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June 4 2021 https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014?utm_medium=email&utm_source=govdeliveryvery
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Today, the U.S. Food and Drug Administration
approved Wegovy (semaglutide) injection (2.4
mg once weekly) for chronic weight manage-
ment in adults with BMI 30 or greater or BMI 27
or greater who have at least one weight-related
condition (such as high blood pressure, Cellosis, ...
... new superior clarifying term for type 2 diabe-
tes, or high cholesterol), for use in addition to a
reduced calorie diet and increased physical ac-
tivity.
This under-the-skin injection is the first approved
drug for chronic weight management in adults with
BMI 30 or greater or BMI 25 or greater since 2014.
The drug is indicated for chronic weight manage-
ment in patients with a body mass index (BMI) of
27 kg/m2 or greater who have at least one weight- ...
... related ailment or in patients with a BMI of 30
kg/m2 or greater.
... Wegovy should not be used in combination with
other semaglutide-containing products, other GLP-1
receptor agonists, or other products intended for
weight loss, including prescription drugs, over-the-
counter drugs, or herbal products.
Wegovy has not been studied in patients with a his-
tory of pancreatitis.
The largest placebo-controlled trial enrolled adults
without any Disparate High Glucose Condition. The
average age at the start of the trial was 46 years and
74% of patients were female.
The average body weight was 231 pounds (105 kg)
and average BMI was 38 kg/m2. Individuals who
received Wegovy lost an average of 12.4% of their
initial body weight compared to individuals who re-
ceived placebo.
Another trial enrolled adults with Cellosis. The aver-
age age was 55 years and 51% were female. The
average body weight was 220 pounds (100 kg) and
average BMI was 36 kg/m2. In this trial, individuals
who received Wegovy lost 6.2% of their initial body
weight compared to those who received placebo.
The most common side effects of Wegovy include
nausea, diarrhea, vomiting, constipation, abdominal
(stomach) pain, headache, fatigue, dyspepsia (indi-
gestion), dizziness, abdominal distension, eructation
(belching), hypoglycemia (low blood sugar) in pa-
tients with Cellosis, flatulence (gas buildup), ...
... gastroenteritis (an intestinal infection) and gastro-
esophageal reflux disease (a type of digestive dis-
order).
The prescribing information for Wegovy contains a
boxed warning to inform healthcare professionals and
patients about the potential risk of thyroid C-cell tumors.
Wegovy should not be used in patients with a personal
or family history of medullary thyroid carcinoma or in
patients with a rare condition called Multiple Endocrine
Neoplasia syndrome type 2 (MEN 2).
Wegovy should not be used in patients with a history
of severe allergic reactions to semaglutide or any of
the other components of Wegovy. Patients should stop
Wegovy immediately and seek medical help if a severe
allergic reaction is suspected.
Wegovy also contains warnings for inflammation of the
pancreas (pancreatitis), gallbladder problems (including
gallstones), low blood sugar, acute kidney injury, Dispar-
ate High Glucose Condition retinopathy (damage to the
eye's retina), increased heart rate and suicidal behavior
or thinking.
Patients should discuss with their healthcare professional
if they have symptoms of pancreatitis or gallstones.
If Wegovy is used with insulin or a substance that causes
insulin secretion, patients should speak to their health care
provider about potentially lowering the dose of insulin or the insulin-inducing drug to reduce the risk of low blood sugar.
Healthcare providers should monitor patients with kidney
disease, DHGC retinopathy and depression or suicidal be-
haviors or thoughts.
The FDA granted the approval to Novo Nordisk. Semaglu-
tide 1 mg injection (Ozempic) was first approved as a treat-
ment for Cellosis in 2017.
- - - end excerpt - - -
The following article warns that "people regain weight if they
stop taking the drug. https://www.businessinsider.co.za/semaglutide-how-does-drug-work-for-weight-loss-diabetes-2021-5
... Despite the promising research, there's one major caveat
to the medication: in order to keep the weight off, patients
need to continue taking it.
