• FDA approves Wegovy for weight reduction for BMI 30 or greater or B

    From _@21:1/5 to All on Thu Jul 22 17:27:17 2021
    Follow-up:

    An individual (a consumer representative who
    voted for FDA approval of the drug) worried
    that "The side effects of Wegovy are very scary
    and, in my opinion, would outweigh the benefits
    of someone taking the drug just for weight loss." https://medshadow.org/weight-loss-drug-wegovy-could-offer-more-risks-than-benefits/

    The individual used the diabetes or diabetic
    words 22 times without any clarifier, & the sole
    clarifier she used was 'type-1' once, even though
    semaglutide is used to treat Cellosis (new super-
    ior clarifying term for type 2 diabetes) & would
    be a questionable drug to use for anyone ...

    ... with Islit (Insulinitis, near-total to total loss of
    endogenous insulin). In fact, the Ozempic & Ry-
    belsus types of semaglutide are specifically for
    Cellosis & there is no mention of Wegovy as
    recommended for weight loss in Islit individuals: https://reference.medscape.com/drug/ozempic-rybelsus-wegovy-semaglutide-1000174

    On Friday, June 4, 2021 at 4:44:56 PM UTC-5, _ wrote:

    - - -
    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
    - - -

    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

    - - -

    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

    - - -

    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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