- Poison control centers
across the United States are witnessing a concerning increase in inquiries
related to semaglutide, an injectable medication used for diabetes
management and weight loss.
- Reports of inadvertent
overdoses have led to hospitalizations in some cases, with symptoms
including intense nausea, vomiting and abdominal discomfort.
- Data from America’s Poison
Centers reveals a startling 15-fold increase in semaglutide-related calls
between January and November, primarily attributed to dosage errors, amid
concerns over the safety of compounded formulations of the drug.
Semaglutide,
a glucagon-like peptide-1 receptor agonist or GLP-1 analog, gained approval from the Food and Drug Administration (FDA) in
2017.
The medicine is marketed as Ozempic for
diabetes management and Wegovy for
weight loss.
In 2023, from January to November, America’s
Poison Centers have reported recording nearly 2,941 calls related to
semaglutide, marking a more than 15-fold increase compared to 2019.
In 94% of these cases, semaglutide was the sole
reported substance involved.
Fortunately, these cases have demonstrated
resolution following treatment involving intravenous fluids and anti-nausea
medications.
Semaglutide
for diabetes management or weight loss
Following the endorsement of Ozempic by
celebrities on social media in 2022 for weight loss, there was a surge in
demand that outpaced the available supply.
Consequently, the drug was recorded as being in short
supply. in the
FDA’s database by March 2022.
This shortage opened the door for select
pharmacies with appropriate qualifications to produce compounded versions of
the drug.
These compounded formulations of semaglutide
often diverge from the patented drug and frequently incorporate semaglutide
salts, specifically semaglutide sodium and semaglutide acetate.
The
FDA has raised concerns. regarding the safety and efficacy of
these salt-based formulations, as they have not undergone the rigorous testing
and approval processes applied to the patented medication.
Consequently, they do not qualify for the
compounding exemption granted to drugs facing shortages under the law.
In certain instances, compounded versions are
marketed in unapproved dosage strengths.
The FDA has initiated legal action by issuing
warning letters to at least two online retailers, urging them to cease
distribution of these unapproved versions.
Lawsuits
against clinics marketing unapproved formulations
Pharmaceutical manufacturer Novo Nordisk has also filed lawsuits against six
entities, including medical spas, medical clinics and weight loss clinics, seeking to prohibit the sale of these knock-off
semaglutide formulations.
It is important to understand that all
medicines must go through clinical trials to assess their safety and efficacy.
Any changes to formulations of an approved
medicine must also follow strict procedures to ensure they remain safe and
efficacious.
Despite these regulatory concerns, compounded
versions remain popular, primarily due to their potential for reduced
out-of-pocket costs, particularly in cases where insurance coverage is
unavailable.
The FDA took a public stance against the use of
compounded semaglutide formulations in June, advising against their usage when
prescription forms of the medication are accessible.
The agency cited adverse event reports it had
received following the use of compounded semaglutide.
Are
adverse events linked to patented or compounded drugs?
Poison control centers find it challenging to
identify whether the reported symptoms are linked to the patented medications
or the compounded versions.
However,
some state poison center directors express the belief that many of these calls
are attributable to the compounded formulations.
There is no specific antidote available for
countering a semaglutide overdose.
Semaglutide has a relatively long half-life of
approximately one week, meaning it takes a week to eliminate half of the drug
from the body.
Consequently, emergency departments and
hospitals can only provide supportive care to patients, administering
intravenous fluids and anti-nausea medications while the drug gradually
metabolises and exits their system.
What are
the signs of a semaglutide overdose?
Medical News Today spoke to three
experts about the surge in semaglutide-related adverse events.
Dr. Jared L. Ross, professor and medical director at the Henry
Ford College Paramedic Program and Medical Director for Trauma Services at
Bothwell Regional Health Center, explained what happens if someone takes too
much Ozempic, Wegovy or another GLP-1 agonist drug, noting that “the most
common symptoms are nausea, vomiting, and occasionally diarrhea.”
“Usually, this resolves on its own, but in
large overdoses, the symptoms can be persistent causing patients to become
severely dehydrated requiring IV fluids and anti-nausea medication,” Dr. Ross
explained.
“Other symptoms include
low blood sugar or low blood pressure which can give you a headache or make you
confused, lightheaded, dizzy, or even faint. Low blood sugar may make some
people jittery, irritable, and even aggressive.”
– Dr. Jared L. Ross
“Most of these brand-name medications are
supplied in pre-filled injection pens, similar to how many people use insulin,
making overdose rare,” he also noted.
Why are
people overdosing on semaglutide?
“However,” Dr Ross warned, “due to the current
high demand and short supply of these medications compounding pharmacies are
allowed to sell the medication in vials. With very small doses being typical,
often 0.05-0.1 ml [mililiters], it is easy for patients to make mistakes and draw
up too much, even 10-fold overdoses are common. With the exception of some
doses of Ozempic, these pre-filled pens deliver a fixed dose making overdose
rare.”
Taylor Knese, nurse practitioner, agreed, noting that “it is
possible that there has been an increase in overdoses related to this type of
medication due to the sheer increase in its use.”
“Previously, this medication was only FDA
approved for type 2 diabetics. These patients are seen more frequently in the
clinic and have regular blood sugar monitoring. However, recently these
medications have gained increasing popularity for weight loss,” Knese noted.
“If patients do not follow the medication
instructions and are giving doses higher than recommended this will more likely
lead to negative outcomes/overdose. Education should always be provided to
patients on correct storage, use and side effects, especially symptoms of low
blood sugar,” she advised.
Significant
public health concern
Dr. Zeeshan Afzal, of Welzo,
pointed out that “the rise in overdoses of GLP-1 agonist drugs poses
significant public health concerns.”
“For patients, it highlights the need for
thorough education on the proper use of these medications, understanding the
risks and recognizing overdose symptoms,” he told us.
“For the public and
healthcare system, it underscores the importance of careful prescribing
practices, monitoring of drug use, and raising awareness about the potential
risks associated with these medications. Additionally, it calls for research
into safer, more effective treatments for diabetes and obesity and strategies
to prevent medication misuse.”
Dr. Zeeshan Afzal
Dr. Ross urges anyone who may be experiencing
an overdose to seek medical care right away.
“You can reach your local poison control center
by calling 1-800-222-1222 [in the United States]; they can help you determine
if you need to go to the emergency room. If you are concerned, call 911 or go
to the nearest hospital,” Dr. Ross advised.
America’s
Poison Centers also encourage people to contact their Poison Help phone number
and to use their website as a resource, saying, “for poisoning related-related
questions, or if you need emergency assistance please contact Poison Help at
1-800-222-1222 or visit PoisonHelp.org.”
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