Drug Injury Watch

Ozempic: Reports of Gastrointestinal Disorder Ileus Added to Drug Label in September 2023

Paralytic Ileus, the Slowing of Food Movement Through Digestive System, is Similar to Intestinal Obstruction

 

(Posted by Tom Lamb at Drug Injury Watch)

 

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).

Ileus is a medical condition similar to intestinal obstruction but with some distinctions. Essentially, for ileus the bowel does not work correctly, but there is no structural problem causing it; while for intestinal obstruction there is a partial or complete blockage of the bowel.

From a Mayo Clinic website page titled "Intestinal obstruction":

Intestinal obstruction is a blockage that keeps food or liquid from passing through your small intestine or large intestine (colon)....

Intestinal pseudo-obstruction (paralytic ileus) can cause signs and symptoms of intestinal obstruction, but it doesn't involve a physical blockage. In paralytic ileus, muscle or nerve problems disrupt the normal coordinated muscle contractions of the intestines, slowing or stopping the movement of food and fluid through the digestive system.

Getting back to the September 2023 Ozempic label change adding the ileus adverse reaction reports, this September 28, 2023, FiercePharma article, "Novo Nordisk’s Ozempic gets FDA label update flagging risk of intestinal blockage disorder", provides some contextual information:

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

One came last week, when the FDA revealed that it has updated the label for Novo’s Ozempic, warning of the potential of intestinal blockage.

The condition, known as ileus, can be life threatening and is already listed as a potential side effect on the labels of Eli Lilly’s diabetes drug Mounjaro and Novo’s weight-loss therapy Wegovy, which is the same formulation as Ozempic, just in a higher dose.

On the FDA’s Adverse Events Reporting System (FAERS) public dashboard, the agency has tracked 33 reports of ileus from GLP-1 users, with two deaths....

The risk of ileus was cited earlier this year by a group of Chinese scientists. They wrote that the use of GLP-1 drugs may cause continuous increases in intestinal length, causing it to “become as inelastic and fibrotic as a loose spring.” The possibility of having an intestinal blockage peaks after a year and a half of use, the researchers said, which is longer than the duration of most of the clinical studies involving GLP-1 therapies.

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And we learn about the number of Ozempic gastrointestinal side effects, including ileus cases, that have been reported to the FDA during the first 6 months of 2023 from 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.

We will watch for more significant developments concerning gastrointestinal conditions such as ileus associated with Ozempic, Rybelsus, and Wegovy, semaglutide-containing drugs from Novo Nordisk.

In the meanwhile, we continue to investigate drug injury lawsuits for people who used Ozempic, Rybelsus, or Wegovy and then were diagnosed with serious gastrointestinal side effects like gastroparesis, gastric stasis, or stomach paralysis.

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Severe Stomach Conditions in Patients Using Semaglutide Weight Loss Drugs From Novo Nordisk

Ozempic, Rybelsus, and Wegovy Use Might Cause Gastroparesis, Gastric Stasis, or Stomach Paralysis

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Semaglutide is the active ingredient in three Novo Nordisk drugs that are being used for weight loss purposes:

1. Ozempic, which was approved in 2017 by the FDA as a Type 2 diabetes treatment, such that Ozempic is being used "off-label" for weight loss;
2. Rybelsus, approved in 2019 as Type 2 diabetes treatment, is also being used "off-label" for weight loss; and,
3. Wegovy, which was approved in 2021 by the FDA as a treatment for adult obesity and "indicated" for weight loss (and, therefore, not "off-label").

In recent years we have seen an increasing number of adverse event reports for these Novo Nordisk semaglutide weight loss drugs that involve severe stomach conditions, including:

• Gastroparesis
• Gastric Stasis
• Stomach Paralysis

For a general medical definition of these semaglutide-related stomach conditions, we turn to a National Library Medicine webpage titled "Gastric Stasis":

Gastroparesis (gastric stasis) is derived from Greek words gastro/gaster or stomach, and paresis or partial paralysis. It is a clinical condition resulting from delayed gastric emptying in the absence of mechanical obstruction and is associated with upper gastrointestinal symptoms. Most common symptoms include nausea, vomiting, early satiety, postprandial fullness, upper abdominal pain, bloating, and weight loss. These symptoms can be severely disabling and can adversely impact the quality of life in patients suffering from this disorder.

