In a rush? You can use our Quick Contact Form to tell us the basic information about your case.
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.
Semaglutide-Related Blood Clots Cases: Ozempic, Wegovy, and Rybelsus
We have been receiving reports of people diagnosed with deep vein thrombosis (DVT), pulmonary embolism (PE), portal vein thrombosis (PVT), and ischemic stroke possibly due to semaglutide-related blood clots. Ozempic, Wegovy, and Rybelsus are drugs with semaglutide as their active ingredient.
Semaglutide-Related Blood Clots Cases: DVT and Pulmonary Embolism
Here are some reports of DVT and pulmonary embolism involving semaglutide drugs we have received in the past several months:
To read more of this article, click below:
Ozempic – Deep vein thrombosis (DVT) and pulmonary embolism were diagnosed in a 66-year-old woman who had been using Ozempic for 2 months.
Ozempic – Pulmonary embolism (PE) and DVT were diagnosed in a 53-year-old man who had been using Ozempic for 1 year.
Ozempic – Blood clots in both lungs, which is a bilateral pulmonary embolism, were diagnosed in a 46-year-old woman who had been using Ozempic for 2 months.
Rybelsus – DVT was diagnosed in a 62-year-old woman who had been using Rybelsus for 1 month.
Semaglutide-Related Blood Clots Cases: Other Medical Conditions
Here are some reports of other blood clot conditions involving semaglutide drugs we have received in the past several months:
Ozempic – Blood clot in the portal vein, or portal vein thrombosis (PVT), was diagnosed in a 44-year-old woman who had been using Ozempic for 2 weeks.
Wegovy – Ischemic stroke was diagnosed in a 45-year-old man who had been using Wegovy for 3 months.
We are investigating possible Rybelsus, Wegovy, and Ozempic drug injury lawsuits for people diagnosed with deep vein thrombosis (DVT), pulmonary embolism (PE), portal vein thrombosis (PVT), ischemic stroke, or any other blood clot-related side effects.
Let us know if we can assist you or someone you know with a Wegovy, Rybelsus, or Ozempic blood clot case. One way to do this is to submit an online Case Evaluation Form.
[Read the article in full at source]Ozempic Side Effects Include Eye Problems With Possible Vision Loss
In July 2024 we learned from a recent medical study that Ozempic side effects include eye problems with possible vision loss. More specifically, nonarteritic anterior ischemic optic neuropathy (NAION) has been linked to semaglutide — the active ingredient in Ozempic as well as Wegovy and Rybelsus. As such, this finding about the new NAION Ozempic eye problem side effect also applies to Wegovy and Rybelsus.
To read more of this article, click below:
The medical study that found the new Ozempic eye problems side effect was presented in this article, “Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide”, which was published on July 3, 2024, by the medical journal JAMA Ophthalmology.
We get an overview of the semaglutide – NAION medical study from this July 3, 2024, STAT news article, “Study links Ozempic to higher risk of eye condition that can cause vision loss”:
A new observational study on [July 3, 2024] reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision loss….
NAION, sometimes referred to as an “eye stroke,” occurs from a lack of sufficient blood flow to the optic nerve. It typically causes sudden vision loss and, in severe cases, can lead to blindness. There are currently no proven treatments for the condition.
Some information about the increased risk of these Wegovy, Rybelsus, and Ozempic eye problems side effects was provided in this July 3, 2024, MedPage Today article, “Semaglutide May Be Linked to Condition That Causes Blindness”:
Over a mean follow-up of nearly 3 years, patients with diabetes on semaglutide had more than a fourfold higher risk for developing nonarteritic anterior ischemic optic neuropathy (NAION) compared with patients not on a GLP-1 agonist (HR 4.28, 95% CI 1.62-11.29, P<0.001)….
