Drug Injury Watch

Do Andexxa Risks Outweigh Benefits Given Increased Rate of Thrombosis and Thrombosis-Related Deaths?

Issue to be Considered by FDA Advisory Committee on November 21, 2024, and Discussion May Lead to Andexxa Drug Recall

 

(Posted by Tom Lamb at Drug Injury Watch)

 

At its November 21, 2024 meeting, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will discuss whether Andexxa risks outweigh benefits. From the October 2024 FDA Briefing Document for that Andexxa Advisory Committee meeting comes this Draft Discussion Question:

ANNEXA-I demonstrated an increased incidence of thrombosis (15.1% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the [Andexxa (andexanet)] arm compared to the [usual care (UC)]. Are the serious risks of [Andexxa (andexanet)] acceptable in the indicated population and in the context of the benefit demonstrated in ANNEXA-I?

For some contextual information, we turn to this November 19, 2024 Endpoints News report "Ahead of adcomm, FDA raises safety questions for AstraZeneca’s reversal agent for life-threatening bleeds", by Zachary Brennan, Senior Editor:

[Andexxa (andexanet)], a recombinant modified human factor Xa protein, is for patients treated with [Xarelto (rivaroxaban)] or [Eliquis (apixaban)] when rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. That could include, for example, when a patient needed urgent surgery because of a medical emergency or accident.

Last year, AstraZeneca began plans to shift Andexxa to a full approval from its accelerated approval after halting its confirmatory trial early due to these efficacy findings.

But FDA explained how the confirmatory trial, known as ANNEXA-I, revealed “major safety findings” including a “doubling of the rate of thromboses and thrombosis related deaths at Day 30 in the [Andexxa (andexanet)] arm compared with” a standard of care clotting agent known as a prothrombin complex concentrate.

Of the 239 patients treated with [Andexxa (andexanet)], FDA said, 14.6% of patients suffered thrombotic events versus 6.9% in the standard of care arm.

Essentially, as regards the issue of whether Andexxa risks outweigh benefits, the FDA wants this Andexxa Advisory Committee to look into the increased rates of dangerous clotting and clotting-related deaths seen in the ANNEXA-I trial done for Andexxa, compared with a standard of care reversal agent.

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For more specificity, we return to the October 2024 FDA Briefing Document and go to the Topics for Discussion part:

4.1. Increased Risk of Thrombosis of Treatment with [Andexxa (andexanet)]

The rate of thrombotic events among patients treated with [Andexxa (andexanet)] is double the rate of those who were treated with [usual care (UC)]. Of patients treated with andexanet, 14.6% suffered [thrombotic events (TEs)] versus 6.9% in the [usual care (UC)] arm.

Thrombotic events in the [Andexxa (andexanet)] arm tended to occur earlier at median day 3.5, compared with median day 16 in the UC arm. Such early [thrombotic event (TE)] onset may preclude attempts at prophylactic anticoagulant resumption.

Of those patients who resumed prophylactic anticoagulation, 9.6% in the [Andexxa (andexanet)] arm and 5.5% in the UC arm developed TEs. More than half of the 35 patients experiencing a TE after [Andexxa (andexanet)] treatment had their first TE within 3 days of randomization, a period when anticoagulation is generally not feasible due to bleeding concerns, and therefore did not receive prophylactic anticoagulation....

Death rates were comparable between the treatment arms with 28.0% in the [Andexxa (andexanet)] group and 26.3% in the UC arm, however, deaths attributable to TEs were more twice as high in the [Andexxa (andexanet)] arm than in the UC arm.

Even before this Andexxa Advisory Committee meeting was convened, there was speculation that it might lead to an eventual Andexxa drug recall. For example, here is an article published November 20, 2024, by Pink Sheet, "AstraZeneca’s Andexxa Could Be Headed For Withdrawal After US FDA’s Negative Advisory Committee Preview":

AstraZeneca PLC’s Andexxa may face withdrawal after the US Food and Drug Administration raised concerns about its clinical efficacy, as well as serious safety events seen in the anticoagulant reversal agent’s confirmatory study in briefing documents ahead of a 21 November advisory committee.

