Drug Injury Watch

March 2025 Medical Article About Blindness or Vision Loss Linked to Ozempic and Rybelsus Use by Diabetes Patients

Discusses Timing for Increased Risk of Semaglutide-related Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) Side Effect

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On March 27, 2025, the JAMA Ophthalmology medical journal published a report about a recent medical study examining the relatively new drug safety issue of vision loss and blindness due to NAION linked to Ozempic and Rybelsus use by patients with type 2 diabetes. As stated in the Abstract for this article, "Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy Risk Among Patients With Diabetes", the Objective of that medical study was "To investigate the association between semaglutide use and the risk of NAION among patients with diabetes."

Here are earlier Drug Injury Watch articles about vision loss and blindness due to NAION linked to Ozempic and Rybelsus, as well as Wegovy, another semaglutide-containing drug:

• Ozempic Vision Problems From Semaglutide Apply to Wegovy and Rybelsus, Also (2/21/25)
• Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update (12/18/24)
• Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION (7/5/24)

We begin this new article about NAION linked to Ozempic and Rybelsus by presenting this summary from the Conclusions and Relevance part of the Abstract for the recent March 2025 JAMA Ophthalmology medical journal article:

Results of this cohort study suggest that semaglutide use was associated with an increased risk of NAION in patients with diabetes. However, the study’s retrospective design presents limitations, as it can only infer associations rather than establish causality; further studies are needed.

Going deeper into the full-text of this semaglutide-NAION medical study article, we point out the time relationship between Ozempic and Rybelsus use dates by patients with type 2 diabetes and the diagnosis dates for their NAION. From the Results section of that March 2025 JAMA Ophthalmology article, a part titled "Risk of NAION in Terms of Follow-Up Duration After Semaglutide Prescription" sets forth information about this timing aspect:

No increased risk was seen among patients with diabetes who received semaglutide at the 1-month (HR, 2.99; 95% CI, 0.31-28.75), 3-month (HR, 1.33; 95% CI, 0.30-5.93), 6-month (HR, 1.79; 95% CI, 0.60-5.35), and 1-year time points (HR, 1.94; 95% CI: 0.93-4.02) after the index date when compared with those receiving non–GLP-1 RA medication. However, among patients with diabetes, an increased risk for NAION was associated with use of semaglutide at the 2-year (HR, 2.39; 95% CI, 1.37-4.18), 3-year (HR, 2.44; 95% CI, 1.44-4.12), and 4-year (HR, 2.05; 95% CI, 1.26-3.34) time points from the index date compared with use of the non–GLP-1 RA medications (Table 1). Across the entire study duration, there was an increased risk for NAION associated with semaglutide use among patients with diabetes compared with non–GLP-1 RA users (HR, 2.22; 95% CI, 1.37-3.60). Kaplan-Meier curve analysis revealed that among patients with diabetes, there was an increased risk for NAION associated with semaglutide use compared with non–GLP-1 RA use at 2-year, 3-year, and 4-year follow-up from the index date (Figure 1 and Figure 2).

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This timing information for the semaglutide-related nonarteritic anterior ischemic optic neuropathy (NAION) side effect of Ozempic and Rybelsus use by diabetes patients suggests we may have a still-emerging drug injury lawsuit situation here. In more detail, given the growing blockbuster status of Ozempic and Rybelsus in combination with the apparent delay in onset of vision loss and blindness leading to a NAION diagnosis, it seems we are just at the start of hearing from patients who have suffered this eye-related side effect and who want to obtain legal compensation.

We have been investigating possible drug injury lawsuits for patients who developed vision loss and blindness due to NAION eye-related side effects of Ozempic and Rybelsus, two of three semaglutide-containing drugs from Novo Nordisk. (The other is Wegovy, approved by the FDA as a treatment for adult obesity and used for weight loss.)

Drug injury lawsuits involving Ozempic, Rybelsus, or Wegovy filed for patients with vision loss due to nonarteritic anterior ischemic optic neuropathy (NAION) would be against Novo Nordisk for its failure to warn about any eye problems, such as vision loss. This is because the current drug labels for Ozempic, Rybelsus, and Wegovy do not warn about any eye-related side effects, such as vision loss and blindness due to NAION.

