”
“That’s why post-approval safety reporting is so important because the safety profile of a product is going to be unknown,” Sharlin said.
WSB-2 learned the FDA received at least 825 reports of dog deaths linked to Librela between May 2023 and June 2024.
“The deaths. I mean … you don’t get any more dramatic than that,” Sharlin said.
The FDA told WSB-2 that they are “currently reviewing and assessing adverse event reports in dogs” and “widespread use of a drug product in a large number of patients may uncover adverse events.”
Librela lists side effects including urinary tract infection, anorexia, and lameness – but not death.
Zoetis said, “We gather as much relevant information as possible when potential adverse events are reported to us. We do this so we can ensure the ongoing safety of our products and report these events to the appropriate regulatory agency.”
A lot of money is at stake with Zoetis predicting Librela and a version for cats bringing in more than $1 billion in three to five years.
WSB-2 spoke to multiple pet parents who say they understand this drug helps a lot of other dogs, but they want Librela pulled and studied more to see why some dogs are so devastatingly affected.
FULL STATEMENTS FROM FDA:
FDA notifies veterinarians about adverse events reported for Librela
Dear Veterinarian,
The U.S. Food and Drug Administration’s Center for Veterinary Medicine has completed an evaluation of adverse events reported in dogs of various ages treated with Librela (bedinvetmab injection). The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia. In some cases, death (including euthanasia) was reported as an outcome of these adverse events. The FDA is making available reports containing summaries of clinical signs reported for Librela in the CVM FOIA Electronic Reading Room.
Drug Information
The FDA approved Librela, a monoclonal antibody drug used for the control of pain associated with osteoarthritis in dogs, on May 5, 2023, and it was introduced to the marketplace later that year. Prior to approval, the FDA reviewed available studies and other data on Librela and determined Librela to be safe and effective for its intended use for control of pain associated with osteoarthritis in dogs. Librela is dosed by weight and labeled for subcutaneous injection once a month.
What should a veterinarian do if a patient treated with Librela has an adverse event?
If a dog under your care experiences an adverse event while receiving Librela, the FDA encourages you to report it to Zoetis, the drug sponsor, at 1-888‑963-8471. Drug sponsors are required to submit reports of adverse drug events to FDA. If you prefer to report directly to FDA, please see www.fda.gov/reportanimalae.
When reporting adverse events to the FDA and/or Zoetis, please include, if available, a full medical history, how many times the dog has received Librela, and the lot number on the vial used.
Where can veterinarians get more information about the adverse events that have been reported to the FDA?
The FDA is posting reports containing adverse drug event information for Librela on a rolling basis in the CVM FOIA Electronic Reading Room. If the agency has additional information to share, it will be made available.
Additional Information
The FDA monitors the safety profile of all animal drugs after they reach the market, as widespread use of a drug in a large number of patients may uncover adverse events not observed prior to approval. Pharmaceutical companies (drug sponsors) are required to report all cases of adverse events they receive from the public, including pet owners and veterinarians, to the FDA. The agency evaluates adverse events and other safety information when it becomes available. When appropriate, FDA works with the drug sponsor to address any concerns. FDA may request updates to drug labeling, post-approval studies, or require additional or more frequent reporting. The FDA Center for Veterinary Medicine does not currently have the authority to mandate safety-related labeling changes.
For more information on drug sponsor’s responsibilities to report adverse events, see Post-approval Animal Drug Reporting Requirements.
The FDA also makes available Animal Drug Safety-Related Labeling Changes on a regular basis. Please see the button on the page to subscribe to email updates.
The FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring marketed animal drugs are safe and effective. For more information, please contact AskCVM@fda.hhs.gov.
FULL STATEMENT FROM ZOETIS:
On Monday, the FDA issued an update on Librela, which includes a summary and standard agency review of the adverse events that have been reported since launch in the U.S. Safety updates, issued in the years following a product launch, serve to educate the vet and pet owners and facilitate a discussion between the two.
The information shared by the FDA is consistent with what we’ve seen in our pharmacovigilance data. We maintain regular communication with the FDA to ensure the ongoing safety and efficacy of our products. We have been collaborating with the FDA to help contextualize the data. Zoetis is in discussions with the FDA on label updates and expects it will reflect post approval adverse event reporting and be similar to labels in other markets.
We continue to have the utmost confidence in the safety and efficacy of Librela. Since launching in Europe over three years ago, Librela has been used effectively with millions of dogs suffering from osteoarthritis pain. With more than 21 million doses distributed globally, no individual adverse event sign is reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) as <10 per 10="10">
In follow up to the FDA update, the Wall Street Journal posted an article on December 17, 2024, which similar to the piece published in April, presents an unbalanced view. The article incorrectly classifies the FDA’s action as a “warning” vs. a “Dear Vet” letter which serves as a safety update. The article also fails to mention that the FDA review does not contain new public data regarding adverse reactions, and that this data has been collected with the partnership of Zoetis to understand how best to support our customers who are using Librela in their practices.
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