We will continue to monitor this emerging drug safety issue of whether Andexxa risks outweigh benefits.

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Side Effects of Birth Control: Brain Tumors Related to Depo-Provera Contraceptive Injections

Intracranial Meningioma Risks Are Increased When Depo-Provera Was Used for More Than One Year

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A medical journal article published in March 2024 reported that Depo-Provera (medroxyprogesterone acetate) increased the risk of intracranial meningioma by 5.6 times if Depo-Provera was used as birth control for longer than a year.

The contraceptive injection Depo-Provera being linked to brain tumors in some women is a still emerging drug safety issue that has recently resulted in some drug injury lawsuits seeking legal compensation being filed against the responsible pharmaceutical companies.

Intracranial meningiomas are mostly non-cancerous or non-malignant tumors that grow in layers of tissue covering the brain and spinal cord. However, cancerous or malignant meningiomas account for 40% of cancers in the central nervous system.  Both of these forms of intracranial meningioma are potentially serious medical conditions.

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This March 2024 BMJ article, "Use of progestogens and the risk of intracranial meningioma: national case-control study", provides these details about the increased risk of intracranial meningioma associated with the use of Depo-Provera, a widely used injectable birth control or contraceptive product in the US and around the world.

• "Meningiomas account for 40% of primary tumours of the central nervous system. The incidence of meningioma in the United States is 9.5 per 100 000 person years. Meningiomas are mostly slow growing, histologically benign tumours but can nevertheless compress adjacent brain tissue and thus patients may require surgical decompression. The incidence of meningiomas increases with age, rising sharply after the age of 65 years. Conversely, meningiomas are rare before the age of 35." [Footnotes omitted.]
• An excess risk of meningioma (odds ratio 5.55 (2.27 to 13.56)) was associated with the use of Depo-Provera (medroxyprogesterone acetate).
• Meningiomas before age 45 years were rare (n=3/9) in cases of exposure to Depo-Provera (medroxyprogesterone acetate).

If you are interested in reviewing some general medical information about meningioma, we direct you to the Mayo Clinic's "Symptoms & causes" and "Diagnosis & treatment" web pages.

We point out that the current drug label information for Depo-Provera Contraceptive Injection (Depo-Provera CI), version "Revised: 7/2024", does not include any warning about an increased risk of intracranial meningioma.

For this reason, i.e., failure to warn, we are investigating cases of the contraceptive injection Depo-Provera being linked to brain tumors in some women as possible drug injury lawsuits against the responsible pharmaceutical companies.

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Plaintiffs Win the Latest Round in Long-Running Fosamax Femur Fracture Litigation

Federal Appeals Court Rejects Merck's Legal Defense of Federal Preemption in September 2024

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A federal appeals court ruled in September 2024 that more than 500 plaintiffs should have their Fosamax femur fracture drug injury lawsuits reinstated and sent back to the current judge presiding over the federal court Fosamax MDL litigation.

Specifically, the United States Court of Appeals for the Third Circuit issued this opinion, In re: Fosamax (alendronate sodium) Products Liability Litigation, No. 22-3412, (3d Cir. Sept. 20, 2024).

As a result of that September 20, 2024 ruling by a unanimous panel of the US Third Circuit appellate court, those femur fracture drug injury lawsuits pending against defendant Merck in the federal court Fosamax MDL litigation are going to U.S. District Judge Karen Williams for potential future trials.

For a summary of this long-running Fosamax femur fracture litigation as regards the legal defense of federal preemption we get the following information from a Reuters news report by Brendan Pierson, "Court revives more than 500 lawsuits over Fosamax femur fracture risk":

The federal litigation stretches back to 2008, and has now been dismissed and revived twice. All of those decisions have hinged on the issue of federal preemption - whether the federal law governing what pharmaceutical companies are required to put on drug labels overrides, or preempts, state law claims that the label fails to warn consumers.

Merck has argued that it does, saying that in 2009 it proposed adding a warning about femur fractures but was initially rejected by the FDA. The warning was eventually added in 2011.