Those prescribed semaglutide for overweight or obesity had an over sevenfold higher risk for NAION (HR 7.64, 95% CI 2.21-26.36, P<0.001), a significant cause of blindness…
Over 3 years, the cumulative incidence of NAION were 8.9% and 6.7% in the two semaglutide groups, respectively, versus 1.8% and 0.8% for the non-GLP-1 groups. [emphasis added]
Relevant to this recent finding that Ozempic side effects include eye problems with possible vision loss, we point out that in medical records, NAION is sometimes referred to more simply as an “eye stroke” and because it is a form of “optic neuropathy” (an eye disease category) NAION might be noted in short only as optic neuropathy.
Patients who developed NAION following the use of Ozempic, Wegovy, or Rybelsus may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk, the pharmaceutical company responsible for Ozempic, Wegovy, and Rybelsus.
[Read the article in full at source]Syfovre’s Risks Keep It Off The Market In Europe, Again, With June 2024 Decision
As we have been reporting since July 2023, Syfovre’s risks include serious eye side effects such as occlusive retinal vasculitis, a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and potentially causing blindness. There have also been cases of non-occlusive retinal vasculitis and other types of eye inflammation.
In late June 2024, Europe’s drug regulator did not approve Syfovre for a second time, meaning that Syfovre is still unavailable in Europe. In the US, Syfovre was approved by the FDA in February 2023.
To read more of this article, click below:
From this Fierce Pharma June 28, 2024 article, “EU’s drug regulator again rejects Apellis’ eye med….”, we get the latest on what is happening with Syfovre in Europe:
For the second time in six months, Europe’s Committee for Medicinal Products for Human Use (CHMP) has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy (GA) caused by age-related macular degeneration….
“Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP said. “It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies.”
“In terms of safety,” the CHMP continued, “regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision.”
In January of this year, the CHMP adopted its first negative opinion on Syfovre….
We have been monitoring this Syfovre drug safety issue since July 2023 on Drug Injury Watch, and these are the four most recent articles:
- Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss (4/24/2024)
- Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient’s First Syfovre Injection (3/6/2024)
- Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
- Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)
We continue to investigate possible Syfovre drug injury lawsuits for patients who developed retinal vasculitis or retinal vascular occlusion with resulting vision loss or blindness after their Syfovre injection.
[Read article in full at original source]Deep Vein Thrombosis When Using Wegovy, Rybelsus, or Ozempic
Drug injury lawsuits that might be filed against the pharmaceutical company Novo Nordisk involving a stroke, pulmonary embolism, or deep vein thrombosis when using Wegovy, Rybelsus, or Ozempic are somewhat like the federal court Wegovy/Rybelsus/Ozempic MDL lawsuits involving gastrointestinal and stomach problems because they would involve similar — but different — liability issues, such as:
To read more of this article, click below:
- Whether Novo Nordisk knew or should have known that its semaglutide-containing drugs Wegovy, Rybelsus, and Ozempic can cause ischemic strokes (which are strokes caused by blood clots), pulmonary embolism (PE), or deep vein thrombosis (DVT) — as opposed to gastroparesis, gastric stasis, stomach paralysis, and other semaglutide-related stomach conditions;
- Whether Novo Nordisk adequately warned the patient or their prescribing doctor about the alleged increased risk of blood clots of Wegovy, Rybelsus, Ozempic that can lead to a stroke, PE, or DVT; and,
- Whether Novo Nordisk made false, misleading, or incomplete representations regarding the drug safety of Wegovy, Rybelsus, and Ozempic.
In more detail, drug injury lawsuits for people using Wegovy, Rybelsus, or Ozempic diagnosed with gastroparesis, gastric stasis, stomach paralysis, and other semaglutide-related stomach conditions are in this federal court MDL: IN RE: GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS (GLP-1 RAS) PRODUCTS LIABILITY LITIGATION, MDL No. 3094.
However, drug injury lawsuits involving a stroke, pulmonary embolism, or deep vein thrombosis when using Wegovy, Rybelsus, or Ozempic would not be part of federal court MDL No. 3094 as currently configured in the February 2024 Transfer Order because that federal court MDL does not include stroke, PE, and DVT cases.
We have been investigating possible drug injury lawsuits against Novo Nordisk involving strokes caused by blood clots as well as PEs and DVTs in patients using Wegovy, Rybelsus, or Ozempic.
