Drug Injury Watch

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

 

(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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As we reported here recently, in mid-July 2023 the American Society of Retinal Specialists (ASRS) issued a warning letter to its members about Syfovre being associated with some eye-related severe adverse reactions in patients who used this injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). For more about the first news of this Syfovre safety signal, we refer you to our July 19, 2023 article, "Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness".

Today we learned that soon after the July 2023 ASRS letter was sent out, a so-called "Dear Doctor" letter was sent to ophthalmologists by Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre.

From this July 28, 2023 press release from Spherix Global Insights, "First-to-Market Edge for Apellis’s Syfovre in Geographic Atrophy Diminished in the Face of an Unexpected Safety Signal", we get the following information:

According to the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee, ophthalmologists have reported cases of intraocular inflammation (IOI) following the administration of Syfovre. In addition to mild-moderate IOI, these reports also include severe IOI, retinal vasculitis, and occlusive retina vasculitis (six cases at the time of writing). These events occurred between 7 and 13 days after the initial dose of Syfovre was administered.  Apellis’s Medical Director, Caroline Baumal, issued a Dear Doctor Letter to the community shortly after ASRS provided the notification to prescribers. The Medical Director acknowledged the situation and assured ophthalmologists the FDA did not feel a label update was necessary at this time. Apellis’ outreach suggested there is suspicion that procedural changes between the clinical trials and real-world experience regarding injection techniques could have contributed to the increased incidence of IOI. As seen in the Beovu situation, Apellis, like Novartis, is working closely with the ReST Committee and several external specialists to continue to monitor the unfolding situation.

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Syfovre

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As we mentioned in our earlier article about this developing Syfovre safety signal situation, back in 2020 the ASRS alerted its member doctors about 14 cases of retinal vasculitis in patients after using Beovu, soon after the FDA approved that wet age-related macular degeneration drug from Novartis.

The analysts at Spherix Global Insights also saw a parallel between those Beovu side effects and this Syfovre safety signal:

For many who have been following the retina market, the news about the emerging safety signal associated with Apellis’ Syfovre in geographic atrophy (GA) feels very similar to the dashed expectations following the short-lived excitement for Novartis’ Beovu launch, an event the community is still reeling from. As of Q2 2023, 71% of the 100 ophthalmologists surveyed... report agree that based on the post-marketing safety issues with Beovu, they are more cautious when adopting newly launched products in the retina space....

While the full impact of this event has yet to completely materialize, early signs suggest at least some damage may already be done. Spherix conducted a pulse study with 51 ophthalmologists within the days following the breaking news of the Syfovre safety signal and found that nearly all surveyed physicians reported at least a moderate impact on their future prescribing of Syfovre as a result of the reported IOI, with two-thirds suggesting the event will have a significant impact on future prescribing of the treatment.

Our law firm handled Beovu lawsuits for patients who suffered vision loss, blindness, and other serious eye problems after getting Beovu infections. Those drug injury lawsuits were filed against Novartis, the manufacturer of Beovu.

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

We will continue to monitor this Syfovre safety signal situation and report further significant developments here.

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

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Attorney Tom Lamb does all case reviews)

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

 

(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 July 15, 2023, the American Society of Retinal Specialists (ASRS) issued this letter to its members, "ASRS Research and Safety in Therapeutics (REST) Committee Update on Adverse Events Reports Associated with Syfovre", warning about the Syfovre side effects eye inflammation and occlusive retinal vasculitis in patients who used this injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Occlusive retinal vasculitis is a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and could potentially cause blindness.

The ASRS July 2023 letter about these Syfovre side effects pointed out reported cases of eye inflammation and six reports of occlusive retinal vasculitis, noting that these vision problems began one to two weeks after a patient’s first Syfovre (pegcetacoplan) injection.

From this news report, "Apellis rocked by retinal vasculitis reports linked to Syfovre", published in the July 18, 2023 edition of ThePharmaLetter, we get these details about this new and still evolving Syfovre side effects situation:

According to Apellis, the company has reviewed the retinal vasculitis events with the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics Committee.

All the events were observed after the first injection of Syfovre, between seven to 13 days after drug administration, and with no specific lots implicated.

Upon review with external experts, two of the events were confirmed as occlusive, one was confirmed as non-occlusive, and the remaining three were undetermined based on limited information and lack of imaging. The cause of these events is unclear, and outcomes in these patients are still evolving....

In a filing to the US Securities and Exchange Commission, Apellis explained: “The reported vasculitis events have occurred at an estimated rate of approximately 1 in 10,000 injections, or 0.01% per injection. To date, approximately 60,000 vials of Syfovre have been distributed since the FDA approval on February 17, 2023, including commercial vials shipped to physician practices as well as sample vials delivered. In addition, there were zero events of retinal vasculitis reported in the clinical trials, reflecting more than 23,000 injections to date.”

Following the review with the FDA, no action is currently planned, but Apellis is continuing to conduct a thorough investigation of the events alongside the ReST Committee and several external specialists.

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Syfovre

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Back in 2020, the ASRS alerted its member doctors about 14 cases of retinal vasculitis in patients after using Beovu, soon after that wet age-related macular degeneration drug from Novartis was approved by the FDA.