Now-deceased U.S. District Judge Joel Pisano in Trenton, New Jersey, ruled in Merck's favor on the preemption issue in 2013, but the 3rd Circuit overturned that ruling in 2017, concluding that issue should have been decided by a jury.

The U.S. Supreme Court in 2019 ordered the issue reconsidered once again, saying it was a legal issue for a judge, not a jury.

In 2022, U.S. District Judge Freda Wolfson, who had taken over the case [but has since retired], again sided with Merck on preemption.

The 3rd Circuit on [September 20, 2024], however, again reversed. It said that, even though the FDA had not approved the specific warning proposed by Merck in 2009, it would not necessarily have rejected any warning about femur fractures.

While this recent Third Circuit ruling allows the plaintiffs who filed these federal court femur fracture lawsuits to get a jury trial in the future, there are several other possible courses this Fosamax litigation could take from here.

One possibility is that Merck could decide to settle this set of federal court Fosamax lawsuits or, perhaps, all of the remaining Fosamax femur fracture drug injury lawsuits. "About 3,115 lawsuits over Fosamax were pending against Merck in both federal and state courts around the country as of June 30", according to the above Reuters news report.

A second possibility, perhaps more likely given the history of this Fosamax femur fracture litigation, is that Merck will appeal this latest ruling on their legal defense of federal preemption issue to the US Third Circuit sitting en banc or even up to the US Supreme Court.

We will continue to monitor this long-running Fosamax femur fracture litigation and keep you informed of significant developments.

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Veozah Liver Injury Drug Safety Communication Issued by FDA in September 2024

August 2024 Veozah Drug Label Change Adds Warnings About Liver Toxicity and Abnormal Liver Tests

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On September 12, 2024, the FDA announced a warning about the rare occurrence of serious liver injury when a woman is using Veozah for hot flashes due to menopause. This Veozah liver injury FDA Drug Safety Communication instructed patients and doctors to stop Veozah if signs and symptoms of liver injury occur.

In more detail, from the "Additional Information for Patients" section of that September 2024 FDA Veozah liver injury document:

Stop taking Veozah immediately and contact your health professional who prescribed the medicine if you experience signs and symptoms that suggest liver problems. These may include feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of the eyes or skin, called jaundice; dark urine; swelling in the stomach or belly area, called the abdomen; or pain in the right upper abdomen. Stopping the medicine if there are signs and symptoms that suggest liver injury could prevent worsening liver injury and potentially return liver function to normal.

As background, Veozah (fezolinetant) was approved by the FDA in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause, or more exactly "for the treatment of moderate to severe vasomotor symptoms due to menopause".

That more precise information and the newly added Veozah liver injury warnings are included in the Veozah Prescribing Information document, or drug label, "Revised: 8/2024" version. 

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In particular, through an FDA Supplemental Approval letter sent to Astellas Pharma US, Inc., which is dated 8/31/2024, several new paragraphs were added to this important part of the Veozah drug label: 5 WARNINGS AND PRECAUTIONS, 5.1 Hepatic Transaminase Elevation and Hepatotoxicity.

There may be some women who were using Veozah and then diagnosed with a serious liver injury at some point between May 2023 to August 2024, the period when the additional information found in those new paragraphs was not in the Veozah drug label. For those women, there are possible drug injury lawsuits that would be filed against Astellas Pharma for failure to adequately warn about liver toxicity and abnormal liver tests associated with Veozah use.

We will continue to monitor developments regarding this new Veozah liver injury drug safety issue.

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Syfovre Injections Side Effects Legal Compensation Cases Being Filed for Patients

Drug Company Apellis Failed to Warn About Retinal Vasculitis Until a November 2023 Label Change

 

(Posted by Tom Lamb at Drug Injury Watch)

 

We are handling Syfovre injections side effects legal compensation cases being filed for patients The basis for these product liability personal injury lawsuits is the drug company Apellis failed to warn about retinal vasculitis until a November 2023 label change.

In more detail, Syfovre (pegcetacoplan) is an eye-injection drug for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) from Apellis Pharmaceuticals. The FDA approved it on February 17, 2023.

