- As
GLP-1 medications increase in popularity, researchers continue to examine
potential side effects.
- The
FDA is investigating reports of side effects from GLP-1 receptor agonists,
including suicidal ideation and hair loss.
- A
large new study found no link between semaglutide, the active ingredient
in GLP-1 drugs like Ozempic and Wegovy, and suicidal ideation.
GLP-1 drugs, such as
semaglutide, liraglutide, and tirzepatide, are type 2 diabetes medications that
have become popular over the last year for weight loss.
It’s estimated
around 24 million people in the United States, or 7% of the
population, will take GLP-1 medications by 2035.
Wegovy, Saxenda,
and Zepbound are
currently the GLP-1 medications that are FDA-approved as weight loss
drugs. Ozempic, Mounjaro,
and others may be prescribed off-label to help with weight loss.
As demand for these
medications increases, researchers and health experts are looking closely at
the potential side effects of GLP-1 receptor agonists.
The Food and Drug
Administration (FDA) is investigating reports of adverse events, including hair loss, suicidal thoughts,
and aspiration —
received by its FDA Adverse Event Reporting System (FAERS).
But new
research shows no link between semaglutide —
the active ingredient in certain GLP-1 medications like Ozempic and Wegovy —
and suicidal ideation.
Still, previous research
has shown that potential side effects of GLP-1 medications include gastrointestinal
issues such as nausea and vomiting, increased
heart rate, and an increased
risk for pancreatitis and
gastroparesis.
Despite the possible
side effects, GLP-1 drugs are considered safe. Medical News Today spoke
with three obesity experts to learn more.
Can GLP-1
drugs cause suicidal thoughts?
The FDA investigation is
not the first time an association between suicidal ideation and GLP-1
medications has been reviewed.
The European Medicines Agency (EMA) began investigating
this potential side effect in July 2023.
However, a recent study funded
by the National Institutes of Health (NIH) concluded there was no evidence that
GLP-1 drugs containing semaglutide cause suicidal thoughts.
The researchers examined
the medical record data of more than 1.8 million patients and found that
semaglutide is associated with a lower risk of suicidal ideations compared to other medications
prescribed for obesity or type 2 diabetes.
The researchers followed
patients for 6 months after they were prescribed the medications and found
those who took semaglutide for weight loss had a 0.1% risk of first-time
suicidal ideation. The risk of recurrent suicidal ideation increased to 7%
among subjects with a prior history of self-harming behavior.
However, not all GLP-1
drugs contain semaglutide, such as Mounjaro and Zepound, which means the
possibility of suicidal thoughts as a side effect may require further
evaluation, particularly among those with a history of mental health
conditions.
As a precaution, Dr. Seth Kipnis, medical director of bariatric and robotic
surgery at the Jersey Shore University Medical Center at Hackensack Meridian
Medical Group in New Jersey, told MNT that patients may wish to undergo screening for
psychological disorders before they’re prescribed GLP-1 medications.
GLP-1 drugs
may cause hair loss
The FDA is also
investigating hair loss, medically known as alopecia,
as a side effect of GLP-1 medication.
Dr. Mir
Ali, a bariatric surgeon and medical director of MemorialCare Surgical
Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA,
told MNT he was not surprised to hear that hair loss may
be an adverse effect of GLP-1 drugs.
“I’m not surprised
because any kind of significant weight loss, whether it’s on medications or
patient dieting on their own or even surgery, patients do experience hair
loss,” Dr. Ali explained. “It’s typically in women and it’s typically because
of the hormonal changes that accompany weight loss, and not necessarily a
direct effect of the medication.”
Dr.
Lydia C. Alexander, chief medical officer for Enara Health and
president-elect of the Obesity Medicine Association, agreed and said that the
most common causes
of hair loss during obesity treatment are rapid weight loss and trace
mineral and vitamin deficiency.
“In some studies, up
to 57% of patients undergoing metabolic bariatric surgery
experienced alopecia generally beginning at three months and lasting one year,”
Dr. Alexander continued.
“The most common vitamin
and mineral deficiencies seen in patients with alopecia following
bariatric surgery or weight loss are zinc, iron, folic acid, [and]
B12. Protein malnutrition may also cause hair thinning.
Over-supplementation of vitamin A is also reported to increase hair loss.”
