Drug Injury Watch

Gastroparesis Case Reports Involving the Use of GLP-1 Receptor Agonists Semaglutide and Dulaglutide

Learn About Related Symptoms and Diagnosis Process for Gastroparesis, a Side Effect of Ozempic, Wegovy, Rybelsus, and Trulicity

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In this article, we present some gastroparesis case reports involving the use of GLP-1 receptor agonists semaglutide (e.g., Ozempic, Wegovy, Rybelsus) or dulaglutide (e.g., Trulicity) that have been published recently by medical journals. These gastroparesis case reports discuss specific patient profiles, related symptoms, and the diagnosis process for gastroparesis, a side effect of Ozempic, Wegovy, Rybelsus, or Trulicity.

We have written previously about gastroparesis associated with Ozempic, Wegovy, and Rybelsus, three popular GLP-1 receptor agonists containing semaglutide.

Ozempic, Wegovy, Other GLP-1 Semaglutide Weight-Loss Drugs Linked to Gastroparesis in Recent Medical Study -- Researchers Compared Semaglutide Drugs, Such as Ozempic and Wegovy, to Contrave, a Non-GLP-1 Drug, in Weight-Loss Patients (10/24/23)

Severe Stomach Conditions in Patients Using Semaglutide Weight Loss Drugs From Novo Nordisk -- Ozempic, Rybelsus, and Wegovy Use Might Cause Gastroparesis, Gastric Stasis, or Stomach Paralysis (9/13/23)

Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening -- Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages (9/1/23)

Now we point out three gastroparesis case reports involving the use of semaglutide (e.g., Ozempic, Wegovy, Rybelsus) or dulaglutide (e.g., Trulicity) that we found in two medical journal articles, and present some valuable information from each of these gastroparesis case reports.

(1) Tendency of Semaglutide to Induce Gastroparesis: A Case Report

A 53-year-old woman with a medical history of depression, obesity stage 2, and obstructive sleep apnea presented to the hospital due to nausea and abdominal pain for the last three weeks. She also reported a weekly intramuscular injection of 0.5 mg of semaglutide for the preceding four months for weight loss, with an estimated 40-pound loss during this period. She did not escalate the dose of semaglutide for weight loss as recommended, as she was satisfied with the response to the initial dose....

In this case, the patient's use of semaglutide and her symptoms of gastroparesis seem to be strongly related. By stimulating glucagon-like peptide-1 (GLP-1) receptor agonists, it increases incretin action. Furthermore, better blood glucose levels are achieved by increased glucose-dependent insulin secretion, decreased hepatic gluconeogenesis, delayed gastric emptying, and inhibited glucagon release. Additionally, semaglutide encourages weight loss by delaying gastric emptying and decreasing energy intake. Semaglutide mainly binds to plasma proteins, has a half-life of approximately one week, and remains in circulation for about five weeks after the last dose. Its effects increase in a dose-proportional manner, and a steady state is achieved after four to five weeks of once-weekly administration.

The exact mechanism by which semaglutide may cause gastroparesis is unknown. Nonetheless, it is well recognized that GLP-1 receptors regulate stomach emptying and motility. Therefore, the stimulation of these receptors may cause gastroparesis by delaying the stomach's emptying....

Proof of delayed gastric emptying in gastric emptying studies is required for the diagnosis, in addition to the absence of mechanical blockage. Consequently, upper and occasionally lower endoscopies are frequently included in the workup. The decision to forgo a gastric emptying study for our patient was made due to financial concerns and clinical evidence observed during repeated endoscopy, which included the presence of food material in the stomach 24 hours apart and the absence of mechanical blockage. A gastric emptying study is considered positive for gastroparesis if there is more than 60% of retaining food after 2 hours or 10% after 4 hours.  [Footnotes omitted]

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(2) Medication-Induced Gastroparesis: A Case Report