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Given this explanation and description of these severe stomach conditions that have been linked to Ozempic, Rybelsus, and Wegovy, people experiencing gastroparesis or gastric stasis 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 the semaglutide weight loss drug 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.

Going back to the increasing number of adverse event reports for Ozempic, Rybelsus, and Wegovy that involve severe stomach conditions, drug injury lawsuits will likely filed against Novo Nordisk. These lawsuits would be based on the failure of Novo Nordisk to include an adequate warning in the drug labels for these semaglutide weight loss drugs about an increased risk of gastroparesis, gastric stasis, or stomach paralysis.

We are currently investigating Ozempic, Rybelsus, and Wegovy drug injury lawsuits for people diagnosed with gastroparesis, gastric stasis, or stomach paralysis, and hospitalized for one of those possible semaglutide-related stomach conditions.

If we can assist you or someone you know, you can contact me by email ([email protected]) or phone (800-426-9535).

Of course, we will continue to monitor the medical and regulatory realms for significant developments regarding severe stomach conditions involving the Novo Nordisk semaglutide weight loss drugs Ozempic, Rybelsus, and Wegovy.

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Ozempic / Wegovy: Stomach And Intestinal Problems Can Be Irreversible, Life-threatening

Severe Gastric Side Effects Include Stomach Paralysis, Gastroparesis, And Intestinal Blockages

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Ozempic has been approved by the FDA as a treatment for diabetes which is increasingly used "off-label" for weight loss purposes. 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. In the several years since being on the market, there have been an increasing number of so-called "semaglutide-related" gastroparesis, stomach paralysis, and intestinal blockage cases diagnosed in patients using Ozempic or Wegovy.

Related to this situation, due to a "Potential Signal of a Serious Risk / New Safety Information" about intestinal obstruction in patients using Ozempic and Wegovy -- as well as other drugs in the Glucagon-like peptide 1 (GLP-1) receptor agonists class of drugs -- the FDA is evaluating the need for regulatory action. See "April - June 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)".

We point out that the current drug labels for Ozempic and Wegovy do not warn about gastroparesis, stomach paralysis, and intestinal blockages or obstructions being potential side effects of Ozempic and Wegovy. 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. Furthermore, gastroparesis is a long-term, chronic condition that can be irreversible even after a patient stops using Ozempic or Wegovy. Gastroparesis may also be called delayed gastric emptying.

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Ozempic / Wegovy

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This failure to warn doctors about these potential serious stomach or intestinal side effects associated with Ozempic and Wegovy has resulted in drug injury lawsuits filed against Novo Nordisk on behalf of patients who have been diagnosed with gastroparesis, stomach paralysis, and intestinal blockages.

Of course, we will continue to monitor the medical, regulatory, and legal sectors for more information concerning these severe gastric side effects of Ozempic and Wegovy. And be assured we will report significant developments going forward here on Drug Injury Watch.

If we can be of assistance with a possible drug injury lawsuit involving "semaglutide-related" gastroparesis, stomach paralysis, intestinal blockage, or intestinal blockage diagnosed in a patient using Ozempic or Wegovy, please do not hesitate to contact us.

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

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Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events

Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In late July 2023, we learned more about the Syfovre adverse reaction cases involving patient eye inflammation side effects such as retinal vasculitis. From Apellis Pharmaceuticals there was an update on the number of patients using Syfovre who have developed severe eye problems. And the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee provided a time of significant events to date.

