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Side Effects Blog | Drug injury lawyer Tom Lamb keeps you informed about recent developments concerning prescription drug side effects and adverse reactions with his new articles.
At Least 13 Patients Had Syfovre Retinal-Related Vision Loss in 2023
The Journal of VitreoRetinal Diseases (JVRD), which is the peer-reviewed journal of the American Society of Retina Specialists (ASRS), published a general report on Syfovre retinal-related vision loss, co-authored by members of the ASRS Research and Safety in Therapeutics (ReST) Committee. In summary, this report revealed that at least 13 patients had Syfovre retinal-related vision loss in 2023.
To read more of this article, click below:
That December 2023 JVRD ASRS ReST report article, “Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee“, considered 14 eyes of 13 patients who developed retinal vasculitis after their first Syfovre injection. For this set of Syfovre retinal-related vision loss cases, the ASRS ReST report provided these findings:
- 11 eyes were diagnosed as having developed occlusive vasculitis after a Syfovre injection;
- 6 of 14 eyes had significant vision loss, having lost more than 6 lines of vision; and,
- 2 eyes required enucleation, a surgical procedure that involves the removal of the entire eye.
And from the Abstract for that December 2023 JVRD article:
Conclusions: There is currently no known etiology for vasculitis in this series. Optimum treatment strategies remain unknown. Infectious etiologies should be considered, and corticosteroid treatments may hasten resolution of inflammatory findings. Continued treatment of affected patients with [Syfovre (pegcetacoplan)] should be avoided.
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 about the cause of Syfovre retinal-related vision loss:
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.
We are handling Syfovre drug injury lawsuits for patients who had Syfovre retinal-related vision loss. Those Syfovre lawsuits would be filed against Apellis Pharmaceuticals, not the patients’ ophthalmologists or retina specialists.
[Read article in full at original source]Wegovy / Rybelsus / Ozempic Deep Vein Thrombosis Side Effects
Adverse event reports that involve severe stomach conditions such as gastroparesis, gastric stasis, and stomach paralysis associated with Ozempic, Wegovy, and Rybelsus, the three popular GLP-1 receptor agonists containing semaglutide used as weight-loss drugs, are relatively well-known by now. In comparison, Wegovy, Rybelsus, and Ozempic deep vein thrombosis side effects have not received much attention.
Remarkably, medical researchers found that semaglutide — and therefore Wegovy, Rybelsus, and Ozempic — increased the risk of deep vein thrombosis (DVT) by 266% in patients with type 2 diabetes.
To read more of this article, click below:
The medical journal article that reported this semaglutide DVT side effect finding is “Comprehensive analysis of the safety of semaglutide in type 2 diabetes: a meta-analysis of the SUSTAIN and PIONEER trials”, published by the Endocrine Journal back in 2021.
Wegovy, Rybelsus, and Ozempic deep vein thrombosis side effects are particularly alarming since patients who have type 2 diabetes and who are obese are already at an increased risk of DVT. Significantly, the authors of this 2021 Endocrine Journal article suggested that Ozempic, Rybelsus, and Wegovy perhaps should be avoided by obese people with type 2 diabetes patients due to this semaglutide DVT side effect finding.
Here is some medical information about deep vein thrombosis (also known as deep venous thrombosis) from the Mayo Clinic, the U.S. National Institute of Health’s Medline Plus, and the Centers for Disease Control and Prevention.
We are investigating possible drug injury lawsuits involving Wegovy, Rybelsus, and Ozempic deep vein thrombosis side effects.
[Read article in full at original source]To start, we point out two medical journal articles that present a few weight-loss drugs gastroparesis side effects reports involving the use of semaglutide (Ozempic, Rybelsus, Wegovy) or dulaglutide (Trulicity):
- Tendency of Semaglutide to Induce Gastroparesis: A Case Report
- Medication-Induced Gastroparesis: A Case Report
Significantly, these medical journal articles provide some helpful information about symptoms and diagnosis of the weight-loss drugs gastroparesis side effects that have been associated with Ozempic, Rybelsus, Wegovy, and Trulicity.
To read more of this article, click below:
In the past six months on our Drug Injury Watch blog, we have written several times about the weight-loss drugs gastroparesis side effects:
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)
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, 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)
We are handling drug injury lawsuits for people who used Ozempic, Rybelsus, Wegovy, or Trulicity and then were diagnosed with the weight-loss drugs gastroparesis side effects.
[Read article in full at original source]A January 2024 Prolia drug label change that added a “Black-Box” warning for the “new” Prolia hypocalcemia side effect was announced through this 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).”
This Prolia drug label change followed the publication of a January 2024 JAMA Original Investigation article, “Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients”. In summary, it 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.
To read more of this article, click below:
To make clear the significance of these Prolia hypocalcemia side effect 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.
We will continue to monitor this still-developing Prolia drug safety issue involving severe hypocalcemia in Porlia patients with advanced chronic kidney disease (CKD).
Lastly, we have started to investigate possible drug injury lawsuits for patients with advanced chronic kidney disease (CKD) taking Prolia who developed this severe hypocalcemia side effect.
[Read the article in full at source]Syfovre Side Effects Issue Raised In December 2023 JAMA Viewpoint Piece
A December 2023 JAMA Ophthalmology Viewpoint piece about Syfovre side effects was reported on in a December 7, 2023, Managed Healthcare Executive article, “Independent Assessment of Syfovre Needed, Argues JAMA Ophthalmologist Viewpoint”:
To read more of this article, click below:
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.
This Viewpoint piece about Syfovre side effects, “Concerning Syfovre Approval for Geographic Atrophy”, was published December 7, 2023, online by JAMA Ophthalmology.