The first case is that of a 52-year-old female with a long-standing history (10 years) of type 2 DM who was referred to our clinic for a 7-month history of postprandial epigastric pain, accompanied by fullness, bloating, and nausea. Multiple pharmacologics were tried to relieve the symptoms such as proton pump inhibitors and antispasmodics (anticholinergics), however with no relief. Laboratory tests and computed tomography of the abdomen were unremarkable. Patient had an HbA1c of 5.7% (well-controlled diabetes). Prior upper and lower endoscopies showed no evidence of obstruction, and biopsy was negative for Heliobacter pylori. A hepatobiliary iminodiacetic acid (HIDA) scan was also done in the past which ruled out gallbladder dyskinesia, and an abdominal Doppler blood flow study ruled out median arcuate ligament syndrome. Upon extensive history taking, it was found that the patient had started semaglutide (a glucagon-like peptide-1 [GLP-1] receptor agonist) subcutaneous injection weekly, approximately 1 month prior to the onset of symptoms. A 4-hour scintigraphic gastric emptying study (GES) showed 24% retention of isotope in the stomach at 4 hours which indicates delayed gastric emptying (GE) as gastric residual remaining at 4 hours should be <10%. Semaglutide was subsequently held for 6 weeks with resolution of symptoms. A repeat GES was then performed and showed resolution of delayed GE (Table 1).

The second case is that of a 57-year-old female with a long-standing history (16 years) of type 2 DM presenting with abdominal bloating, nausea, and vomiting for the past year. Labs were significant for a HbA1C of 8.2%. Previous upper endoscopy and colonoscopy did not reveal any obstruction or other abnormalities; however, she never received a GES. In addition, patient started dulaglutide subcutaneous weekly injection (GLP-1 receptor agonist) approximately 15 months ago. A 4-hour scintigraphic GES showed 35% retention of isotope in the stomach at 4 hours, revealing delayed GE. Subsequently, dulaglutide was discontinued for 4 weeks with gradual resolution of symptoms. A repeat GES was then performed and showed normalization of GE (Table 2).

We continue to investigate drug injury lawsuits for people who used Ozempic, Rybelsus, Wegovy, or Trulicity and then were diagnosed with serious gastrointestinal side effects like gastroparesis, gastric stasis, or stomach paralysis.

If we can assist you or someone you know, you can contact me by email ([email protected]) or phone (800-426-9535).

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Prolia Increased Risk Of Hypocalcemia In Patients With Chronic Kidney Disease (CKD) Can Be 20-Times Higher Than Pills

Prolia "Black Box" Warning: Harm From Severe Hypocalcemia Ranges From Hospitalization For Life-threatening Events To Death

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A January 2024 JAMA Original Investigation article, "Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients", in summary, presents evidence of a Prolia increased risk of hypocalcemia in patients with chronic kidney disease (CKD) that can be 20-times higher than bisphosphonate pills.

From the "Key Points" beginning of this online JAMA article about Prolia and severe hypocalcemia, we get a clear picture of the great extent of this new Prolia side effect:

Question Is there a difference in risk of severe hypocalcemia among female dialysis-dependent Medicare patients treated for osteoporosis with [Prolia (denosumab)] vs oral bisphosphonates?

Findings In this cohort study of 1523 dialysis-dependent patients initiating [Prolia (denosumab)] and 1281 initiating oral bisphosphonates, the weighted cumulative incidence of severe hypocalcemia (ie, <7.5 mg/dL [1.88 mmol/L] or emergent care) at 12 weeks was 41.1% with [Prolia (denosumab)] , 60 mg, vs 2.0% with oral bisphosphonates (weighted risk difference, 39.1% [95% CI, 36.3%-41.9%]).

Meaning Treatment of older female dialysis-dependent patients with [Prolia (denosumab)] was associated with a statistically and clinically significant increased risk of severe hypocalcemia compared with oral bisphosphonates.

To make clear the significance of these findings, and why the FDA mandated a Prolia "Black-Box" warning, we turn to this January 19, 2024, MedPage Today news report, "Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis":

Many women on dialysis quickly developed severe hypocalcemia after starting denosumab (Prolia) for osteoporosis, Medicare data showed.

During the first 12 weeks of treatment, 41.1% of women on [Prolia (denosumab)] developed severe hypocalcemia compared with 2.0% of those taking oral bisphosphonates, reported a group of largely FDA researchers led by Steven Bird, PhD, PharmD, of the agency offices in Silver Spring, Maryland.

This translated to more than a 20-times higher risk for incident severe hypocalcemia with [Prolia (denosumab)] (weighted risk ratio 20.7, 95% CI 13.2-41.2), according to the retrospective cohort study in JAMA.

Supported by these new findings, the FDA on Friday added a boxed warning over the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD) taking [Prolia (denosumab)] for osteoporosis.