We begin our continuing coverage of Syfovre adverse reaction cases with new details found in this July 31, 2023, BioPharma Dive news article, "Apellis faces safety doubts for fast-selling eye drug":

On [July 29, 2023], Apellis said that, since the February U.S. approval of its drug Syfovre in geographic atrophy, seven instances of a type of eye inflammation called retinal vasculitis have been confirmed by its internal safety committee and outside retinal specialists. Four were classified as “occlusive,” a possibly blinding condition in which blood flow to the retina is blocked.

Two cases of retinal vasculitis occurred in April, two in May and three in June, according to Apellis. The company is also evaluating, but hasn’t yet confirmed, one additional reported case....

Apellis’ figures differ slightly from those compiled so far by a safety committee advising the American Society of Retinal Specialists, which flagged the side effects to doctors earlier this month. Slides presented at the organization’s yearly meeting this weekend showed seven confirmed instances of occlusive retinal vasculitis, and another “suspected” case currently being reviewed....

Safety has been a concern before. The risk of side effects that were observed in testing, such as inflammation and the formation of new blood vessels in the eye, may grow with time. And though new data show the drug’s effects on eye lesions may also increase as patients receive more injections, Apellis hasn’t yet proven Syfovre can slow vision loss.

The retinal vasculitis cases in commercial use adds a new factor to doctors’ and patients’ risk-benefit calculations....

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We turn next to this July 31, 2023 report about the Syfovre adverse reaction cases, "Updated: Apellis vows to be transparent about eye inflammation tied to Syfovre, but questions remain", published by EndPointsNews:

In Apellis’ second quarter earnings call, which immediately pivoted to Syfovre, execs vowed to handle the situation “with the utmost integrity and transparency.” But they also conceded that much remains unknown.

“We do not know the cause yet. And realistically, we may never identify a singular cause,” Apellis CEO Cedric Francois said. “What we do know, however, is that these events have been very rare and sporadic, and that zero events were reported in our clinical studies.”

He added later that so far, the company has only been able to rule out drug product and manufacturing, and the rest remains to be researched....

Retinal vasculitis is a “severe inflammatory event that can potentially lead to significant vision loss,” according to CMO Caroline Baumal.

Of the seven cases confirmed by Apellis, two have recovered their vision “nearly back to baseline,” she said on the call. Two more have severe vision loss that she said is not likely to resolve — and the other three confirmed cases are evolving.

Syfovre won FDA approval in February. So far, Apellis has distributed 68,000 commercial vials — with an estimate of 60,000 administered to patients — and given 23,000 injections in clinical trials.

There were intraocular inflammation cases in those trials; when the retinal vasculitis reports first appeared, Apellis said, it looked back at those cases. Both internal and external experts confirmed none were vasculitis events.

Finally, we point out "ASRS ReST Committee sheds light on timeline of Syfovre inflammation reports", which appeared July 29, 2023, on the Healio Ophthalmology website, from which we get a timeline of significant events related to these Syfovre adverse reaction cases:

Andre J. Witkin, MD, FASRS, chair-elect of the ASRS Research and Safety in Therapeutics (ReST) Committee, shared a timeline of events related to the cases of inflammation and Syfovre (pegcetacoplan injection, Apellis Pharmaceuticals). He said that the first report of panuveitis with retinal occlusive vasculitis was received by ReST’s reporting system on July 3. ReST contacted Apellis to discuss safety concerns on July 5 and received reports of six additional cases over the next week.

On July 12, Witkin said, Apellis and the committee met to discuss severe intraocular inflammation and cases of vasculitis from post-marketing surveillance and clinical trials. ReST Committee members then unanimously agreed to prepare a member communication, which was discussed with Apellis. A draft of the communication was sent to the ASRS Executive Committee on July 14.

On July 15, members of the ASRS Executive Committee unanimously approved the communication, and a mock-up final member communication was reviewed and agreed to by Apellis. The member communication was released to ASRS members that same day.

On July 22, Apellis, the ASRS Executive Committee and ReST all agreed to hold this presentation at ASRS.

