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Side Effects Blog | Drug injury lawyer Tom Lamb keeps you informed about recent developments concerning prescription drug side effects and adverse reactions with his new articles.
Syfovre Eye Side Effects Cases Reported at Ophthalmology Meeting
A Syfovre eye side effects cases presentation was one of the most important at the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco in early November.
William J. Johnson, M.D., of the Wolfe Clinic in Iowa, reported on Syfovre eye side effects cases ranging from hemorrhagic occlusive vasculitis-type inflammation with continued blindness to uveitis to vision loss to symptomatic floaters.
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Dr. Johnson reported that “One of the patients experienced hemorrhagic occlusive vasculitis-type inflammation and continues to have no light perception — clinical terminology for blindness — in the treated eye”, according to this November 3, 2023, Managed Healthcare Executive news report, “Details on 5 Cases of Complications From Syfovre Injections | AAO 2023”.
We have been following this still-developing drug safety issue involving Syfovre eye side effects cases since July 2023. Our most recent Drug Injury Watch article, “Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further ‘Explanation'”, was posted last month, in mid-October 2023.
At present, we are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who developed occlusive retinal vasculitis, eye inflammation, vision loss, or blindness after receiving Syfovre injections.
[Read article in full at original source]Wegovy, Rybelsus, and Ozempic Linked to Gastroparesis by Medical Study
Patients who use drugs containing semaglutide are at an increased risk of gastroparesis, according to an October 2023 medical journal article about patients who used two different types of weight-loss drugs. The Novo Nordisk drugs Wegovy, Rybelsus, and Ozempic each have semaglutide as their active ingredient. Accordingly, Wegovy, Rybelsus, and Ozempic were linked to gastroparesis by the findings presented in this article. As regards possible gastroparesis drug injury lawsuits against Novo Nordisk, the better cases will involve non-diabetic patients who used Wegovy as intended for weight loss and people without diabetes who used Rybelsus or Ozempic “off-label” to lose weight. This is because the medical condition diabetes, itself, is a known cause of gastroparesis.
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The medical journal article we referred to above is titled “Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss”. This article was published on October 5, 2023, by the Journal of the American Medical Association (JAMA), and it presented the results of a recent medical study in which semaglutide drugs such as Wegovy, Rybelsus, and Ozempic were compared to Contrave, a drug which does not contain semaglutide. That medical study found the use of drugs containing semaglutide was associated with an increased risk of gastroparesis.
We are investigating possible gastroparesis drug injury lawsuits against Novo Nordisk for people who have not been diagnosed with diabetes and were using Rybelsus or Ozempic “off-label” as a weight-loss treatment. In addition, we are investigating gastroparesis cases involving Wegovy used by people who do not have diabetes.
Feel free to contact us about possible gastroparesis drug injury lawsuits involving Wegovy, Rybelsus, or Ozempic. We want to be clear that these cases would be filed against Novo Nordisk, the responsible drug company (and not your doctor).
[Read article in full at original source]Syfovre Retinal Vasculitis Cases Caused by Injection Kits With a 19-gauge Filter Needle?
In what seems to be the latest Syfovre safety update, in early October 2023 Apellis reported an increase in the number of Syfovre retinal vasculitis cases, but Apellis did not provide any significant new information regarding an “explanation” as to how these Syfovre adverse reaction events happened.
EndPoints News Senior Editor Amber Tong, in her August 23, 2023 article “Apellis’ safety probe into eye drug unearths issues with injection kits, while side effects remain ‘very rare'”, summarized the earlier August 2023 Apellis Syfovre safety update as follows:
To read more of this article, click below:
Apellis has found a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy treatment — and the injection kit, not the drug itself, may be to blame.
Following a comprehensive investigation, Apellis said it identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan). It did not find a causal relationship between those structural variations and the cases of retinal vasculitis reported during real-world use of Syfovre. But it is advising healthcare practitioners to stop using kits with the 19-gauge filter needle and switch to using those with the 18-gauge filter needle, which is used to withdraw the drug solution from the vial….
The update amounts to “the closest thing to an explanation,” wrote Stifel analyst Annabel Samimy in a note.
On October 5, 2023, Apellis Pharmaceuticals issued an update for its Syfovre investigation into retinal vasculitis cases involving patients who used Syfovre for geographic atrophy (GA). From one part of this company press release, “Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023”, we get the latest number of Syfovre-associated retinal vasculitis cases:
- In total, there have been 10 confirmed events of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected events.
- Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis.
In summary, there is an increase in the number of Syfovre retinal vasculitis cases, but we do not have any further “explanation” about how or why these Syfovre retinal vasculitis adverse reaction events happened.
[Read article in full at original source]Ozempic Intestinal Blockage and Obstruction Cases Increasing
The number of Ozempic intestinal blockage and obstruction cases, including ileus cases, that have been reported to the FDA during the first 6 months of 2023 was covered in this September 28, 2023 article, “FDA Adds New Warning for Ileus to Semaglutide (Ozempic) Label”, published September 28, 2023, on the HCPLive® website:
According to the US FDA’s Adverse Events Reporting System (FAERS) public dashboard, there have been 2951 total cases of adverse events associated with use of Ozempic during 2023 as of June 30, 2023. The majority of these cases are gastrointestinal-related events, which account for 1274 of the 2951 total cases.