In turn, as the current drug labels lack any safety warnings about an increased risk of eye-related side effects for Ozempic, Rybelsus, and Wegovy, these drug injury cases would not be filed against the patients’ prescribing doctors -- or their eye doctors treating the NAION.

Let us know if we can assist you or someone else with an Ozempic, Rybelsus, or Wegovy drug injury case concerning vision loss and blindness due to nonarteritic anterior ischemic optic neuropathy (NAION). One way to do this is to submit an online Case Evaluation Form.

The Brigham and Women's Hospital website provides basic medical information about non-arteritic anterior ischemic optic neuropathy (NAION).  People diagnosed with NAION often experience some degree of permanent vision impairment, which can be life-altering. 

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Ozempic Vision Problems From Semaglutide Apply to Wegovy and Rybelsus, Also

NAION Eye Side Effect Risk Increased With Semaglutide Drugs - Two Recent Medical Studies

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Two recent medical studies again link the eye side effect of non-arteritic anterior ischemic optic neuropathy (NAION) to semaglutide drugs, providing us with more information about Ozempic vision problems. That is significant because this is still an emerging drug safety issue, which extends to Wegovy and Rybelsus insofar as their active ingredient is semaglutide.

Our first article concerning Ozempic vision problems, "Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION", was posted in July 2024.  Our second article was posted several months later, "Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update".

In this third article about Ozempic vision problems, we will look at two of the most recent medical studies about semaglutide being associated with an increased risk of NAION. As a preview, the first study found that semaglutide was associated with a higher risk of NAION, having a hazard ratio of 2.19, while the second study "...confirms that use of semaglutide is associated to an increased risk of NAION but also that the excess absolute risk is low.”

The first study was reported in the medical journal International Journal of Retina and Vitreous, in this late 2024 article, "Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes".  From its Abstract we get this overview:

Background
Nonarteritic anterior ischemic optic neuropathy (NAION) is an untreatable condition often causing severe and irreversible visual loss in the affected eye. As it has recently been implied that the use of semaglutide associates with NAION, the aim of the present study was to evaluate this risk prospectively in all persons with type 2 diabetes (T2D) in Denmark.

Conclusions
During five years of observation of all persons with T2D in Denmark, use of once-weekly semaglutide independently more than doubled the risk of NAION. Given the irreversible nature of NAION, it is important to acknowledge this risk, and upcoming studies should aim to identify high-risk subgroups.

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The report for that second study is in preprint form and not yet published in a peer-reviewed journal, to our knowledge, but was posted December 11, 2024, online at medRxiv, which calls itself "The Preprint Server for Health Sciences".  From the Abstract for this piece, "Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study", we get the following:

Question  Is there an association between semaglutide use and risk of non-arteritic anterior ischemic optic neuropathy (NAION)?

Findings  In this cohort study conducted in Denmark and Norway, use of semaglutide was associated with an increased risk of NAION; the pooled hazard ratio was 2.81 (95% confidence interval (CI) 1.67 to 4.75) and the incidence rate difference (absolute risk increase) was +1.41 (95% CI +0.53 to +2.29) NAION events per 10,000 person-years. The finding was consistent across sensitivity and supplementary analysis.

The Brigham and Women's Hospital website provides some basic medical information about non-arteritic anterior ischemic optic neuropathy (NAION).

We are investigating drug injury lawsuits seeking legal compensation for people who received a diagnosis of NAION (non-arteritic anterior ischemic optic neuropathy) while using one of Novo Nordisk's semaglutide drugs, Ozempic, Wegovy, or Rybelsus.

People diagnosed with NAION often experience some degree of permanent vision impairment, which can be life-altering. We encourage you to complete our online Case Evaluation Form so that we can assist you or someone you know with a possible lawsuit involving Rybelsus, Wegovy, or Ozempic vision problems. This service is free and confidential, and there is no obligation. We will reply to you no later than the next business day.  Or you can call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Ozempic, Wegovy, or Rybelsus drug injury lawsuit.

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Meningioma Warning For Depo-Provera Recommended in Europe by Drug Regulator

Why Has This September 2024 European Medicines Agency (EMA) Action Not Been Followed by FDA in US?