During the presentation, Witkin also shared details of the patient case reports.

We will continue to watch for further updates from Apellis and the ASRS about Syfovre adverse reaction cases involving retinal vasculitis and other eye inflammation side effects in patients who have received Syfovre injections.

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

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Tepezza Drug Label Change In July 2023 Adds Warning About Severe Hearing Impairment

Earlier Versions of Tepezza Prescribing Information Document Did Not Include Hearing Loss Side Effects

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Finally, in mid-July 2023, the Tepezza drug label now includes a warning about the risks of Tepezza-related hearing impairment.  As background, in January 2020 Tepezza received FDA approval for the treatment of thyroid eye disease (TED), which is also referred to as Graves' disease, Graves' eye disease (GED), Graves' orbitopathy, and Graves’ ophthalmopathy.

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.

Cases of Tepezza-related hearing impairment 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. For more about that situation, we refer you to our December 2022 post, "Tepezza Hearing Loss: Cases of This Drug Side Effect Reviewed in Various Medical Journal Articles", from which we get the following:

We recently wrote about Tepezza hearing loss cases in this October 2022 article, "Tepezza Hearing Side Effects Include Deafness, Sound Sensitivity, and Tinnitus, Resulting in Tepezza Drug Injury Lawsuits".  Therein we noted that case reports in medical journal articles show that Tepezza (teprotumumab) has been linked to hypoacusis, hyperacusis, autophony, and other hearing problems, which sometimes may be irreversible and permanent. We went on to point out that the (then) current Tepezza Full Prescribing Information (Revised: October 2021) document does not include any mention of hearing side effects in the "Warnings and Precautions" section nor in the "Adverse Reactions" section.  And that is still the situation with the updated Tepezza Full Prescribing Information (Revised: December 2022) document that came out today.

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We are investigating cases of Tepezza-related hearing impairment as possible Tepezza drug injury lawsuits.  In more detail, those Tepezza lawsuits involve cases where the patient, while using Tepezza, started to experience "new" hearing problems, such as:

• Hypoacusis: hearing loss ranging from impairment to deafness
• Sensorineural Hearing Loss (SNHL): type of hearing loss resulting from damaged hair cells in the inner ear
• Hyperacusis: sound or noise sensitivity that makes it hard to deal with everyday sounds
• Tinnitus: ringing in the ears in the absence of an external source
• Autophony: unusually loud hearing of one’s own voice, breathing, and other bodily sounds
• Eustachian Tube Dysfunction: sensations of ears being "plugged" or "full" resulting in muffled hearing

If you or someone you know experienced Tepezza-related hearing impairment and is interested in possibly getting legal compensation, we encourage you to submit a Drug Injury Case Evaluation Form online — it is free, confidential, and there is no obligation. These Tepezza drug injury cases would be filed against the pharmaceutical companies which are responsible for Tepezza, not your doctors.

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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)

 

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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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)

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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)

 

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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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)

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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

---

 

(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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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.

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Ozempic Gallbladder Injury Case Factors: When was the Ozempic Prescribed and For How Long?

March 2022 Ozempic Label Change About Risks of Gallbladder Disease is Just One Part of Legal Case Analysis

 

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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)

 

An Ozempic gallbladder disease warning was the subject of a March 2022 Ozempic drug label change by Novo Nordisk. Specifically, the following part was added to the Warnings and Precautions section of the Ozempic Prescribing Information document:

5.8 Acute Gallbladder Disease
Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

As background, cholelithiasis is more commonly referred to as gallstones, and cholecystitis is inflammation of the gallbladder. A person may require gallbladder removal surgery if other treatments do not relieve the inflammation and pain from gallstones. Cholecystectomy is the medical term for gallbladder removal surgery.

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.

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.

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Generally, the legal basis for an Ozempic gallbladder injury case against the responsible drug company is that Novo Nordisk failed to warn doctors and patients about the risks of gallbladder diseases in a timely manner. In more detail, 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.