“Since
GLP-1 medications cause greater and more rapid weight loss as do restrictive
very low calorie diets, it is not surprising to hear of case reports and
increased incidence of hair loss. In our experience, hair regrows three to six
months following weight stabilization, with nutrient replacement and dietary
monitoring/nutritional counseling.”— Dr. Lydia C. Alexander, obesity expert
Can
GLP-1 drugs cause difficulty swallowing?
Aspiration occurs when
liquid, food, or something else accidentally enters a person’s airway and makes
its way to the lungs. This can happen either when a person swallows something —
known colloquially as “going down the wrong way” — or food or liquid coming
back up from the stomach.
Dr. Ali said that
aspiration as a side effect of GLP-1 medications makes sense because one of the
effects of these medications is it slows down the emptying of the stomach.
“In some patients that
are more sensitive, instead of the stomach emptying as normal it’s staying full
for a longer period of time,” he explained. “So if they are sleeping on a full
stomach, some of the contents may go off and they can aspirate.”
“There is a warning for
patients who are to undergo surgery to stop these medications at least a week
before surgery to give your stomach a chance to kind of revert to normal,” Dr.
Ali added. “It’s important not to eat too soon before going to bed or
especially if you’re going to have surgery to hold medications before surgery.”
“If you overeat and
ignore the effect of the medication it will cause nausea, vomiting, and
possibly aspiration,” Dr. Kipnis added. “People need to follow appropriate
diets and food quantity guidelines for these drugs to work.”
Will the FDA
make changes to GLP-1 labels?
MNT asked an FDA spokesperson what prompted the
agency to investigate the potential side effects of GLP-1 drugs and whether
there were any plans for specific recommendations or further research into
causal effects that couldmerits labeling changes.
The spokesperson
told MNT the FDA monitors the safety of drugs throughout
their life cycle, including post-approval.
“In addition, the FDA
maintains a system of postmarketing surveillance and risk assessment programs
to identify and evaluate adverse events that did not appear during the drug
development process. If newly identified safety signals are identified, the FDA
will determine what, if any, actions are appropriate after a thorough review of
available data,” the FDA spokesperson said.
Dr. Alexander said the
FDA’s current evaluation of these potential side effects is the correct avenue
to aggregate, report, and further investigate medication-related side effects
to understand if there are additional minor to serious side effects that may
not have been seen or identified as significant during clinical trials.
“It is the job of the FDA to evaluate all drugs for
potential signals of serious risk and, if found to be significant, update and
release new safety information to prescribers and the public on the identified
medication,” Dr. Alexander noted.
When asked what needs to
be done to establish a direct link between taking GLP-1 drugs and side effects
like hair loss, suicidal ideation, or aspiration, Dr. Kipnis said that more
studies are needed to know what happens when someone stops taking these
medications.
“Short-term, these drugs
cause significant weight loss with minimal side effects, [but] what are the
long-term side effects?” Dr. Kipnis questioned. “How long can someone stay on
these drugs? “Obesity is a long-term problem. Are these drugs just a short-term
solution?”
Preventing
GLP-1 side effects
For those who may be
taking or considering a GLP-1 receptor agonist, all experts agree it is
important to go through a physician who will continuously monitor them and keep
them updated on any side effects they may experience.
“It’s important to thoroughly discuss side effects
with your medical provider,” Dr. Alexander said.
“Physicians board
certified in obesity medicine and advanced practitioners holding the NP/PA certificate of obesity medicine are
well-equipped to discuss the risks and benefits of GLP-1 medications, monitor,
and identify potentially serious medication side effects related to your
specific health profile.”
“These new drugs should
be prescribed by a doctor with an in-person visit that includes a physical exam
and weight being taken,” Dr. Kipnis said.
“Patients should also be
seeing a registered dietitian while taking these medications. Routine follow-up
with the prescribing doctor should be required to avoid complications and to
monitor for patient compliance.”
“Patients
taking these medications should meet the current FDA guidelines. Many of these
are not being done across the country. These drugs are being used for cosmetic
reasons for non-obese patients, exclusively prescribed through telemedicine, or
being prescribed by providers who have never managed obesity before and may not
be qualified to be prescribing them.”— Dr. Seth Kipnis, bariatric sugeon.
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