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We get some background about this Prolia - hypocalcemia safety issue from another January 19, 2024, MedPage Today news report, "FDA Slaps Boxed Warning on Osteoporosis Drug":

The label update comes after the FDA initially issued a safety alert in November 2022 about [Prolia's] potential hypocalcemia risk in dialysis-dependent women. The safety alert was prompted after interim results from maker Amgen's ongoing safety study -- required upon approval -- that indicated an increased risk of hypocalcemia in patients with advanced kidney disease.

[Prolia (denosumab)] was first approved in 2010 for postmenopausal women with osteoporosis at high risk for bone fracture and later picked up indications to treat men with osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in those receiving androgen-deprivation therapy for prostate cancer and for women receiving aromatase inhibitor therapy for breast cancer. (Denosumab is also approved under the trade name Xgeva to reduce the risk of bone-related events in certain cancer patients.)

For more detailed information about the new "Black-Box" warning for this Prolia hypocalcemia side effect, we direct you to the January 19, 2024 "Drug Safety Communication: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)."

We will continue to monitor this still-developing Prolia drug safety issue involving severe hypocalcemia in Porlia patients with advanced chronic kidney disease (CKD) and share significant developments here on Drug Injury Watch.

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Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed

December 2023 JAMA Ophthalmology Viewpoint Piece About Syfovre Calls for Independent and Unbiased Evaluation

 

(Posted by Tom Lamb at Drug Injury Watch)

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UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.  [Emphasis added.]

(2/28/24)

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Since the February 2023 FDA approval of Syfovre (pegcetacoplan), Apellis Pharmaceuticals has had to contend with various Syfovre safety issues related to its eye injection treatment for geographic atrophy. In our December 4, 2023 post, "Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections", we reported on the November 2023 Syfovre label change that came after numerous cases of eye inflammation and severe vision loss.

A Viewpoint piece published December 7, 2023, online by JAMA Ophthalmology, "Concerning Syfovre Approval for Geographic Atrophy", touches upon these Syfovre safety issues. It begins as follows:

Syfovre (pegcetacoplan) was recently approved by the US Food and Drug Administration (FDA) as a treatment to slow the rate of geographic atrophy (GA) growth, although not as a treatment for visual acuity. Though there is much hope and marketing about tissue preservation with this drug, to date, there are substantial safety and efficacy concerns that might give clinicians pause before widespread adoption.

That December 2023 JAMA Ophthalmology Viewpoint piece was reported on by Peter Wehrwein, Managing Editor of Managed Healthcare Executive, in his December 7, 2023 article, "Independent Assessment of Syfovre Needed, Argues JAMA Ophthalmologist Viewpoint":

An independent panel of retinal specialists and statisticians should assess the clinical trial data for Syfovre (pegcetacoplan injection) and provide an unbiased evaluation of the drug in light of the lack of peer-review publication and a complete FDA review, argues Ira Schachar, M.D., M.Sc., the author of an opinion piece published today in JAMA Ophthalmology.

Schachar also suggests that widespread use of Syfovre should wait until there is a complete FDA scientific analysis of the drug or a peer-reviewed publication of the study results. He says the data released by Apellis Pharmaceuticals raises methodological questions and he questions whether “repeated measures and missing data have been appropriately handled.” Schachar, who was an assistant professor at Stanford prior to joining the North Bay group, says in the one-page viewpoint piece that questions about the Syfovre statistics are “particularly important” because of the high dropout rates from two important, phase 3 trials for the drug called OAKS and DERBY.

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In a December 9, 2023 Editor’s Note by Neil M. Bressler, MD, Editor in Chief of the JAMA Ophthalmology medical journal, published as a Comment to "Concerning Syfovre Approval for Geographic Atrophy", it is pointed out:

Since the submission, revision, and acceptance of this Viewpoint [by Dr. Schachar], the primary outcome results of two 24-month, multicenter randomized clinical trials to assess the efficacy and safety of [Syfovre (pegcetacoplan)] compared with sham treatment in patients with geographic atrophy were published.... This information was not publicly available at the time of acceptance of this Viewpoint. A formal publication to address this should be published in JAMA Ophthalmology by early 2024.

The results of those two clinical trials referred to therein, OAKS and DERBY, were reported in this medical journal article, "Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials", published October 21, 2023, by The Lancet.

In the Interpretation part of the Abstract for this Lancet medical journal article, lead author Jeffrey S. Heier, M.D., of Ophthalmic Consultant of Boston, and his colleagues stated:

[Syfovre (pegcetacoplan)], the first treatment approved by the US Food and Drug Administration for geographic atrophy, slowed geographic atrophy lesion growth with an acceptable safety profile.