Going from the law to medicine, Ozempic (semaglutide) is classified as a glucagon-like peptide-1 receptor agonist (GLP-1 RA). One's use of GLP-1 receptor agonists like Ozempic has been associated with an increased risk of bile duct and gallbladder diseases such as cholelithiasis.

The medical literature in support of why Novo Nordisk might of been "late" in warning about the risks of Ozempic-related gallbladder removal, for example, includes the following research:

1. "Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus" (2016)
2. "Safety issues with glucagon-like peptide-1 receptor agonists (pancreatitis, pancreatic cancer and cholelithiasis): Data from randomized controlled trials" (2017)
3. "Cholelithiasis in patients treated with Glucagon-Like Peptide-1 Receptor: An updated meta-analysis of randomized controlled trials" (2020)

As pointed out in the title of this article, for the legal case analysis of an Ozempic drug injury lawsuit there are two important factors having to do with things other than when your gallbladder disease was first diagnosed or when you had gallbladder removal surgery.

First, what is the date (month/year) when your doctor prescribed Ozempic?

Second, was that Ozempic prescription for one month, a few months, or one year?

Of course, there are other considerations that we would discuss if you contact us about a possible Ozempic drug injury case involving gallbladder disease.

If we can be of assistance to you or someone you know, we encourage you to submit a 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 about a possible Ozempic gallbladder injury 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.

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

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Trulicity Recall Due to Dose Labeling Error Back in 2021 May Still be Drug Safety Issue Today

Thousands of Trulicity Autoinjector Devices Labeled as 0.75 mg Might Contain 1.5 mg (i.e., a "double-dose")

 

(Posted by Tom Lamb at Drug Injury Watch)

 

A Trulicity recall back in August - September 2021 by Eli Lilly & Company was due to a dose labeling error involving a single lot of Trulicity (dulaglutide). That does not sound too alarming at first glance, but this incident becomes more concerning as a Trulicity drug safety issue when one takes a closer look.

First, 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".

Second, this 2021 Trulicity 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.

Third, when the FDA issued its Enforcement Report for that Trulicity recall, the document did not include the lot’s expiration date or where the defective Trulicity products were manufactured.

Fourth, it was announced later that the expiration date for this batch of double-dose Trulicity was January 27, 2023.

Fifth, 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.

Sixth, 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.

Lastly, even though the FDA designated this 2021 Trulicity 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.

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For more details, see these two source documents:

1.  Recall Enforcement Report for FDA recall D-0773-2021, which starts as follows:

Drug Recall Enforcement Report Class II voluntary initiated by Eli Lilly & Company, originally initiated on 08-19-2021 for the product Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 The product was recalled due to labeling: label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 ml actually contain 1.5 mg / 0.5 ml of product. The product was distributed nationwide and the recall is currently ongoing.

2.  California State Board of Pharmacy Trulicity recall alert, which provides an important update:

The Board of Pharmacy has received notice of the following product recall. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required.

NOTE: UPDATED EXPIRATION DATE

Description: TRULICITY 0.75MG/0.5ML PEN 4

Lot #: D396436C

Exp Date: 01/27/2023

NDC: 00002143380

UPC: 30002143380

Eli Lilly is recalling the above item/lot due to a dose labeling error. This recall is to the retail level. Affected product started shipping June 14, 2021.

Significantly, neither of those two source documents tells us how many of the double-dose Trulicity boxes were dispensed by pharmacies to patients rather than returned by pharmacies to Eli Lilly.

In addition, even though the expiration date for this recalled double-dose Trulicity is stated as "01/27/2023", patients often overlook this type of preventive information.

For example, we were contacted by a woman who reportedly used one of these recalled Trulicity products in mid-February 2023 and was subsequently hospitalized for three days for seizures that may have been related to using twice the amount of Trulicity that had been prescribed by her doctor.

Given that this 2021 Eli Lilly / FDA Trulicity recall was rather "low-profile", and 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.

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.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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