Syfovre injections side effects include occlusive retinal vasculitis, which is a type of eye inflammation that blocks blood flow to the retina, resulting in vision loss and potentially causing blindness. There have also been reported cases of non-occlusive retinal vasculitis and other types of eye inflammation.

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. This report revealed that at least 13 patients had Syfovre retinal-related vision loss in 2023.

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 0f 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.

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 injections side effects 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 earlier by Apellis Pharmaceuticals.

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Returning to the American Society of Retina Specialists (ASRS), we get the latest from this July 19, 2024 news report, "The Syfovre Balancing Act. The Retinal Vasculitis Risk Is Real But Research Also Points to Benefits | ASRS 2024":

Last year’s annual meeting of the American Society of Retina Specialists (ASRS) was rocked by news that a small but notable number of patients treated with Syfovre (pegacetacoplan), the first-ever, FDA-approved treatment for geographic atrophy, developed retinal vasculitis, a serious complication that can lead to severe, permanent vision loss. The ASRS Research and Safety in Therapeutics Committee provided an almost day-by-day timeline and details on what was then a handful of cases.

At this year’s ASRS meeting in Stockholm, Sweden, this week, Syfovre’s risks and benefits were still a featured topic but the sense of urgency mellowed into the calmer territory more typical of medical conferences: discrepant findings and differing emphasis on risk and benefits but also points of agreement.

The combined results of two real-world evidence studies presented Thursday put the risk of developing retinal vasculitis at about 1 in every 1,330 patients....

We have been following 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. These are the five most recent articles we have written about Syfovre injections side effects:

1. Syfovre Safety-Benefit Assessment by Europe's Drug Regulator Differs From FDA (6/28/2024)
2. Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss (4/24/2024)
3. Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient's First Syfovre Injection (3/6/2024)
4. Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
5. Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)

As stated at the beginning of this article, we are handling Syfovre injections side effects legal compensation cases being filed for patients as product liability personal injury lawsuits filed against the drug company Apellis. We have a free online Syfovre Case Evaluation for these Syfovre lawsuits, or you can call us toll-free at 800-426-9535.

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No Warnings About Blood Clots From Ozempic, Wegovy, and Rybelsus in Drug Labels

Growing Number of Pulmonary Embolism and DVT Cases Involving Semaglutide Reported by Patients

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Wegovy, Rybelsus, and Ozempic have been associated with an increased risk of blood clots that can lead to pulmonary embolism (sometimes called PE) and deep vein thrombosis (often called DVT). However, there are no warnings about blood clots from Ozempic, Wegovy, and Rybelsus in their current Prescribing Information document, commonly called the drug label.

Wegovy, Rybelsus, and Ozempic are drugs with semaglutide as their active ingredient. As we first reported in this February 2024 article, "'New' Blood Clots Side Effect of Semaglutide Weight Loss Drugs Like Ozempic: Deep Vein Thrombosis", it is the semaglutide that has been linked to blood clots:

Somewhat hidden in a relatively recent medical journal article is the mention of a blood clots side effect of semaglutide weight-loss drugs like Ozempic, deep vein thrombosis (DVT). Remarkably, medical researchers found that semaglutide increased the risk of deep vein thrombosis by 266% when doing a study to assess the risk of semaglutide in leading to various serious adverse events (SAEs) in patients with type 2 diabetes.

DVT and Pulmonary Embolism Involving Semaglutide Drugs

Here are some representative case reports of DVT and pulmonary embolism involving semaglutide drugs:

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.

 

Other Blood Clot-Related Conditions Involving Semaglutide Drugs

Here are some representative case reports of other blood clot conditions involving semaglutide drugs:

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.

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No Blood Clot Warnings for Ozempic, Wegovy, and Rybelsus

The current Prescribing Information documents, or drug labels, for Ozempic, Wegovy, and Rybelsus (accessed 7/18/24) do not include any blood clot warnings. As seen below, in the warnings section of those drug labels there is nothing about deep vein thrombosis (DVT), pulmonary embolism (PE), portal vein thrombosis (PVT), ischemic stroke, or any other blood clot-related side effects.