The OAKS and DERBY trials were funded by Apellis Pharmaceuticals.

We will continue to monitor the various Syfovre safety issues and report further significant developments here on our Drug Injury Watch website.

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Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections

November 2023 Syfovre Label Change Comes After Earlier Reports of Eye Inflammation and Severe Vision Loss

 

(Posted by Tom Lamb at Drug Injury Watch)

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UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.  [Emphasis added.]

(2/28/24)

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We have been writing about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects since July 2023. This latest article is about the November 2023 Syfovre label change that adds new warnings about retinal vasculitis and/or retinal vascular occlusion associated with Syfovre injections.

For background, here is a general Syfovre timeline bringing us up to the present time:

• Syfovre (pegcetacoplan injection) was approved by the FDA in February 2023 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD);
• In July 2023 the first reports of retinal vasculitis associated with Syfovre became public. In turn, Apellis Pharmaceuticals launched an investigation for retinal vasculitis cases and other eye-related side effects; and,
• Then Apellis suggested in August 2023 that an issue related to certain injection kits used for Syfovre may be a possible cause of eye inflammation sometimes leading to retinal vasculitis and severe vision loss, Apellis urging doctors to switch to a different injection kit.

With this November 2023 Syfovre label change it now seems that the retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as had been suggested by Apellis.

The two newly added subsections to the Syfovre Prescribing Information document "Revised: 11/2023" version (accessed 12/4/23) with warnings about retinal vasculitis are set forth below:

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE [see Adverse Reactions (6.2)]. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay.

6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of SYFOVRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: retinal vasculitis with or without retinal vascular occlusion.

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Here is a list of our earlier Drug Injury Watch articles about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects:

Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation -- A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported [11/10/2023]

Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further "Explanation" -- On That Aspect, in August 2023 Apellis Asked Doctors to Stop Using Syfovre Injection Kits With a 19-gauge Filter Needle [10/13/2023]

Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events -- Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues  [8/17/2023]

Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists -- A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation  [7/28/2023]

Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness -- American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre  [7/19/2023]

We are investigating Syfovre drug injury lawsuits for patients who developed retinal vasculitis, eye inflammation, severe vision loss, or blindness after receiving their Syfovre injection.  To be clear, these lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

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Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation

A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported

 

(Posted by Tom Lamb at Drug Injury Watch)

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UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.  [Emphasis added.]

(2/28/24)

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At the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO), various Syfovre patients eye side effects cases were discussed by William J. Johnson, M.D., of the Wolfe Clinic in Iowa. These Syfovre side effects cases range from hemorrhagic occlusive vasculitis-type inflammation with continued blindness to uveitis to vision loss to symptomatic floaters.

From this November 3, 2023 news report, "Details on 5 Cases of Complications From Syfovre Injections | AAO 2023", by Peter Wehrwein, Managing Editor of Managed Healthcare Executive, we get the following information about this significant Syfovre 2023 AAO Meeting presentation:

One of the patients experienced hemorrhagic occlusive vasculitis-type inflammation and continues to have no light perception — clinical terminology for blindness — in the treated eye, reported William J. Johnson, M.D., a retinal fellow at the Wolfe Clinic, which has 24 locations in Iowa.

Johnson... said Wolfe Clinic retina specialists administered 129 injections of Syfovre in 96 eyes of 84 patients between March 2023 and mid-July, when it paused used of Syfovre injections because of the complications.

Here are some of the details about the five cases Johnson presented at the AAO meeting. He provided a few more details in a subsequent phone conversation:

• An 80-year-old male who developed silicone oil droplet complications experienced symptomatic floaters. There was no objective change in vision or inflammation, but the patient decided not to have any further treatments....
• A 72-year old woman developed intermediate and anterior (front of the eye) uveitis following her first injection with Syfovre. Her vision returned to its baseline level after intensive topical steroid treatment.
• An 86-year-old woman developed uveitis after her second Syfovre injection. Her condition improved initially with steroid drops but then worsened. She was treated with antibiotic and steroid injections in the eye but did not improve. After more intense steroid treatment was started, her vision slowly improved over 10 weeks and returned to being just below baseline. Johnson said there was some debate about how this case should be classified, with Wolfe specialists seeing some findings as evidence pointing to pre-existing branch retinal vein occlusion but others seeing them as evidence of hemorrhagic vasculitis without occlusion.
• A 72-year-old female presented with vision loss seven weeks after a Syfovre injection. The person’s vision improved after three monthly treatments with Vabysmo (faricimab), an anti-vascular endothelial growth factor (VEGF) used to treat neovascular, or “wet,” age-related macular degeneration (AMD). She had converted from dry to wet AMD, and Johnson said such cases were seen in clinical trials of Syfovre and are a known complication. Her vision improved with the Vabysmo treatments but never fully recovered and remained below her baseline level.