The results of the clinical trials 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. Whether those two phase 3 trials adequately addressed Syfovre side effects seems to be the issue raised by Dr. Schachar in his December 2023 Viewpoint piece.
[Read article in full at original source]New Syfovre Warnings for Retinal Vascular Occlusion and Retinal Vasculitis
A November 2023 label change added new Syfovre warnings for retinal vascular occlusion and retinal vasculitis cases associated with Syfovre injections. With these new Syfovre warnings, it now seems that the retinal vascular occlusion and retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as had been suggested by Apellis Pharmaceuticals.
Just a few months ago, in August 2023, Apellis suggested that an issue related to certain injection kits used for Syfovre may be a possible cause of the retinal vascular occlusion and retinal vasculitis cases associated with Syfovre use. And back then Apellis had urged doctors to switch to a different injection kit.
To read more of this article, click below:
We have been writing about Syfovre drug safety developments having to do with retinal vascular occlusion and retinal vasculitis cases as well as other eye-related Syfovre side effects since July 2023. Here is a list of our earlier Drug Injury Watch articles:
Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation [11/10/2023]
Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further “Explanation” [10/13/2023]
Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events [8/17/2023]
Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists [7/28/2023]
Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness [7/19/2023]
We are investigating Syfovre drug injury lawsuits that would be filed against Apellis Pharmaceuticals for patients involving retinal vascular occlusion and retinal vasculitis cases as well as other eye-related Syfovre side effects.
[Read article in full at original source]Syfovre Eye Side Effects Cases Reported at Ophthalmology Meeting
A Syfovre eye side effects cases presentation was one of the most important at the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco in early November.
William J. Johnson, M.D., of the Wolfe Clinic in Iowa, reported on Syfovre eye side effects cases ranging from hemorrhagic occlusive vasculitis-type inflammation with continued blindness to uveitis to vision loss to symptomatic floaters.
To read more of this article, click below:
Dr. Johnson reported that “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”, according to this November 3, 2023, Managed Healthcare Executive news report, “Details on 5 Cases of Complications From Syfovre Injections | AAO 2023”.
We have been following this still-developing drug safety issue involving Syfovre eye side effects cases since July 2023. Our most recent Drug Injury Watch 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.
[Read article in full at original source]Wegovy, Rybelsus, and Ozempic Linked to Gastroparesis by Medical Study
Patients who use drugs containing semaglutide are at an increased risk of gastroparesis, according to an October 2023 medical journal article about patients who used two different types of weight-loss drugs. The Novo Nordisk drugs Wegovy, Rybelsus, and Ozempic each have semaglutide as their active ingredient. Accordingly, Wegovy, Rybelsus, and Ozempic were linked to gastroparesis by the findings presented in this article. As regards possible gastroparesis drug injury lawsuits against Novo Nordisk, the better cases will involve non-diabetic patients who used Wegovy as intended for weight loss and people without diabetes who used Rybelsus or Ozempic “off-label” to lose weight. This is because the medical condition diabetes, itself, is a known cause of gastroparesis.
To read more of this article, click below:
The medical journal article we referred to above is titled “Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss”. This article was published on October 5, 2023, by the Journal of the American Medical Association (JAMA), and it presented the results of a recent medical study in which semaglutide drugs such as Wegovy, Rybelsus, and Ozempic were compared to Contrave, a drug which does not contain semaglutide. That medical study found the use of drugs containing semaglutide was associated with an increased risk of gastroparesis.
We are investigating possible gastroparesis drug injury lawsuits against Novo Nordisk for people who have not been diagnosed with diabetes and were using Rybelsus or Ozempic “off-label” as a weight-loss treatment. In addition, we are investigating gastroparesis cases involving Wegovy used by people who do not have diabetes.
Feel free to contact us about possible gastroparesis drug injury lawsuits involving Wegovy, Rybelsus, or Ozempic. We want to be clear that these cases would be filed against Novo Nordisk, the responsible drug company (and not your doctor).
[Read article in full at original source]Syfovre Retinal Vasculitis Cases Caused by Injection Kits With a 19-gauge Filter Needle?
In what seems to be the latest Syfovre safety update, in early October 2023 Apellis reported an increase in the number of Syfovre retinal vasculitis cases, but Apellis did not provide any significant new information regarding an “explanation” as to how these Syfovre adverse reaction events happened.
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:
To read more of this article, click below:
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.
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). From one part of this company press release, “Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023”, we get the latest number of Syfovre-associated retinal vasculitis cases:
- 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.
In summary, there is an increase in the number of Syfovre retinal vasculitis cases, but we do not have any further “explanation” about how or why these Syfovre retinal vasculitis adverse reaction events happened.
[Read article in full at original source]Ozempic Intestinal Blockage and Obstruction Cases Increasing
The number of Ozempic intestinal blockage and obstruction cases, including ileus cases, that have been reported to the FDA during the first 6 months of 2023 was covered in 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.
To read more of this article, click below:
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).
We will watch for more information on Ozempic intestinal blockage and obstruction cases, including ileus cases, in the medical literature and from the FDA as well as other drug regulators worldwide.
At the present time, we are investigating Ozempic intestinal blockage and obstruction cases where there has been a diagnosis of gastroparesis, gastric stasis, or stomach paralysis as possible drug injury lawsuits to be filed against Novo Nordisk, the responsible pharmaceutical company. We are also looking into similar cases involving Rybelsus or Wegovy, two other semaglutide drugs from Novo Nordisk. All three of these drugs, Ozempic, Rybelsus, and Wegovy, are being used more and more for weight-loss purposes, as has been reported by the mainstream media during this past year.
[Read article in full at original source]Collection of All Side Effects Blog Articles to Date
All content by attorney Tom Lamb