 

(Posted by Tom Lamb at Drug Injury Watch)

 

One of the primary issues in the increasing number of Depo-Provera meningioma lawsuits will likely be why the drug label in the US still does not include a meningioma warning. Lawyers who are starting to prepare these cases for court trials in the future will probably explore the fact that the European Medicines Agency (EMA) recommended a meningioma warning for Depo-Provera (medroxyprogesterone acetate) back in September 2024.

The following information about the September 2024 drug regulator action on this Depo-Provera meningioma warning is found in this EMA document: "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2024."

We begin with this excerpt from the section titled "New recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate":

The PRAC has recommended measures to minimise the risk of meningioma, a type of brain tumour, with medicines containing medroxyprogesterone acetate [such as Depo-Provera]....

The committee’s recommendations followed a review of data from epidemiological studies, case studies from the medical literature and cases reported in the pharmacovigilance database of the European Union. These data show an increased risk of meningioma in people taking high doses of medroxyprogesterone acetate (injectables and ≥100 mg tablets) for several years. Although the relative risk of meningioma is significantly increased with the use of high-dose medroxyprogesterone acetate, the absolute risk is very small.

PRAC recommended that, in patients who have a meningioma or have had one in the past, medicines containing high-dose medroxyprogesterone acetate must not be used, unless medroxyprogesterone acetate is needed for the treatment of an oncological indication.

PRAC also recommended that patients taking high doses of medroxyprogesterone should be monitored for symptoms of meningioma, which can include change in vision, hearing loss or ringing in ears, loss of smell, headaches, memory loss, seizures and weakness in arms and legs....

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Next, from the section titled "Medroxyprogesterone: increased risk of meningioma with high doses and after prolonged use" in that same September 2024 EMA document:

The PRAC has agreed a direct healthcare professional communication (DHPC) to inform healthcare professionals of the increased risk of developing meningioma with high doses of medroxyprogesterone acetate (all injectable and ≥100 mg oral formulations), primarily after prolonged use (several years). The DHPC will highlight that medicines containing high doses of medroxyprogesterone acetate, when used for contraception or non-oncological indications, are contraindicated in patients with meningioma or with a history of meningioma. If a meningioma is diagnosed in a patient treated with high doses medroxyprogesterone acetate, treatment must be stopped.

One wonders why the FDA has not followed this EMA regulatory action since it was taken in September.

But the more important question in these Depo-Provera meningioma lawsuits will be why the drug companies responsible for Depo-Provera used by women in the US did not, and still do not, include any Depo-Provera meningioma warning in their drug label.

We will monitor the drug regulatory realm for further developments regarding the Depo-Provera drug label and watch the Depo-Provera meningioma lawsuits to learn more about this issue.

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Depo-Provera Drug Label Warnings in US Do Not Include Increased Risk of Intracranial Meningioma

While European Union (EU) and United Kingdom (UK) Drug Labels Have Warned About Meningioma for Many Years

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Drug injury lawsuits that involve the contraceptive injection Depo-Provera being linked to brain tumors in some women have been filed against the responsible pharmaceutical companies over the past several months. The basis for these legal cases is that the current US Depo-Provera drug label (version "Revised: 7/2024") does not include any warning about intracranial meningioma.

We touched upon this in our October 16, 2024 article, "Side Effects of Birth Control: Brain Tumors Related to Depo-Provera Contraceptive Injections".  However, in that earlier article, we did not report that the Depo-Provera drug label used in the European Union (EU) and the United Kingdom (UK) has warned about meningioma for many years.

Today we will examine this critical drug safety issue using some of the allegations found in various Complaints filed in courts around the country on behalf of women diagnosed with intracranial meningioma who are seeking legal compensation from the responsible pharmaceutical companies.

Essentially, these Depo-Provera drug injury lawsuits are based on the general contention that the pharmaceutical companies knew that Depo-Provera was unreasonably unsafe and unfit for use due to the "product defect" of an increased risk of intracranial meningioma associated with Depo-Provera, but failed to disclose and warn about meningioma to the regulatory agencies, the medical community, and women who received Depo-Provera injections -- at least here in the US.