The fifth case was the patient who experience no light perception in his treated eye. Johnson said he was a 96-year-old man who presented nine days after his first injection with decreased vision, pain, elevated pressure in the eye, and vasculitis. He was initially treated with antibiotics, steroids and topical eye hypertensives. That treatment was followed by stronger steroids and then by anti-VEGF therapy. Johnson said the baseline vision of the treated eye was 20/60.

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Suber S. Huang, M.D., MBA, said this Syfovre patients eye side effects cases presentation was one of the most important of this 2023 AAO Annual Meeting in San Francisco in early November. Notably, it was the first major AAO meeting since the FDA approved Syfovre in February 2023 to treat geographic atrophy (GA).

On November 4, 2023, Managed Healthcare Executive made available online a brief interview (2:49 video) with Dr. Huang on a page titled "Syfovre Complications Discussed in Late-Breakers Session | AAO 2023".

We have been following this still-developing drug safety issue involving Syfovre patients eye side effects cases since July 2023. Our most recent article, "Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further 'Explanation'", was posted last month, in mid-October 2023.

At present, we are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who developed occlusive retinal vasculitis, eye inflammation, vision loss, or blindness after receiving Syfovre injections.

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Ozempic, Wegovy, Other GLP-1 Semaglutide Weight-Loss Drugs Linked to Gastroparesis in Recent Medical Study

Researchers Compared Semaglutide Drugs, Such as Ozempic and Wegovy, to Contrave, a Non-GLP-1 Drug, in Weight-Loss Patients

 

(Posted by Tom Lamb at Drug Injury Watch)

 

An October 2023 medical journal article presented the results of a recent study comparing patients who used two different types of weight-loss drugs to see whether drugs containing the GLP-1 semaglutide showed Ozempic and Wegovy associated with gastroparesis, a gastrointestinal condition also referred to as stomach paralysis.

Even those two Novo Nordisk drugs, Ozempic and Wegovy, each have semaglutide as their active ingredient, they were approved by the FDA for different purposes. Ozempic is intended for patients with diabetes and Wegovy was approved for those with obesity. However, over the past couple of years, Ozempic has been increasingly used "off-label" as a weight-loss drug, too.

For this recent medical study, semaglutide drugs such as Ozempic and Wegovy were compared to Contrave, a non-GLP-1 weight-loss treatment.  It is important to point out that for this study none of the patients had diabetes and all of the patients were prescribed the two different types of drugs for weight loss. The reason this fact is significant: "Diabetes is the most common known underlying cause of gastroparesis." See "Symptoms & Causes of Gastroparesis", from the National Institute of Diabetes and Digestive and Kidney Diseases (accessed 10/24/23).

So as regards possible Ozempic-gastroparesis drug injury lawsuits against Novo Nordisk for failure to warn about this serious side effect, the better cases will involve non-diabetic patients using Ozempic "off-label" as a weight-loss treatment.

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With that established, we now direct you to the medical journal article we referred to at the outset of this piece. On October 5, 2023, the Journal of the American Medical Association (JAMA) published online this Research Letter, "Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss", which begins with this introduction to the medical study:

Glucagon-like peptide 1 (GLP-1) agonists are medications approved for treatment of diabetes that recently have also been used off label for weight loss. Studies have found increased risks of gastrointestinal adverse events (biliary disease, pancreatitis, bowel obstruction, and gastroparesis) in patients with diabetes. Because such patients have higher baseline risk for gastrointestinal adverse events, risk in patients taking these drugs for other indications may differ. Randomized trials examining efficacy of GLP-1 agonists for weight loss were not designed to capture these events due to small sample sizes and short follow-up. We examined gastrointestinal adverse events associated with GLP-1 agonists used for weight loss in a clinical setting. [footnotes omitted]

As mentioned above, this recent medical study found that the use of GLP-1 agonists containing the active ingredient semaglutide, such as Ozempic and Wegovy -- when compared with Contrave, a non-GLP-1 drug with the active ingredients naltrexone and bupropion -- was associated with increased risk of gastroparesis.