• Ozempic (Revised: 9/2023) [PDF]: 5 WARNINGS AND PRECAUTIONS  5.1 Risk of Thyroid C-Cel Tumors  5.2 Pancreatitis  5.3 Diabetic Retinopathy Complications  5.4 Never Share an OZEMPIC Pen Between Patients  5.5 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin  5.6 Acute Kidney Injury  5.7 Hypersensitivity  5.8 Acute Galbladder Disease
• Wegovy (Revised: 3/2024) [PDF]: 5 WARNINGS AND PRECAUTIONS  5.1 Risk of Thyroid C-Cel Tumors  5.2 Acute Pancreatitis  5.3 Acute Galbladder Disease  5.4 Hypoglycemia  5.5 Acute Kidney Injury  5.6 Hypersensitivity Reactions  5.7 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes  5.8 Heart Rate Increase  5.9 Suicidal Behavior and Ideation
• Rybelsus (Revised: 1/2024) [PDF]: 5 WARNINGS AND PRECAUTIONS  5.1 Risk of Thyroid C-Cel Tumors  5.2 Pancreatitis  5.3 Diabetic Retinopathy Complications  5.4 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin  5.5 Acute Kidney Injury  5.6 Hypersensitivity  5.7 Acute Galbladder Disease

 

We have been investigating possible Ozempic, Rybelsus, and Wegovy 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. One way to do this is to submit an online Case Evaluation Form.

Of course, we will continue to watch for developments concerning this relatively new drug safety issue of Wegovy, Rybelsus, and Ozempic being linked to blood clots.

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Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION

Nonarteritic Anterior Ischemic Optic Neuropathy (NAION), or "Eye Stroke", Can Cause Vision Loss

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Wegovy, Rybelsus, and Ozempic eye side effects are possible given the recent findings that the active ingredient of these three drugs semaglutide is associated with nonarteritic anterior ischemic optic neuropathy (NAION).

As background, NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma.

We begin our reporting on the new semaglutide side effects findings with 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.

After hearing anecdotes of patients on the diabetes and obesity drugs experiencing nonarteritic anterior ischemic optic neuropathy, or NAION, researchers at Massachusetts Eye and Ear analyzed data from a registry of patients at their institution to see if there was a broad trend....

In both the diabetes and obesity cohorts that got semaglutide, the researchers found that NAION cases occurred most frequently in the first year after the medications were prescribed.

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.

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The medical journal article that presented the new semaglutide eye side effects findings, "Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide", was published on July 3, 2024, by JAMA Ophthalmology, and begins with this Key Points section:

• Question  Are prescriptions for semaglutide associated with an increased risk of nonarteritic anterior ischemic optic neuropathy (NAION) in patients with type 2 diabetes or patients who are overweight or obese?
• Findings  This matched cohort study of 16 827 patients revealed higher risk of NAION in patients prescribed semaglutide compared with patients prescribed non–glucagon-like peptide receptor agonist medications for diabetes or obesity.
• Meaning  The findings suggest a potential risk of NAION associated with prescriptions for semaglutide, but future study is required to assess causality.

A good summary of these Wegovy, Rybelsus, and Ozempic (semaglutide) eye side effects findings 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), reported Joseph Rizzo III, MD, of Massachusetts Eye and Ear and Harvard Medical School in Boston, and colleagues.

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, they wrote in JAMA Ophthalmology.

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.

"Despite evidence of neuroprotective properties, expression of the GLP-1 receptor in the human optic nerve and GLP-1 [receptor agonist] RA-induced enhanced sympathetic nervous system activity might influence optic nerve head perfusion and potentially increase the risk of NAION," suggested Rizzo and co-authors.

We are interested in hearing from patients who developed NAION following the use of Ozempic, Wegovy, or Rybelsus. We point out that NAION is sometimes referred to more simply as an “eye stroke" and, as it is a form of "optic neuropathy" (an eye disease category), NAION may be noted only as optic neuropathy in the medical records.

Patients who have been diagnosed with semaglutide-related NAION and experienced blindness or vision loss may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk, the pharmaceutical company responsible for Ozempic, Wegovy, and Rybelsus.