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Here are some of the relevant allegations found in the Complaints filed for these Depo-Provera drug injury lawsuits:

• To date, the US Depo-Provera drug label does not mention the increased risk to patients of developing intracranial meningiomas, even though the European Union (EU) and the United Kingdom (UK) drug labels list meningioma under the “special warnings and precautions for use” section and advise patients to speak with their doctors before using Depo-Provera if they have a history of meningioma.
• Moreover, the Canadian drug label for Depo-Provera has listed “meningioma” among its “Post-Market Adverse Drug Reactions” since at least 2015.
• Several scientific studies have established that progesterone, its synthetic analog progestin, and Depo-Provera in particular, cause or substantially contribute to the development of intracranial meningioma, a type of brain tumor.
• The association between progesterone and meningioma has been known or knowable for decades, particularly for sophisticated pharmaceutical corporations like Defendants engaging in FDA-required post-market surveillance of their products for potential safety issues. That duty includes an obligation to keep current with emerging relevant literature and where appropriate, perform their own long-term studies and follow-up research.
• Since 1983 the medical and scientific communities have been aware of the high number of progesterone receptors on meningioma cells, especially relative to estrogen receptors.
• And since 1989 researchers have been aware of the relationship between progesterone-inhibiting agents and the growth rate of meningioma.
• Numerous studies published in the decades since have presented similar findings on the negative correlation between progesterone-inhibiting agents and meningioma.
• Defendant Pfizer has changed the Depo-Provera drug label in the EU and UK and potentially in other countries. Specifically, the EU drug label currently contains the following: "Meningiomas have been reported following long-term administration of progestogens, including medroxyprogesterone acetate. Depo-Provera should be discontinued if a meningioma is diagnosed. Caution is advised when recommending Depo-Provera to patients with a history of meningioma.”

As these allegations suggest, a primary focus of the US legal cases will be why the Depo-Provera drug label warnings in the US do not include the increased risk of intracranial meningioma that is included in the European Union (EU) and United Kingdom (UK) drug labels for Depo-Provera.

We are investigating Depo-Provera drug injury lawsuits for women who have been diagnosed with intracranial meningioma and are seeking legal compensation from the responsible pharmaceutical companies. We point out that these Depo-Provera cases will not be filed against the women's doctors who prescribed the Depo-Provera injections due to the failure to disclose and warn about meningioma here in the US.

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Possible Andexxa Recall After FDA Does Not Approve the Anticoagulant Reversal Drug in December 2024

AstraZeneca Says "while discussions with the FDA are ongoing, Andexxa will remain on the US market."

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In our November 21, 2024 article, "Do Andexxa Risks Outweigh Benefits Given Increased Rate of Thrombosis and Thrombosis-Related Deaths?", we previewed that discussions about this drug safety issue by an FDA Advisory Committee might lead to the withdrawal of Andexxa from the US market or, put otherwise, a possible Andexxa recall.

Now that this November 2024 Andexxa FDA Advisory Committee meeting has come and gone, we get an update on the current situation from a December 17, 2024, news report from FirstWord PHARMA, "Fate of AstraZeneca’s Andexxa unclear as FDA rejects full approval":

Less than a month after a bruising FDA advisory committee meeting, the agency has issued a complete response letter (CRL) regarding AstraZeneca's bid to convert its anticoagulant reversal drug Andexxa (andexanet alfa) from accelerated to full approval.

The fate of Andexxa is unclear at this stage; the FDA could seek withdrawal of the drug or ask for additional confirmatory data. AstraZeneca told FirstWord that "while discussions with the FDA are ongoing, Andexxa will remain on the US market."

Granted accelerated approval back in 2018 as an antidote for the reversal of Factor Xa inhibitors...

However, at last month's advisory meeting while discussing data from the ANNEXA-I confirmatory trial, panel members grappled with whether Andexxa's demonstrated benefits outweigh its risks. Ahead of the meeting, FDA reviewers highlighted "major safety findings," including a 14.6% thrombosis rate in the Andexxa arm of the study compared with 6.9% in the control group, along with higher thrombosis-related deaths.

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For more details about this possible Andexxa recall, we go to a December 13, 2024, news report, "AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response", written by Sarah Karlin-Smith for Pink Sheet:

AstraZeneca PLC’s anticoagulant reversal agent Andexxa (andexanet) will not convert to full approval, the company told the Pink Sheet after the US Food and Drug Administration issued a complete response letter [(CRL)] for the supplemental biologics license application.

