Side Effects Blog

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.

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).

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.

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.

People experiencing gastroparesis, gastric stasis, or stomach paralysis often go to the emergency department/emergency room (ER) of their local hospital, sometimes several different times, before finally being admitted to the hospital.

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

We are currently investigating drug injury lawsuits for people diagnosed with possible side effects of semaglutide-containing drugs such as Ozempic, Rybelsus, and Wegovy.

In more detail, these drug injury lawsuits involve someone who:

1. Was actively using or recently stopped using Ozempic, Rybelsus, and Wegovy at the time they started to experience symptoms of these severe stomach conditions;
2. Was diagnosed by a medical doctor with gastroparesis, gastric stasis, or stomach paralysis; and,
3. Was hospitalized for those possible side effects of semaglutide-containing drugs such as Ozempic, Rybelsus, and Wegovy.

If we can assist you or someone you know, we encourage you to submit an online Case Evaluation Form. It is free, confidential, and there is no obligation. You will get a reply from us no later than the next business day.

In the alternative, you can email (TJL@LambLawOffice.com) or call (800-426-9535) attorney Tom Lamb to discuss the possible Ozempic, Rybelsus, or Wegovy drug injury lawsuit.

We point out that the current drug label for Ozempic does not warn about gastroparesis, stomach paralysis, and intestinal blockages or obstructions being potential side effects of Ozempic. As a result, patients are likely unaware that they are at risk for developing one of these severe gastric side effects, which can require hospitalization and surgery to treat.

Wegovy is a higher-dose version of Ozempic that is FDA-approved to treat obesity. Both of these relatively new drugs, from the pharmaceutical company Novo Nordisk, contain the active ingredient semaglutide. Wegovy has been linked to cases gastroparesis, stomach paralysis, and intestinal blockage, also. However, the current drug label for Wegovy (like Ozempic) does not warn about these severe gastric side effects.

We are investigating possible Wegovy and Ozempic drug injury lawsuits filed against Novo Nordisk based on this failure to warn doctors about those serious stomach or intestinal side effects. These Wegovy and Ozempic lawsuits involve gastroparesis, stomach paralysis, intestinal blockage, or intestinal blockage diagnosed in a patient while using Ozempic or Wegovy.

• July 3, 2023: The first report of panuveitis with retinal occlusive vasculitis was received by the ASRS Research and Safety in Therapeutics (ReST) Committee.
• July 5, 2023: ReST contacted Apellis to discuss safety concerns arising from this first Syfovre vision loss case.
• July 6-12, 2023: The ASRS received six additional reports of Syfovre eye injections adverse reactions in patients.
• July 12, 2023: Apellis and the ASRS Research and Safety in Therapeutics (ReST) Committee met to discuss severe intraocular inflammation and cases of vasculitis in patients who had received Syfovre eye injections.
• July 15, 2023: The ASRS Executive Committee unanimously approved the Syfovre safety concerns “communication”, which was agreed to by Apellis and sent to ASRS members that same day.

It has been reported by medical news sources that as of late July 2023, Apellis does not know the cause, yet, for these seven cases of Syfovre eye injections adverse reactions. Further, Apellis has said that so far the company has only been able to rule out drug product quality and manufacturing issues.

As such, other possible causes for these Syfovre vision loss cases involving retinal vasculitis remain to be researched.

We are investigating Syfovre vision loss cases as drug injury lawsuits against Apellis for patients who developed occlusive retinal vasculitis or eye inflammation after receiving a Syfovre eye injection.

Cases of Tepezza-related hearing problems had been reported well before this July 2023 Tepezza drug label change, and one wondered when there would finally be warnings about Tepezza hearing loss side effects.

We are investigating cases of Tepezza-related hearing problems as possible Tepezza drug injury lawsuits. Those Tepezza lawsuits involve cases where the patient, while using Tepezza, started to experience “new” hearing problems, such as:

• Hearing loss, ranging from impairment to deafness
• Sound or noise sensitivity that makes it hard to deal with everyday sounds
• Ringing in the ears in the absence of an external source, also known as Tinnitus
• Unusually loud hearing of one’s own voice, breathing, and other bodily sounds
• Sensations of ears being “plugged” or “full” resulting in muffled hearing

If you or someone you know experienced Tepezza-related hearing problems, we encourage you to submit a Drug Injury Case Evaluation Form online — it is free, confidential, and there is no obligation.

We point out that these Tepezza drug injury lawsuits would be filed against the pharmaceutical companies which are responsible for Tepezza, not your doctors.

From this July 28, 2023 item, “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.

We are investigating Syfovre vision loss cases that would be filed as drug injury lawsuits against Apellis for patients who developed occlusive retinal vasculitis or eye inflammation after receiving a Syfovre injection.

We will continue to monitor this Syfovre safety issue and report significant developments.

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.

Lastly, as regards Ozempic drug safety issues, this popular diabetes and weight-loss drug has been linked to gallbladder diseases which may require gallbladder removal surgery. We previously posted this article, “Ozempic Gallbladder Cases: Gallbladder Disease and Gallbladder Removal“, which covered the March 2022 Ozempic label change that added warnings about the risks of gallbladder diseases.

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.

We will continue to monitor the two ongoing EMA investigations into the other Ozempic drug safety issues, suicidal thoughts and thyroid cancer.