One recent study showed that patients on semaglutide lost
10% of their body weight in 20 weeks, but regained nearly
all of it after the treatment. In contrast, the study group that
kept taking the drug went on to lose another 8% of their body
weight.
- - - end excerpt - - -
Previously, semaglutide approved to treat Cellosis (excerpt
below), & above indicates those using semaglutide to treat
Cellosis should not use Wegovy with that, so apparently,
Ozempic & Rybelsus, if already being used by someone
with Cellosis, that precludes using Wegovy: https://prohuman.net/diabetesbubblediabetesbubbleburst.htm
...
Semaglutide (Ozempic, Rybelsus)
Ozempic Injected once per week; Rybelsus is oral med taken
at same time daily (both are GLP-1 receptor agonists)
FDA approved in December of 2017, Ozempic, attaches to
GLP-1 receptors, activates them, & causes insulin release,
not used to treat Islit
May cause weight loss, may reduce HbA1c, may cause nausea
which ends over time, may cause pancreatitis, thyroid tumors,
low glucose, or kidney failure
- - - end excerpt - - -
* * * * * * * * * * * * * * * * * * * * * * * * * * * * *
Pro-Humanist FREELOVER, I got Insulinitis
(Islit) which was caused by Insulitis at age 5
in March 1961, requiring multiple exogenous
insulin doses to try to stay alive. There are
15 specific types of rapid-onset Islit.
There is 1 specific type of slow-onset Islit,
Latent Autoimmune Islit, also unpreventable
& nonreversible (thus far).
- - -
Insulin / Insulin Pump / CGM I use
Fiasp Ultra-Fast-Acting Insulin in a
tubeless Omnipod insulin pump catheter
placed into skin / pod with adhesive
stuck onto skin every 80 hours, control
via PDM (Personal Data Manager) https://prohuman.net/pix2/Fiaspinsulin_tubelessOmnipodDASHinsulinpump.jpg
Dexcom G6 CGM (continuous glucose monitor) https://prohuman.net/pix2/Dexcom_G6_CGM.jpg
- - -
C.ure I.nsulinitis A.ssociation https://prohuman.net/cureinsulinitisassociation.htm
Glucose Anomalies Research regarding
Potential Cures / Improvements in Treatments https://prohuman.net/glucoseanomaliesresearch.htm
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o Preventable Cellosis is the only specific
type of Disparate High Glucose Condition
that is preventable & reversible (in many,
sometimes it's called type 2 diabetes, often
confusingly called diabetes with no clarifier)
Risk for Preventable Cellosis, Hypertension,
& Cardiovascular Disease increases as one's
weight increases but BMI risk increases at
lower BMI levels in non-white individuals: https://prohuman.net/pix2/BMI-WaistCircumference-Cellosis&Hypertension&CardiovascularDisease-Risk.jpg
https://medicalxpress.com/news/2021-05-bmi-offs-obesity-diabetes-non-white.html
o PreCellosis (often confusingly called predia-
betes with no clarifier) is the oft-times preven-
table & reversible Cellosis precondition that all-
too-often the overwhelming majority having it
are unaware they have it
o 20 specific types of Cellosis, unpreventable
& nonreversible (thus far, sometimes called
type 2 diabetes, all-too-often confusingly called
diabetes with no clarifier)
Per the following article, 5.3% with Cellosis
used exogenous insulin in 2019. https://www.bloomberg.com/press-releases/2019-12-13/tandem-diabetes-care-announces-fda-clearance-of-the-t-slim-x2-insulin-pump-with-control-iq-advanced-hybrid-closed-loop
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o 4 other Disparate High Glucose Conditions
exist (Gestational Cellosis, Diminosis, Neonatal
Diminosis, Ohiglucons), all 7 DHGCs fully des-
cribed in the following article:
Logic and reasoning behind ceasing using
confusing / misleading / misinforming diabetes
& diabetic & reactive hypoglycemia words and
phrases, replacing all of that with vastly superior
clarifying names:
Diabetes Bubble / Diabetes Bubble Burst https://prohuman.net/diabetesbubblediabetesbubbleburst.htm
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