Topic Search_ ___FDA
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Georgia Piedmont Technical College *
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Course
2113
Subject
Medicine
Date
Dec 6, 2023
Type
Pages
3
Uploaded by BarristerDugong2439
Topic Search: __
_FDA
Name: __Aden Gebregergs________________ Date: __Sep/29/2023________ Period:
6th_____________
Name of Article/Reading: __
FDA Adds Intestinal Blockage Reports to Ozempic Labeling.
Author(s): _
Sophie Putka______
_________________Review By: (Name of
Physician)__N.A__________________
1.
Reading and Understanding
2.
Summarize the main points/facts in at least 6 paragraphs below:
Paragraph #1:
The FDA has included postmarketing reviews of ileus, or blocked intestines, in
the drug labeling for semaglutide (advertised as Ozempic). The drug label emphasizes that
because of the voluntary nature of those reports and uncertainty concerning the populace size, it's
tough to estimate their frequency or set up an instantaneous link to drug exposure.
Paragraph #2:The labeling for semaglutide 2.4 mg (known as Wegovy), indicated for obesity,
already acknowledges the potential adverse reaction based on postmarketing data. This includes
gastrointestinal disorders such as acute pancreatitis, necrotizing pancreatitis, and ileus. Ileus
leads to symptoms like cramping, pain, constipation, vomiting, and loss of appetite.
Paragraph #3:Semaglutide, an injectable GLP-1 receptor agonist, is primarily prescribed for type
2 diabetes but has gained popularity off-label for weight loss.
Paragraph #4:Treatment for ileus often necessitates hospitalization for stabilization, followed by
interventions like barium or air enema. In cases of complete intestinal obstruction, surgery might
be required. For pseudo-obstruction, doctors might prescribe medication to induce muscle
contractions or address the underlying cause.
Paragraph #5:The labeling for tirzepatide (Mounjaro), a dual GIP/GLP-1 receptor agonist used
for type 2 diabetes, was also modified to include ileus as a potential side effect based on
postmarketing reports. Both semaglutide and tirzepatide can lead to gastroparesis, a condition
where stomach emptying is delayed, which has raised concerns, particularly for surgical patients.
2.
Write down any unfamiliar words or phrases
Ileus, GLP-1 receptor agonist,Postmarketing reports,Acute pancreatitis,Necrotizing
pancreatitis,Gastroparesis,Aspiration
3.
Look up the definition of at least one of the words from question 2.
Ileus: Ileus refers to a condition where there is a blockage of the intestine that inhibits the
normal flow of its contents. This can lead to symptoms such as cramping, pain, constipation,
vomiting, and loss of appetite.
4.What is/are the main point(s) of the entire reading/article?
●
The FDA has added postmarketing reports of ileus to the labeling for semaglutide
(Ozempic), a drug used for type 2 diabetes that has gained popularity as a weight-loss
medication.
●
The labeling for another drug, semaglutide 2.4 mg (Wegovy), indicated for obesity,
already includes ileus as a potential adverse reaction based on postmarketing data.
●
Ileus can lead to various uncomfortable and serious symptoms and may require
hospitalization and medical interventions for treatment.
5.
Write down a minimum of 3 questions you still have after reading the article.
(Use Level 1, 2, and 3 words)
L1: What are the common side effects of Ozempic (semaglutide)?
L2: How does ileus impact the digestive system, and what are its potential complications?
L3: Are there any alternative medications or treatments available for patients who
experience adverse reactions to semaglutide or tirzepatide?
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