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Syfovre Safety-Benefit Assessment by Europe's Drug Regulator Differs From FDA

EMA’s CHMP Does Not Approve Syfovre for a Second Time, Citing "significant risk of adverse events"

 

(Posted by Tom Lamb at Drug Injury Watch)

 

There seems to be some disagreement about the Syfovre safety-benefit assessment when it comes to the US FDA and its European counterpart, the European Medicines Agency (EMA).

In late June 2024, Europe’s drug regulator, the Committee for Medicinal Products for Human Use (CHMP), did not approve Syfovre for a second time, with Apellis Pharmaceuticals asserting it will continue its efforts to market Syfovre in Europe.

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.

In a release, Apellis noted that there were “multiple dissenting votes” by CHMP members to the opinion. The company added that it plans to seek a reexamination of the opinion, with a final decision expected in the fourth quarter of this year.

“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. The drug was approved by the FDA in February of 2023 and generated $275 million in sales last year despite early reports of inflammation for some users.

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For more detail, we get this information from the updated Syfovre (pegcetacoplan) page on the EMA's website (accessed 6/28/24):

The European Medicines Agency has recommended the refusal of the marketing authorisation for Syfovre, a medicine intended for the treatment of geographic atrophy caused by age-related macular degeneration (AMD)....

The Agency issued its opinion on 27 June 2024....

What were the main reasons for refusing the marketing authorisation?

Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients. 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, 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. Therefore, the Agency’s opinion was that a positive balance of benefits and risks of Syfovre in the treatment of geographic atrophy caused by AMD could not be established and it recommended refusing marketing authorisation.

As we have reported previously, Syfovre side effects include occlusive retinal vasculitis, which is 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.

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. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

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Wegovy, Rybelsus, and Ozempic Blood Clots Cases Are Not Part of Federal Court MDL at This Time

Semaglutide-related Side Effects Include Ischemic Stroke, Pulmonary Embolism, and Deep Vein Thrombosis

 

(Posted by Tom Lamb at Drug Injury Watch)

 

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UPDATE:  This excerpt is from an August 21, 2024, HarrisMartin article, "JPML Asked to Include Deep Vein Thrombosis Cases in GLP-1 RA MDL":

The Judicial Panel on Multidistrict Litigation has been asked to transfer lawsuits alleging deep vein thrombosis caused by glucagon-like peptide-1 receptor agonists such as Ozempic to the GLP-1 RA MDL.

In an Aug. 20 motion, plaintiff Darius Craig notes that in its February order creating the MDL, the JPML did not mention the injury of venous thromboembolism, and therefore plaintiffs who allege the drugs caused them such injuries have been inadvertently excluded from MDL 3094.

We will monitor this development regarding Wegovy, Rybelsus, and Ozempic blood clots cases.

(8/21/24)

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Wegovy, Rybelsus, and Ozempic are drugs with semaglutide as their active ingredient. Semaglutide is associated with a significantly increased risk of blood clots. Drug injury lawsuits filed for people 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. Wegovy, Rybelsus, and Ozempic blood clots cases are not part of that federal court MDL at this time.

In more detail, Wegovy, Rybelsus, and Ozempic have been associated with an increased risk of blood clots that can lead to ischemic strokes (which are strokes caused by blood clots), pulmonary embolism (sometimes called a PE), or deep vein thrombosis (often called a DVT). This is a drug safety issue that has been overshadowed by gastrointestinal and stomach problems linked to Wegovy, Rybelsus, and Ozempic.  We first wrote about this drug safety issue in this February 2024 article, "'New' Blood Clots Side Effect of Semaglutide Weight Loss Drugs Like Ozempic: Deep Vein Thrombosis".

Since then, 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. As seen below, those semaglutide blood clot cases would not be part of the federal court MDL that includes Wegovy, Rybelsus, and Ozempic lawsuits involving gastrointestinal and stomach problems.