The next steps for the drug following the CRL, which has not been publicly announced by the company, are unclear. Neither AstraZeneca nor FDA would provide much additional information about the product’s standing....

The agency could move to withdraw the drug from the market or ask the company to conduct additional studies to verify a favorable risk-benefit balance.

AstraZeneca told the Pink Sheet that the drug will remain on the US market while discussions with the agency about next steps continue. But the company would not comment on whether those discussions include potential new trials.

Andexxa is the only treatment currently indicated to reduce the effects of direct oral FXa inhibitors, Bristol-Myers Squibb Co./Pfizer Inc.’s Eliquis (apixaban) and Johnson & Johnson/Bayer AG’s Xarelto (rivaroxaban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

In summary, it seems the most one can say about this possible Andexxa recall is that it is unclear whether the FDA will seek withdrawal of this AstraZeneca anticoagulant reversal drug or request additional confirmatory data for Andexxa.

We will continue to watch for more developments concerning Andexxa, including whether its benefits outweigh its risks and this possible Andexxa recall.

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Novo Nordisk Semaglutide Drug Ozempic Linked to Vision Loss, Doubling the Risk: December 2024 Update

European Drug Regulators Are Investigating Semaglutide-Related NAION Cases Presented in Two Danish Studies

 

(Posted by Tom Lamb at Drug Injury Watch)

 

According to this December 18, 2024, Reuters news report, "Novo Nordisk's Ozempic faces EU review for potential eye disease connection", there is a significant development concerning semaglutide drugs like Ozempic linked to vision loss and blindness:

The European Union's drug regulator said it would assess two new Danish studies that link Novo Nordisk's popular diabetes drug Ozempic to a rare eye disease.

The studies published earlier this week had found Ozempic significantly increases the risk of type 2 diabetes patients developing NAION (non-arteritic anterior ischemic optic neuropathy), more than doubling the likelihood.  [emphasis added]

The European Medicines Agency (EMA) said late on [December 17, 2024] that the reviewed evidence from other research so far had not been strong enough to suggest a possible link between Ozempic and the eye disease but that the two Danish studies may hold new important information.

To provide context for this new European regulatory action on the drug safety issue of Ozempic linked to vision loss, we direct you to this December 16, 2024, Bloomberg article, "Ozempic Blinding Link in Study Prompts Agency to Seek Probe":

The Danish Medicines Agency said it would ask European authorities to review two new studies that point to a link between Novo Nordisk A/S’s blockbuster shot Ozempic and a rare form of vision loss.

The national regulator will call on the European Committee for the Evaluation of Adverse Reactions, or PRAC, to assess the Danish registry studies, the agency said [December 16, 2024].

A pair of large studies from the University of Southern Denmark “strengthen the suspicion” of a link between Ozempic and the rare eye condition, called NAION, the agency said.

Conducted independently, the studies both found that people who took Ozempic faced more than twice the risk of the eye condition, which can cause blindness. Both appear to confirm a link first suggested earlier this year in a Harvard University study....

One of the two studies to prompt the call for a review appeared last week on medRxiv, a website that posts studies before they’re reviewed by outside scientists....

The second study examined data from about 424,000 Danish diabetes patients, of whom a quarter received Ozempic, and has been accepted for publication in the International Journal of Retina and Vitreous.

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The first study mentioned above, "Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study", was posted online on December 11, 2024. From the Abstract for that Danish study:

• Importance  Recent findings have raised concerns about an association between semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), and non-arteritic anterior ischemic optic neuropathy (NAION).
• Objective  To further investigate the putative association between semaglutide use and NAION.
• Participants  New users of semaglutide and sodium-glucose co-transporter 2 inhibitors (SGLT-2is) during 2018-2022 (Norway) and 2018-2024 (Denmark).
• Results  We identified 44,517 eligible users of semaglutide for the management of type 2 diabetes in Denmark and 16,860 in Norway. In total, we observed 32 NAION events among semaglutide users (24 in Denmark and 8 in Norway). This yielded an unadjusted incidence rate of NAION of 2.19/10,000 person-years among Danish semaglutide initiators, compared to 1.18 among SGLT-2i initiators. The corresponding unadjusted incidence rates in Norway were 2.90 and 0.92. After adjustment, we obtained a pooled [hazard ratios (HR)] of 2.81 (95% CI 1.67 to 4.75)...
• Conclusions and Relevance  Our findings show an association between use of semaglutide for type 2 diabetes and risk of NAION. However, the absolute risk remains low.

