Side Effects Blog

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.

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.

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:

1. What is the date (month/year) when your doctor prescribed Ozempic?
2. 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.

1. 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”.
2. 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.
3. 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.
4. It was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.
5. 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.
6. 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.
7. 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.

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.