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From the February 2024 Transfer Order for MDL No. 3094 (PDF document), we get the following information:

The scope of this MDL, should the Panel order centralization, is a primary point of contention among the parties. The actions on the motion are personal injury actions stemming from use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), medicines that are prescribed for, among other things, the treatment of type 2 diabetes and to help certain obese or overweight individuals lose excess weight.... This class of medications includes Ozempic, Wegovy, and Rybelsus, each of which contains semaglutide.... Movants seek to centralize actions involving plaintiffs who used any of these GLP-1 RA medications and in which plaintiffs suffered gastroparesis, ileus, intestinal obstruction or pseudo-obstruction, or other gastrointestinal injury....

All actions share common issues of fact regarding whether defendants knew or should have known that their GLP-1 RA products can cause gastroparesis and other gastrointestinal injuries, whether defendants adequately warned plaintiffs or their prescribing physicians about the alleged dangers of these products, and whether defendants made false, misleading, or incomplete representations regarding the safety of these products.

Drug injury lawsuits against Novo Nordisk involving a stroke, pulmonary embolism, or deep vein thrombosis when using Wegovy, Rybelsus, or Ozempic are somewhat similar to the federal court MDL lawsuits involving gastrointestinal and stomach problems to the extent that these three issues would be involved:

1. Whether Novo Nordisk knew or should have known that its semaglutide-containing drugs Wegovy, Rybelsus, and Ozempic can cause ischemic strokes, pulmonary embolism (PE), or deep vein thrombosis (DVT);
2. Whether Novo Nordisk adequately warned the patient who suffered a stroke, PE, or DVT -- or their prescribing doctor -- about the alleged increased risk of blood clots of Wegovy, Rybelsus, Ozempic; and,
3. Whether Novo Nordisk made false, misleading, or incomplete representations regarding the safety of Wegovy, Rybelsus, and Ozempic.

However, the Wegovy, Rybelsus, and Ozempic blood clots lawsuits would not be part of 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.

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.

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Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss

She Went to the Local ER With Loss of Vision 11 Days After Receiving an Intravitreal Syfovre (Pegcetacoplan) Injection

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In the March 2024 edition of the American Journal of Ophthalmology Case Reports medical journal, there is a Syfovre retinal vaso-occlusive vasculitis case report involving a 78-year old woman with vision loss that happened back in the first part of 2023. This article, "Retinal vasculitis following intravitreal pegcetacoplan administration", was initially submitted to that medical journal in July 2023 and first available online in January 2024.

From the Abstract for this relatively recent article about a Syfovre retinal vaso-occlusive vasculitis case:

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....

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We get additional details about this Syfovre retinal vaso-occlusive vasculitis case from the full-text article:

• "We present a case of [Syfovre (pegcetacoplan)] associated vaso-occlusive vasculitis atypically presenting with associated lid edema and conjunctivitis, and subsequently developing hyphema and vitreous hemorrhage."
• "Eleven days after her [first Syfovre (pegcetacoplan) injection], the patient presented to the ER with left eyelid edema, ocular discomfort and conjunctival injection. She also complained of headache and loss of vision."
• "Two days after the ER visit (thirteen days after receiving the [Syfovre (pegcetacoplan)] injection), the patient came for ophthalmologic evaluation. Visual acuity had decreased to 20/400 in the left eye."
• "Differential diagnosis included central retinal vein occlusion. However, the patient had no risk factors for central retinal vein occlusion such as diabetes or hypertension."
• "Hemorrhagic occlusive retinal vasculitis (HORV) was also included in the differential diagnosis."
• "Like the [Beovu (brolucizumab)] and hemorrhagic occlusive retinal vasculitis cases, this presentation most likely represents a delayed hypersensitivity reaction.... Unlike most of the [Beovu (brolucizumab)] associated vasculitis, in our case, there had been no intraocular injections prior to the administration of [Syfovre (pegcetacoplan)] and there was only a minimal anterior chamber reaction upon presentation."

From the Conclusion part of that March 2024 medical journal article about this Syfovre retinal vaso-occlusive vasculitis 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.

In connection with that last point, the November 2023 "Dear Doctor" letter about Syfovre from Apellis Pharmaceuticals, titled "SUBJECT: SYFOVRE® (pegcetacoplan injection), New Warnings and Precautions: Retinal Vasculitis and/or Retinal Vascular Occlusion", which had a "Prescriber Action" part.

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. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.

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