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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.
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.
To read more of this article, click below:
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.
To read more of this article, click below:
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:
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- 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.
To read more of this article, click below:
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]Syfovre Occlusive Retinal Vasculitis Cases Warning Letter July 2023
The American Society of Retinal Specialists (ASRS) issued a warning letter about the Syfovre occlusive retinal vasculitis cases in patients who used this injection eye drug. Syfovre is a 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.
This ASRS July 2023 letter about Syfovre occlusive retinal vasculitis cases pointed out that the vision loss symptoms began one to two weeks after a patient’s first Syfovre (pegcetacoplan) injection. The ASRS said there have been six reports of occlusive retinal vasculitis to date, as well as other reports of serious eye inflammation due to Syfovre injections.
To read more of this article, click below:
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 couple of years, our law firm handled Beovu lawsuits for vision loss, blindness, and other serious eye problems that were filed against Novartis, the manufacturer of Beovu.
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.
If you or someone you know has a possible Syfovre drug injury lawsuit, we encourage you to submit a Case Evaluation Form online.
[Read article in full at original source]Ozempic Gallbladder Cases: Gallbladder Disease and Gallbladder Removal
The use of Ozempic has been associated with gallbladder diseases such as gallstones (cholelithiasis) and inflammation of the gallbladder (cholecystitis). These Ozempic side effects can lead to gallbladder removal surgery (cholecystectomy). We are currently investigating certain Ozempic gallbladder cases as possible Ozempic drug injury lawsuits that would be filed against the responsible drug company, Novo Nordisk.
If you were prescribed Ozempic before April 2022 and had gallbladder removal surgery or were hospitalized for gallbladder disease, you should have an experienced drug injury lawyer review your possible Ozempic drug injury lawsuit.
To read more of this article, click below:
As background, an Ozempic gallbladder disease warning was the subject of a March 2022 Ozempic drug label change by Novo Nordisk.
While this March 2022 Ozempic gallbladder label change is a significant part of the legal analysis for a possible Ozempic gallbladder injury case, there are other important factors also. Figuring out if there might be a drug injury lawsuit to file against Novo Nordisk for your gallbladder disease is not as simple as whether your gallbladder diagnosis was made before or after that March 2022 “line-in-the-sand” date.
Two important factors — having to do with things other than when your gallbladder disease was first diagnosed or when you had gallbladder removal surgery — are:
- What is the date (month/year) when your doctor prescribed Ozempic?
- Was that Ozempic prescription for one month, a few months, or one year?
Of course, there are additional facts we would consider when investigating these Ozempic gallbladder cases as possible drug injury cases.
Generally, the legal basis for these Ozempic gallbladder cases is that Novo Nordisk failed to warn doctors and patients about the risks of gallbladder diseases in a timely manner. The contention is that, when one views the March 2022 Ozempic drug label change in the context of what they knew and when they knew it, this Ozempic gallbladder disease warning should have been added earlier. For example, there are several medical journal articles published before 2022 that report the use of GLP-1 receptor agonists like Ozempic has been associated with an increased risk of bile duct and gallbladder diseases such as gallstones.
If we can be of assistance to you or someone you know, we encourage you to submit a Case Evaluation Form online. Attorney Tom Lamb will do your Ozempic gallbladder case review and get back to you no later than the next business day.
Or call us toll-free at (800) 426-9535 to speak directly to attorney Tom Lamb about a possible Ozempic gallbladder case.
Either way, you will get Mr. Lamb’s impressions about your Ozempic case based on his more than 20 years of experience handling drug injury lawsuits.
[Read article in full at original source]Trulicity Double-Dose Recall in 2021 is Still a Drug Safety Issue in 2023
There was a relatively “low profile” Trulicity double-dose recall by Eli Lilly & Company back in 2021. Because there may still be thousands of double-dose Trulicity injectors in patients’ homes, we are concerned that this is an ongoing Trulicity drug safety issue. Here are seven reasons why:
To read more of this article, click below:
- Some Trulicity autoinjector devices labeled as 0.75 mg/0.5 mL, in fact, contain 1.5 mg/0.5 mL of product. As such, those Trulicity products can be viewed as “defective”.
- This 2021 Trulicity double-dose recall affects 119,539 boxes of Trulicity 0.75 mg/0.5 mL single-dose pens, four pens per box (NDC 0002-1433-80), from lot D396436C.
- When the FDA issued its Enforcement Report for that Trulicity double-dose recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.
- It was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.
- While the mislabeled Trulicity autoinjector devices were distributed throughout the United States, it appears that the associated Trulicity recall was only down to the retail level.
- It apparently took Eli Lilly at least two months, from mid-June 2021 to mid-August 2021 — to realize that this double-dose lot of Trulicity had been shipped to US pharmacies to dispense for use by patients.
- Even though the FDA designated this 2021 Trulicity double-dose recall as “Class II” — by definition, meaning that use of this product could cause temporary or medically reversible adverse health consequences — that FDA Class II designation also indicates there is a remote possibility of serious harm.
If you or someone you know may have suffered an adverse reaction as a result of using a Trulicity autoinjector device which was labeled as 0.75 mg but, later, it was determined the product contained 1.5 mg of Trulicity (a “double-dose”), we would be interested in hearing more about that event. It is possible that a Trulicity drug injury case could be filed against Eli Lilly, depending on the circumstances. For that purpose, one can submit a Case Evaluation Form to us for review.
[Read article in full at original source]Prolia Side Effect: Hypocalcemia in Patients on Dialysis
This relatively new Prolia side effect, hypocalcemia, first came to our attention in late 2022 with the release of this November 22, 2022 document, “FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)”.
From that November 2022 FDA Drug Safety Communication about the Prolia side effect hypocalcemia, we point out this FDA statement: “We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”
To read more of this article, click below:
As of now, it appears the FDA is still in the process of evaluating the osteoporosis drug Prolia (denosumab) to determine the need for regulatory action as regards this Prolia side effect hypocalcemia safety signal. This is according to this recent FDA information, “October – December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)” — which was labeled “Content current as of: 04/05/2023” when viewed earlier today, May 9, 2023.
We are waiting for the FDA’s determination on possible regulatory action as regards this Prolia side effect of hypocalcemia. Perhaps there will be stronger drug safety warnings in a revised Prolia drug label, for example.
[Read article in full at original source]All content by attorney Tom Lamb