Within the FAERS public dashboard, there were 6 total cases of ileus reported with use of [Ozempic], with 2 resulting in hospitalization. Of note, the number of cases reported so far in 2023 is more than double the total number of cases reported in 2019.
To read more of this article, click below:
In September 2023 the Ozempic (semaglutide) drug label was updated to inform doctors and patients that adverse reaction reports concerning ileus, a gastrointestinal disorder, have been received for semaglutide during the time since Ozempic was first approved by the FDA in 2017. This September 2023 Ozempic label change can be found in part “6.3 Postmarketing Experience” of the Ozempic Full Prescribing Information document (“Revised: 9/2023” version).
We will watch for more information on Ozempic intestinal blockage and obstruction cases, including ileus cases, in the medical literature and from the FDA as well as other drug regulators worldwide.
At the present time, we are investigating Ozempic intestinal blockage and obstruction cases where there has been a diagnosis of gastroparesis, gastric stasis, or stomach paralysis as possible drug injury lawsuits to be filed against Novo Nordisk, the responsible pharmaceutical company. We are also looking into similar cases involving Rybelsus or Wegovy, two other semaglutide drugs from Novo Nordisk. All three of these drugs, Ozempic, Rybelsus, and Wegovy, are being used more and more for weight-loss purposes, as has been reported by the mainstream media during this past year.
[Read article in full at original source]Ozempic, Rybelsus, and Wegovy Use Might Cause Gastroparesis, Gastric Stasis, or Stomach Paralysis
In recent years we have seen an increasing number of adverse event reports for three Novo Nordisk semaglutide-containing drugs — Ozempic, Rybelsus, and Wegovy — that involve severe stomach conditions, including:
- Gastroparesis
- Gastric Stasis
- Stomach Paralysis
The most common symptoms are nausea and vomiting, which can be severely disabling and can adversely impact the quality of life in patients suffering from these possible side effects of semaglutide-containing drugs such as Ozempic, Rybelsus, and Wegovy.
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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:
- Was actively using or recently stopped using Ozempic, Rybelsus, and Wegovy at the time they started to experience symptoms of these severe stomach conditions;
- Was diagnosed by a medical doctor with gastroparesis, gastric stasis, or stomach paralysis; and,
- 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.
[Read article in full at original source]Ozempic-Related Gastroparesis, Stomach Paralysis, Intestinal Blockages
In the several years since Ozempic was approved by the FDA, there have been adverse event reports of Ozempic-related gastroparesis, stomach paralysis, and intestinal blockage cases in patients using Ozempic. Gastroparesis may also be called delayed gastric emptying. Gastroparesis is a long-term, chronic condition that can be irreversible even after a patient stops using Ozempic.
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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.
[Read article in full at original source]Syfovre Eye Injections Adverse Reactions Update August 2023
We have some new information about Syfovre eye injections adverse reactions causing vision loss and blindness from Apellis Pharmaceuticals and the American Society of Retina Specialists (ASRS).
Apellis said that it has confirmed seven cases of Syfovre eye injections adverse reactions. More specifically, these Syfovre vision loss cases involve a type of eye inflammation called retinal vasculitis. Four Syfovre patients have developed occlusive retinal vasculitis, a possibly blinding condition in which blood flow to the retina is blocked.
The ASRS shared a timeline of events related to these cases of Syfovre eye injections adverse reactions, as outlined below:
To read more of this article, click below:
- 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.
[Read article in full at original source]Tepezza-Related Hearing Problems Warning July 2023
A warning about the risks of Tepezza-related hearing problems was finally added to the Tepezza drug label in July 2023. Some of the various hearing problems associated with Tepezza can cause hearing loss and can be permanent.
In more detail, in the current Tepezza Full Prescribing Information (Revised: July 2023) document, we point out this newly added subsection:
5.4 Hearing Impairment Including Hearing Loss
TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.
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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.
[Read article in full at original source]Syfovre Vision Loss Cases Reported In Patients After First Injection
Syfovre vision loss cases have been reported by patients after the first time they used this injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
In mid-July 2023 the American Society of Retinal Specialists (ASRS) issued a warning letter about Syfovre being associated with vision loss as well as some eye-related severe adverse reactions.
This still-developing Syfovre safety issue was next addressed by a so-called “Dear Doctor” letter that was sent to ophthalmologists by Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, later in July 2023, after the ASRS letter.
To read more of this article, click below:
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.
[Read article in full at original source]Ozempic Drug Safety Issues Update: July 2023 Edition
In this Ozempic drug safety issues update we report on suicidal thoughts, thyroid cancer, and gallbladder disease as being possible Ozempic side effects.
The European Medicines Agency (EMA) recently announced it has begun an investigation into Ozempic and suicidal thoughts as well as self-harm. From July 11, 2023 document “EMA statement on ongoing review of GLP-1 receptor agonists”, issued July 11, 2023:
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.
We turn next to another of the relatively new Ozempic drug safety issues, which is a possible association between Ozempic and thyroid cancer. From this June 22, 2023, Reuters news report, “Novo Nordisk says EMA raised safety signal on drugs including semaglutide”:
To read more of this article, click below:
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.
[Read article in full at original source]Collection of All Side Effects Blog Articles to Date
All content by attorney Tom Lamb