In closing, from our earlier reporting on this drug safety issue of Ozempic linked to vision loss, "Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION":

We are interested in hearing from patients who developed [nonarteritic anterior ischemic optic neuropathy (NAION)] following the use of Ozempic, Wegovy, or Rybelsus. We point out that NAION is sometimes referred to more simply as an “eye stroke" and, as it is a form of "optic neuropathy" (an eye disease category), NAION may be noted only as optic neuropathy in the medical records.

Patients who have been diagnosed with semaglutide-related NAION and experienced blindness or vision loss may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk, the pharmaceutical company responsible for Ozempic, Wegovy, and Rybelsus.

We will continue to monitor the drug regulatory realm for more developments concerning semaglutide drugs like Ozempic linked to vision loss and blindness.

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Updated Ocaliva Liver Injury Warnings Are Issued By The FDA In December 2024

New Cases of Liver Transplants And Liver-Related Deaths Among Patients Who Did Not Have Cirrhosis

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In a December 12, 2024, Drug Safety Communication the FDA said it had recently found cases of Ocaliva liver injury among patients who did not yet have cirrhosis, or scarring of the liver, including reports of liver transplants and liver-related deaths.

From that December 2024 FDA document, "Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis", we get this contextual information:

We previously identified that [primary biliary cholangitis (PBC)] patients with advanced cirrhosis were at risk of serious liver injury when taking Ocaliva and updated the prescribing information to restrict its use in these patients. FDA’s review of this required clinical trial found that some cases of liver injury in patients without cirrhosis resulted in liver transplant...

FDA restricted the use of Ocaliva in patients who have PBC with advanced cirrhosis of the liver in 2021 because it can cause serious harm in those patients, adding a new Contraindication to the Ocaliva prescribing information and patient Medication Guide. However, our recent review of case reports submitted to FDA* found that some patients with PBC and advanced cirrhosis were still taking the medicine despite these restrictions.

For additional background, we refer you to our previous Drug Injury Watch article about Ocaliva liver injury, "FDA Safety Evaluation Finds Ocaliva-related Liver Injury in Primary Biliary Cholangitis (PBC) Patients with Advanced Cirrhosis", written in May 2021.

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Returning to the December 2024 FDA Drug Safety Communication about Ocaliva liver injury, we get these details about the recently found cases:

FDA evaluated liver safety in the postmarket clinical trial in patients who were appropriate for Ocaliva treatment based on the approved indication in the prescribing information. Among these patients, the risk of both liver transplant and death were higher in patients receiving Ocaliva compared with those receiving placebo. Specifically, among patients for whom Ocaliva was indicated, which were those with a lower risk of progression to liver transplant or death, 7 of 81 who received Ocaliva needed a liver transplant compared to 1 of 68 patients who received placebo. An additional four patients receiving Ocaliva died, compared to one receiving placebo. Analyses evaluating the risk of liver transplant and death resulted in a hazard ratio of 4.77 (95% confidence interval: 1.03, 22.09) for patients without advanced cirrhosis and not contraindicated from receiving the drug. [Footnote omitted.]

As before, we will continue to monitor the drug regulatory realm for more developments on Ocaliva liver injury.

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Do Andexxa Risks Outweigh Benefits Given Increased Rate of Thrombosis and Thrombosis-Related Deaths?

Issue to be Considered by FDA Advisory Committee on November 21, 2024, and Discussion May Lead to Andexxa Drug Recall

 

(Posted by Tom Lamb at Drug Injury Watch)

 

At its November 21, 2024 meeting, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will discuss whether Andexxa risks outweigh benefits. From the October 2024 FDA Briefing Document for that Andexxa Advisory Committee meeting comes this Draft Discussion Question:

ANNEXA-I demonstrated an increased incidence of thrombosis (15.1% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the [Andexxa (andexanet)] arm compared to the [usual care (UC)]. Are the serious risks of [Andexxa (andexanet)] acceptable in the indicated population and in the context of the benefit demonstrated in ANNEXA-I?