We are investigating possible drug injury lawsuits against Novo Nordisk for non-diabetic patients who were diagnosed with gastroparesis while using Ozempic "off-label" as a weight-loss treatment as well as Wegovy as an obesity treatment.

In addition, we are investigating gastroparesis cases involving Rybelsus, approved by the FDA as Type 2 diabetes treatment, when it was being used "off-label" for weight loss by people who do not have diabetes.

If you want to learn more, here are a few of our earlier Drug Injury Watch articles about gastroparesis and other gastrointestinal side effects associated with Ozempic, Wegovy, and Rybelsus:

• Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023 -- Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction (9/28/23)
• Severe Stomach Conditions in Patients Using Semaglutide Weight Loss Drugs From Novo Nordisk -- Ozempic, Rybelsus, and Wegovy Use Might Cause Gastroparesis, Gastric Stasis, or Stomach Paralysis (9/13/23)
• Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening -- Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages (9/1/23)

Feel free to contact us about a possible drug injury case involving Ozempic, Wegovy, and Rybelsus. Any such lawsuit would be filed against Novo Nordisk, the responsible drug company, but not your doctor.

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Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further "Explanation"

On That Aspect, in August 2023 Apellis Asked Doctors to Stop Using Syfovre Injection Kits With a 19-gauge Filter Needle

 

(Posted by Tom Lamb at Drug Injury Watch)

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UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:

As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said.  [Emphasis added.]

(2/28/24)

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On October 5, 2023, Apellis Pharmaceuticals issued an update for its Syfovre investigation into retinal vasculitis cases involving patients who used Syfovre for geographic atrophy (GA). In what seems to be the latest Syfovre safety update, Apellis reported an increase in the number of Syfovre-associated retinal vasculitis cases, but Apellis did not provide any significant new information regarding an "explanation" as to how these Syfovre adverse reaction events happened.

In an earlier August 2023 Syfovre safety update, "Apellis Provides Updates on Injection Kits and Rare Safety Events with SYFOVRE® (pegcetacoplan injection)",  Appelis pointed to “internal structural variations” in a 19-gauge filter needle used to withdraw Syfovre from the vial for treatment use as possibly being part of the problem, but with this caveat:

A causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world.

Before we go further into what Apellis announced in its October 2023 Syfovre safety update we want to set the stage by listing our three previous Drug Injury Watch articles about these retinal vasculitis cases in Syfovre patients:

Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events -- Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues  [8/17/2023]

Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists -- A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation  [7/28/2023]

Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness -- American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre  [7/19/2023]

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With that background now available, we turn to the Syfovre safety update part of this October 5, 2023 company press release, "Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023":

• In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.
• Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis. 
• Of the confirmed retinal vasculitis events, six patients have recovered vision either fully or partially, three patients have severe vision impairment that is unlikely to be resolved, and one patient’s outcome is pending. Visual outcomes in both suspected events are pending.
• All suspected retinal vasculitis events reported to Apellis are independently evaluated and adjudicated by two external sources: a panel of four retina/uveitis experts and an independent reading center as well as Apellis’ internal safety and medical teams.

EndPoints News Senior Editor Amber Tong, in her August 23, 2023 article "Apellis' safety probe into eye drug unearths issues with injection kits, while side effects remain 'very rare'", summarized the earlier August 2023 Apellis Syfovre safety update as follows:

Apellis has found a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy treatment — and the injection kit, not the drug itself, may be to blame.

Following a comprehensive investigation, Apellis said it identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan). It did not find a causal relationship between those structural variations and the cases of retinal vasculitis reported during real-world use of Syfovre. But it is advising healthcare practitioners to stop using kits with the 19-gauge filter needle and switch to using those with the 18-gauge filter needle, which is used to withdraw the drug solution from the vial....

The update amounts to “the closest thing to an explanation,” wrote Stifel analyst Annabel Samimy in a note.

“Based on the findings from our investigation, we believe it is prudent that practitioners only use the kits with the 18-gauge filter needle, which are already in distribution. This recommendation is out of an abundance of caution as patient safety is our top priority,” Apellis chief medical officer Caroline Baumal said in a statement.

Apellis also reported its latest tally of retinal vasculitis: There are now eight confirmed cases in total, meaning one additional case compared to its last update in late July. On top of that, the company said there are two events of suspected retinal vasculitis that have not been confirmed.

