Pulse - January 2025 - 15

UPDATES
FDA Suggests Label Change For Canine OA Drug Librela
The FDA's Center for Veterinary Medicine
is recommending that the label of
Librela (bedinvetmab injection) get a " post
approval experience " section and that
" owners be advised of adverse reactions
that may occur " after its administration.
Librela is manufactured by Zoetis, which
stands by the safety of the product for
control of pain associated with osteoarthritis
in dogs.
The FDA assessed adverse events reported
in dogs of various ages treated with Librela.
It said the most commonly noted adverse
events involved ataxia, anorexia, lethargy
and polydipsia. Deaths were also reported.
Additional concerns included increased urination
and excessive thirst.
The FDA approved Librela, a monoclonal
antibody drug, in May 2023, and it was
introduced to the marketplace later that
year. Before approval, the FDA reviewed
available studies and other data and determined
it to be safe and effective for its
intended use. Librela is dosed by weight
and labeled for subcutaneous injection
once a month.
" We continue to have the utmost confidence
in the safety and efficacy of Librela, "
Zoetis said in a statement. " 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 10,000 treated animals;
1 dose = 1 treated animal). "
Gulf Dolphins Showing
Fentanyl Traces, Study Says
Traces of fentanyl, a potent synthetic
opioid, have been detected in the blubber
of bottlenose dolphins living in the Gulf
of Mexico, according to a recent study by
researchers at Texas A&M University. The
team analyzed tissue samples from 89 dolphins
along the coasts of Texas and neighboring
Gulf states, discovering fentanyl in
30 individuals.
This discovery underscores how human
pharmaceutical pollutants are infiltrating
marine ecosystems.
Bottlenose dolphins are known to
PULSE
JANUARY 2025
accumulate various toxins, including pharmaceuticals,
in their fatty blubber. However,
the health implications of fentanyl
and other drugs on these marine mammals
remain unknown.
" Pharmaceuticals have become emerging
micropollutants and are a growing global
concern, " said Dara Orbach, the study's
lead author and an assistant professor of
marine biology at Texas A&M University,
Corpus Christi. She emphasized that the
presence of these substances has been
reported not only in freshwater ecosystems
and rivers but also in oceans around
the globe.
The findings, recently published in the journal
iScience, shed light on the pervasive impact
of human activities on aquatic environments.
The presence of fentanyl in dolphins' tissues
serves as a stark reminder of the interconnectedness
between human waste and
marine life, raising urgent questions about
the long-term consequences for both animal
health and the broader ecosystem.
Researchers hope this study will prompt
further investigation into the effects of
pharmaceutical pollution on marine species.
More Research Challenges
'Hybrid Vigor' in Dogs
When the renowned naturalist Charles
Darwin studied plant reproduction over
a century ago, he observed that crosspollinated
maize grew taller and produced
more seeds than self-pollinated plants. This
phenomenon, known as hybrid vigor or
heterosis, suggests that a diverse gene pool
can enhance an organism's vitality.
However, when it comes to dogs, the
long-held belief that crossbreeds and
mixed-breeds are inherently healthier than
purebreds is being challenged by recent
scientific studies.
Mixed-breed dogs, which have diverse
ancestry, and crossbreeds, which result
from two specific breeds, have often been
assumed to benefit from hybrid vigor. Yet a
study from England's Royal Veterinary College
(RVC), published in August, compared
the health of Labradoodles, cavapoos, and
cockapoos with their purebred ancestors
and found minimal overall differences.
Similarly, a November 2023 study by the
Dog Aging Project, a U.S. research initiative,
revealed that purebred dogs may
actually face lower risks for common
medical conditions on average than mixedbreed
dogs.
Both studies included limitations. They
relied on data reported by pet owners,
which might be less precise than observations
by veterinary professionals. Moreover,
the findings don't apply universally.
The researchers noted that purebreds
with significant genetic predispositions to
disease or extreme physical traits, such as
flat-faced breeds prone to breathing problems,
might benefit from outcrossing with
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