For some contextual information, we turn to this November 19, 2024 Endpoints News report "Ahead of adcomm, FDA raises safety questions for AstraZeneca’s reversal agent for life-threatening bleeds", by Zachary Brennan, Senior Editor:

[Andexxa (andexanet)], a recombinant modified human factor Xa protein, is for patients treated with [Xarelto (rivaroxaban)] or [Eliquis (apixaban)] when rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding. That could include, for example, when a patient needed urgent surgery because of a medical emergency or accident.

Last year, AstraZeneca began plans to shift Andexxa to a full approval from its accelerated approval after halting its confirmatory trial early due to these efficacy findings.

But FDA explained how the confirmatory trial, known as ANNEXA-I, revealed “major safety findings” including a “doubling of the rate of thromboses and thrombosis related deaths at Day 30 in the [Andexxa (andexanet)] arm compared with” a standard of care clotting agent known as a prothrombin complex concentrate.

Of the 239 patients treated with [Andexxa (andexanet)], FDA said, 14.6% of patients suffered thrombotic events versus 6.9% in the standard of care arm.

Essentially, as regards the issue of whether Andexxa risks outweigh benefits, the FDA wants this Andexxa Advisory Committee to look into the increased rates of dangerous clotting and clotting-related deaths seen in the ANNEXA-I trial done for Andexxa, compared with a standard of care reversal agent.

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For more specificity, we return to the October 2024 FDA Briefing Document and go to the Topics for Discussion part:

4.1. Increased Risk of Thrombosis of Treatment with [Andexxa (andexanet)]

The rate of thrombotic events among patients treated with [Andexxa (andexanet)] is double the rate of those who were treated with [usual care (UC)]. Of patients treated with andexanet, 14.6% suffered [thrombotic events (TEs)] versus 6.9% in the [usual care (UC)] arm.

Thrombotic events in the [Andexxa (andexanet)] arm tended to occur earlier at median day 3.5, compared with median day 16 in the UC arm. Such early [thrombotic event (TE)] onset may preclude attempts at prophylactic anticoagulant resumption.

Of those patients who resumed prophylactic anticoagulation, 9.6% in the [Andexxa (andexanet)] arm and 5.5% in the UC arm developed TEs. More than half of the 35 patients experiencing a TE after [Andexxa (andexanet)] treatment had their first TE within 3 days of randomization, a period when anticoagulation is generally not feasible due to bleeding concerns, and therefore did not receive prophylactic anticoagulation....

Death rates were comparable between the treatment arms with 28.0% in the [Andexxa (andexanet)] group and 26.3% in the UC arm, however, deaths attributable to TEs were more twice as high in the [Andexxa (andexanet)] arm than in the UC arm.

Even before this Andexxa Advisory Committee meeting was convened, there was speculation that it might lead to an eventual Andexxa drug recall. For example, here is an article published November 20, 2024, by Pink Sheet, "AstraZeneca’s Andexxa Could Be Headed For Withdrawal After US FDA’s Negative Advisory Committee Preview":

AstraZeneca PLC’s Andexxa may face withdrawal after the US Food and Drug Administration raised concerns about its clinical efficacy, as well as serious safety events seen in the anticoagulant reversal agent’s confirmatory study in briefing documents ahead of a 21 November advisory committee.

We will continue to monitor this emerging drug safety issue of whether Andexxa risks outweigh benefits.

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Side Effects of Birth Control: Brain Tumors Related to Depo-Provera Contraceptive Injections

Intracranial Meningioma Risks Are Increased When Depo-Provera Was Used for More Than One Year

 

(Posted by Tom Lamb at Drug Injury Watch)

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See also: "Depo-Provera Drug Label Warnings in US Do Not Include Increased Risk of Intracranial Meningioma -- While European Union (EU) and United Kingdom (UK) Drug Labels Have Warned About Meningioma for Many Years" (1/30/25)

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A medical journal article published in March 2024 reported that Depo-Provera (medroxyprogesterone acetate) increased the risk of intracranial meningioma by 5.6 times if Depo-Provera was used as birth control for longer than a year.

The contraceptive injection Depo-Provera being linked to brain tumors in some women is a still emerging drug safety issue that has recently resulted in some drug injury lawsuits seeking legal compensation being filed against the responsible pharmaceutical companies.