Overall, in this apparent October 2023 Syfovre safety update, Apellis did report an increase in the number of Syfovre-associated retinal vasculitis cases, but Apellis did not provide any significant new information as regards an "explanation" -- something the Stifel analyst perhaps predicted accurately back in August.

We will look for some further explanation about how or why these Syfovre retinal vasculitis adverse reaction events happened in the next Apellis Syfovre safety update -- if there is one.

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Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023

Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In September 2023 the Ozempic (semaglutide) drug label was updated to inform doctors and patients that adverse reaction reports concerning ileus, a gastrointestinal disorder, have been received for semaglutide during the time since Ozempic was first approved by the FDA in 2017. This September 2023 Ozempic label change can be found in part "6.3 Postmarketing Experience" of the Ozempic Full Prescribing Information document ("Revised: 9/2023" version).

Ileus is a medical condition similar to intestinal obstruction but with some distinctions. Essentially, for ileus the bowel does not work correctly, but there is no structural problem causing it; while for intestinal obstruction there is a partial or complete blockage of the bowel.

From a Mayo Clinic website page titled "Intestinal obstruction":

Intestinal obstruction is a blockage that keeps food or liquid from passing through your small intestine or large intestine (colon)....

Intestinal pseudo-obstruction (paralytic ileus) can cause signs and symptoms of intestinal obstruction, but it doesn't involve a physical blockage. In paralytic ileus, muscle or nerve problems disrupt the normal coordinated muscle contractions of the intestines, slowing or stopping the movement of food and fluid through the digestive system.

Getting back to the September 2023 Ozempic label change adding the ileus adverse reaction reports, this September 28, 2023, FiercePharma article, "Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder", provides some contextual information:

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

One came last week, when the FDA revealed that it has updated the label for Novo’s Ozempic, warning of the potential of intestinal blockage.

The condition, known as ileus, can be life threatening and is already listed as a potential side effect on the labels of Eli Lilly’s diabetes drug Mounjaro and Novo’s weight-loss therapy Wegovy, which is the same formulation as Ozempic, just in a higher dose.

On the FDA’s Adverse Events Reporting System (FAERS) public dashboard, the agency has tracked 33 reports of ileus from GLP-1 users, with two deaths....

The risk of ileus was cited earlier this year by a group of Chinese scientists. They wrote that the use of GLP-1 drugs may cause continuous increases in intestinal length, causing it to “become as inelastic and fibrotic as a loose spring.” The possibility of having an intestinal blockage peaks after a year and a half of use, the researchers said, which is longer than the duration of most of the clinical studies involving GLP-1 therapies.

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And we learn about the number of Ozempic gastrointestinal side effects, including ileus cases, that have been reported to the FDA during the first 6 months of 2023 from this September 28, 2023 article, "FDA Adds New Warning for Ileus to Semaglutide (Ozempic) Label", published September 28, 2023, on the HCPLive® website:

According to the US FDA’s Adverse Events Reporting System (FAERS) public dashboard, there have been 2951 total cases of adverse events associated with use of Ozempic during 2023 as of June 30, 2023. The majority of these cases are gastrointestinal-related events, which account for 1274 of the 2951 total cases.

Within the FAERS public dashboard, there were 6 total cases of ileus reported with use of [Ozempic], with 2 resulting in hospitalization. Of note, the number of cases reported so far in 2023 is more than double the total number of cases reported in 2019.

We will watch for more significant developments concerning gastrointestinal conditions such as ileus associated with Ozempic, Rybelsus, and Wegovy, semaglutide-containing drugs from Novo Nordisk.

In the meanwhile, we continue to investigate drug injury lawsuits for people who used Ozempic, Rybelsus, or Wegovy and then were diagnosed with serious gastrointestinal side effects like gastroparesis, gastric stasis, or stomach paralysis.

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Severe Stomach Conditions in Patients Using Semaglutide Weight Loss Drugs From Novo Nordisk

Ozempic, Rybelsus, and Wegovy Use Might Cause Gastroparesis, Gastric Stasis, or Stomach Paralysis

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Semaglutide is the active ingredient in three Novo Nordisk drugs that are being used for weight loss purposes:

1. Ozempic, which was approved in 2017 by the FDA as a Type 2 diabetes treatment, such that Ozempic is being used "off-label" for weight loss;
2. Rybelsus, approved in 2019 as Type 2 diabetes treatment, is also being used "off-label" for weight loss; and,
3. Wegovy, which was approved in 2021 by the FDA as a treatment for adult obesity and "indicated" for weight loss (and, therefore, not "off-label").