If we can assist you or someone you know, our Drug Injury Case Evaluation Form is available online, or you can call us at (800) 426-9535 to discuss a possible Wegovy, Rybelsus, or Ozempic case.
[Read article in full at original source]Syfovre: Loss of Vision 11 Days After Receiving Syfovre Injection
This blog post is about a Syfovre loss of vision case involving a 78-year-old woman with vision loss in the first part of 2023. It was reported in this medical journal article, “Retinal vasculitis following intravitreal pegcetacoplan administration”, which appeared in the March 2024 edition of the American Journal of Ophthalmology Case Reports.
From the Abstract for this relatively recent article about a Syfovre loss of vision case:
To read more of this article, click below:
Purpose: To describe a case of retinal vaso-occlusive vasculitis with associated lid edema and conjunctivitis following intravitreal [Syfovre (pegcetacoplan)] administration in a patient with geographic atrophy (GA).
Observation: A 78 year old Caucasian woman presented with complaints of lid edema, conjunctival injection, loss of vision, and mild ocular discomfort eleven days after receiving an intravitreal [Syfovre (pegcetacoplan)] injection in the left eye for geographic atrophy. Visual acuity on presentation was decreased to 20/400 from 20/200 previously in that eye….
From the Conclusion part of that March 2024 medical journal article about this Syfovre loss of vision case:
Being vigilant after the administration of intraocular pegcetacoplan and encouraging prompt evaluation of patients who present with new symptoms post injection is critical. Prompt treatment with topical, local, systemic corticosteroids is critical to control the inflammatory response to prevent further visual loss.
We are handling Syfovre drug injury lawsuits for people who developed retinal vasculitis or retinal vascular occlusion causing loss of vision or blindness after their Syfovre injection. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre — not the person’s eye doctor.
Perhaps you know a person who has had a loss of vision after getting a Syfovre injection in their eye. In that situation, this person must contact a lawyer to handle their Syfovre case to get legal compensation for the Syfovre drug injury they have suffered. Syfovre loss of vision lawsuits are being filed as individual cases. There will not be any Syfovre class actions for people who have experienced any loss of vision due to Syfovre.
[Read article in full at original source]Syfovre Eye Injury Cases Update One Year After First Reports: “Uncertain”
Beginning in April 2023, there have been reports of Syfovre eye injury cases, including retinal vasculitis resulting in significant vision loss. As of the beginning of April 2024, however, retina specialists seem to agree that both the etiology and the incidence rate of retinal vasculitis after Syfovre injections remain uncertain.
Put in more simple terms, the cause is still unknown and the number of patients remains unclear when it comes to retinal vasculitis after Syfovre injections.
To read more of this article, click below:
There are at least two difficulties when determining the number of Syfovre eye injury cases involving retinal vasculitis that have occurred to date:
- It is generally acknowledged that voluntary reporting of prescription drug adverse events is inherently subject to underreporting. Therefore, it is likely that some Syfovre retinal vasculitis cases have not been reported to the FDA, Apellis Pharmaceuticals, or retina specialists; and,
- Some Syfovre patients who developed “mild” retinal vasculitis might not have been identified because they did not receive a careful dilated fundus examination or fluorescein angiography (FA). As such, these patients who might have developed retinal vasculitis are not counted by the Syfovre injections incidence rate.
We are investigating Syfovre eye injury cases for patients who suffered vision loss due to retinal vasculitis after Syfovre injections. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, not the patients’ ophthalmologists or retina specialists.
We have been monitoring this Syfovre drug safety issue and continue to report significant developments on our Drug Injury Watch website. We list our three most recent articles if you want to learn more:
- Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient’s First Syfovre Injection (3/6/2024)
- Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
- Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)
If we can assist you or someone you know, our Syfovre Case Evaluation Form is available online, or you can call us at (800) 426-9535 to speak about a possible Syfovre eye injury case.
[Read article in full at original source]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]Collection of All Side Effects Blog Articles to Date
All content by attorney Tom Lamb