During the past few years, our law firm has handled Beovu lawsuits that involved retinal vasculitis causing vision loss and blindness.  Those Beovu cases were filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to adequately warn doctors and patients about these Beovu side effects in a timely manner. We point out that the first three Beovu vision loss lawsuits filed in the US were for clients of our law firm.

Currently, we are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who have been diagnosed with retinal vasculitis or some other type of eye inflammation after receiving a Syfovre injection, causing vision loss or blindness.

If you or someone you know has a possible Syfovre drug injury lawsuit, we encourage you to submit a Syfovre Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb. Either way, you will get Mr. Lamb’s impressions about your Syfovre side effects case based on his more than 20 years of experience handling drug injury lawsuits.

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

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Attorney Tom Lamb does all case reviews)

Ozempic Side Effects: Gallbladder Diseases, Thyroid Cancer, And Suicidal Thoughts

Diabetes and Weight-Loss Drug Ozempic Getting Scrutiny From European Drug Safety Regulator EMA

 

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***See also: Ozempic Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages

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(Posted by Tom Lamb at Drug Injury Watch)

 

The popular diabetes and weight-loss drug Ozempic (semaglutide) has been linked to gallbladder diseases which may require gallbladder removal surgery. Other Ozempic side effects being investigated by the European Medicines Agency (EMA) are thyroid cancer and suicidal thoughts.

Starting with the gallbladder disease Ozempic side effects, we previously posted this Drug Injury Watch article, "Ozempic Gallbladder Injury Case Factors: When was the Ozempic Prescribed and For How Long?", which covered the March 2022 Ozempic label change that added warnings about the risks of gallbladder diseases.

Turning next to the possible association between Ozempic and thyroid cancer, we refer you to a June 22, 2023, Reuters news report, "Novo Nordisk says EMA raised safety signal on drugs including semaglutide", which includes this information:

A thyroid cancer safety signal was raised by the EU's drugs watchdog last month over several Novo Nordisk products including semaglutide, which is used in popular diabetes and obesity medicines Ozempic and Wegovy.

The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs, Novo Nordisk said. Such a signal from the EMA does not mean that the medicine is the cause of any reported adverse events.

"Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters....

Both EMA and its U.S. equivalent, the FDA, mention on Wegovy's label that semaglutide causes thyroid tumours in rodents but say the effects on humans are unknown. The FDA advises against taking Wegovy if the patient has a family history of thyroid cancer.

We point out that the current Ozempic Prescribing Information document (Revised: 03/2022) also has a warning about a risk of thyroid C-cell tumors.

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Ozempic

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Lastly, we take a look at the more recently announced EMA investigation into Ozempic and suicidal thoughts. We begin with this July 10, 2023, Reuters news report, "E.U. investigates Ozempic and weight-loss drug Saxenda after reports of suicidal thoughts", from which we get the following:

The European Medicines Agency is investigating Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Saxenda after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm....

The EMA’s investigation centers on medicines that contain either semaglutide or liraglutide. Novo’s obesity treatment Wegovy, for which demand has surged in the United States, contains semaglutide.

The review was announced weeks after the regulator raised a thyroid cancer safety signal, a means to monitor potentially adverse effects, on several of Novo’s products containing semaglutide.

Suicidal thoughts are not listed as a side effect in the E.U. product information for either drug.

In the United States, however, prescribing instructions for Wegovy recommend that patients are monitored for suicidal thoughts or behavior.

According to the U.S. Food and Drug Administration Adverse Event Reporting System Public Dashboard, there have been at least 60 reports of suicidal ideation since 2018 from patients on semaglutide or their health care providers.

For additional details we point out "Updated: European regulators investigating 150 reports of self-injury, suicide risk in patients taking Novo Nordisk meds for weight loss", which includes this July 2023 reporting by Endpoints News:

The European Medicines Agency is looking into about 150 reports of “possible cases of self-injury and suicidal thoughts” for weight loss patients who used Novo Nordisk’s semaglutide or liraglutide medicines.

The first three case reports were flagged by member agency Icelandic Medicines Agency, unveiled on Monday. The EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is now investigating.

“The case reports included two cases of suicidal thoughts, one following the use of Saxenda and one after Ozempic. One additional case reported thoughts of self-injury with Saxenda,” the EMA said via email to Endpoints News, before issuing an updated statement today.

The EMA said its review of Ozempic, Saxenda and Wegovy began on July 3 and has now been extended to include other GLP-1 receptor agonists. This review is expected to conclude in November 2023, the regulator said in a statement.

The EMA updated statement referenced above is "EMA statement on ongoing review of GLP-1 receptor agonists", issued July 11, 2023, and here is its introduction to this latest Ozempic drug safety issue:

EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists, including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). These medicines are used for weight loss and for treating type 2 diabetes.

At the present time, our law firm is reviewing Ozempic drug injury cases involving gallbladder diseases that lead to the need for gallbladder removal surgery. If we can be of assistance to you or someone you know, we encourage you to submit a Case Evaluation Form online. Or, if you prefer, call our toll-free number, (800) 426-9535,

As regards the possible Ozempic side effects of thyroid cancer and suicidal thoughts or self-injury, we will continue to monitor the two ongoing EMA investigations discussed in this article for further findings as regards these Ozempic drug safety issues.

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

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Attorney Tom Lamb does all case reviews)