In recent years we have seen an increasing number of adverse event reports for these Novo Nordisk semaglutide weight loss drugs that involve severe stomach conditions, including:

• Gastroparesis
• Gastric Stasis
• Stomach Paralysis

For a general medical definition of these semaglutide-related stomach conditions, we turn to a National Library Medicine webpage titled "Gastric Stasis":

Gastroparesis (gastric stasis) is derived from Greek words gastro/gaster or stomach, and paresis or partial paralysis. It is a clinical condition resulting from delayed gastric emptying in the absence of mechanical obstruction and is associated with upper gastrointestinal symptoms. Most common symptoms include nausea, vomiting, early satiety, postprandial fullness, upper abdominal pain, bloating, and weight loss. These symptoms can be severely disabling and can adversely impact the quality of life in patients suffering from this disorder.

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Given this explanation and description of these severe stomach conditions that have been linked to Ozempic, Rybelsus, and Wegovy, people experiencing gastroparesis or gastric stasis often go to the emergency department/emergency room (ER) of their local hospital, sometimes several different times, before finally being admitted to the hospital.

While an ER doctor may determine that a person using the semaglutide weight loss drug has developed severe stomach conditions and then orders hospital admission, the actual medical diagnosis of gastroparesis or gastric stasis is usually made by a gastroenterologist, also called a GI doctor.

Going back to the increasing number of adverse event reports for Ozempic, Rybelsus, and Wegovy that involve severe stomach conditions, drug injury lawsuits will likely filed against Novo Nordisk. These lawsuits would be based on the failure of Novo Nordisk to include an adequate warning in the drug labels for these semaglutide weight loss drugs about an increased risk of gastroparesis, gastric stasis, or stomach paralysis.

We are currently investigating Ozempic, Rybelsus, and Wegovy drug injury lawsuits for people diagnosed with gastroparesis, gastric stasis, or stomach paralysis, and hospitalized for one of those possible semaglutide-related stomach conditions.

If we can assist you or someone you know, you can contact me by email ([email protected]) or phone (800-426-9535).

Of course, we will continue to monitor the medical and regulatory realms for significant developments regarding severe stomach conditions involving the Novo Nordisk semaglutide weight loss drugs Ozempic, Rybelsus, and Wegovy.

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Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening

Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Ozempic has been approved by the FDA as a treatment for diabetes which is increasingly used "off-label" for weight loss purposes. Wegovy is a higher-dose version of Ozempic that is FDA-approved to treat obesity. Both of these relatively new drugs, from the pharmaceutical company Novo Nordisk, contain the active ingredient semaglutide. In the several years since being on the market, there have been an increasing number of so-called "semaglutide-related" gastroparesis, stomach paralysis, and intestinal blockage cases diagnosed in patients using Ozempic or Wegovy.

Related to this situation, due to a "Potential Signal of a Serious Risk / New Safety Information" about intestinal obstruction in patients using Ozempic and Wegovy -- as well as other drugs in the Glucagon-like peptide 1 (GLP-1) receptor agonists class of drugs -- the FDA is evaluating the need for regulatory action. See "April - June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)".

We point out that the current drug labels for Ozempic and Wegovy do not warn about gastroparesis, stomach paralysis, and intestinal blockages or obstructions being potential side effects of Ozempic and Wegovy. As a result, patients are likely unaware that they are at risk for developing one of these severe gastric side effects, which can require hospitalization and surgery to treat. Furthermore, gastroparesis is a long-term, chronic condition that can be irreversible even after a patient stops using Ozempic or Wegovy. Gastroparesis may also be called delayed gastric emptying.

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This failure to warn doctors about these potential serious stomach or intestinal side effects associated with Ozempic and Wegovy has resulted in drug injury lawsuits filed against Novo Nordisk on behalf of patients who have been diagnosed with gastroparesis, stomach paralysis, and intestinal blockages.

Of course, we will continue to monitor the medical, regulatory, and legal sectors for more information concerning these severe gastric side effects of Ozempic and Wegovy. And be assured we will report significant developments going forward here on Drug Injury Watch.

If we can be of assistance with a possible drug injury lawsuit involving "semaglutide-related" gastroparesis, stomach paralysis, intestinal blockage, or intestinal blockage diagnosed in a patient using Ozempic or Wegovy, please do not hesitate to contact us.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (Website content is written by Tom Lamb)

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