Intracranial meningiomas are mostly non-cancerous or non-malignant tumors that grow in layers of tissue covering the brain and spinal cord. However, cancerous or malignant meningiomas account for 40% of cancers in the central nervous system.  Both of these forms of intracranial meningioma are potentially serious medical conditions.

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This March 2024 BMJ article, "Use of progestogens and the risk of intracranial meningioma: national case-control study", provides these details about the increased risk of intracranial meningioma associated with the use of Depo-Provera, a widely used injectable birth control or contraceptive product in the US and around the world.

• "Meningiomas account for 40% of primary tumours of the central nervous system. The incidence of meningioma in the United States is 9.5 per 100 000 person years. Meningiomas are mostly slow growing, histologically benign tumours but can nevertheless compress adjacent brain tissue and thus patients may require surgical decompression. The incidence of meningiomas increases with age, rising sharply after the age of 65 years. Conversely, meningiomas are rare before the age of 35." [Footnotes omitted.]
• An excess risk of meningioma (odds ratio 5.55 (2.27 to 13.56)) was associated with the use of Depo-Provera (medroxyprogesterone acetate).
• Meningiomas before age 45 years were rare (n=3/9) in cases of exposure to Depo-Provera (medroxyprogesterone acetate).

If you are interested in reviewing some general medical information about meningioma, we direct you to the Mayo Clinic's "Symptoms & causes" and "Diagnosis & treatment" web pages.

We point out that the current drug label information for Depo-Provera Contraceptive Injection (Depo-Provera CI), version "Revised: 7/2024", does not include any warning about an increased risk of intracranial meningioma.

For this reason, i.e., failure to warn, we are investigating cases of the contraceptive injection Depo-Provera being linked to brain tumors in some women as possible drug injury lawsuits against the responsible pharmaceutical companies.

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Plaintiffs Win the Latest Round in Long-Running Fosamax Femur Fracture Litigation

Federal Appeals Court Rejects Merck's Legal Defense of Federal Preemption in September 2024

 

(Posted by Tom Lamb at Drug Injury Watch)

 

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UPDATE: "Merck Asks High Court to Review 3rd Cir.’s Fosamax Preemption Ruling"

The U.S. Supreme Court has been asked to review a ruling that claims accusing Merck of failing to warn that its osteoporosis drug Fosamax can cause atypical femoral fractures are not preempted because the drug maker failed to show that the FDA would have rejected warnings that satisfied state law.

According to its March 10 petition for certiorari, Merck told the FDA that Fosamax may be associated with certain atypical femoral fractures, and proposed a label change to warn about that risk, but the agency formally denied the proposal without suggesting an alternative....

(3/17/25)

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UPDATE: On November 19, 2024, the US Court of Appeals for the Third Circuit denied Merck’s petition for rehearing and remanded to the district court. How Merck responds to this most recent appellate decision, and whether the Supreme Court decides to intervene in this long-running Fosamax femur fracture litigation again, remain to be seen.

(12/18/24)

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A federal appeals court ruled in September 2024 that more than 500 plaintiffs should have their Fosamax femur fracture drug injury lawsuits reinstated and sent back to the current judge presiding over the federal court Fosamax MDL litigation.

Specifically, the United States Court of Appeals for the Third Circuit issued this opinion, In re: Fosamax (alendronate sodium) Products Liability Litigation, No. 22-3412, (3d Cir. Sept. 20, 2024).

As a result of that September 20, 2024 ruling by a unanimous panel of the US Third Circuit appellate court, those femur fracture drug injury lawsuits pending against defendant Merck in the federal court Fosamax MDL litigation are going to U.S. District Judge Karen Williams for potential future trials.

For a summary of this long-running Fosamax femur fracture litigation as regards the legal defense of federal preemption we get the following information from a Reuters news report by Brendan Pierson, "Court revives more than 500 lawsuits over Fosamax femur fracture risk":

The federal litigation stretches back to 2008, and has now been dismissed and revived twice. All of those decisions have hinged on the issue of federal preemption - whether the federal law governing what pharmaceutical companies are required to put on drug labels overrides, or preempts, state law claims that the label fails to warn consumers.

Merck has argued that it does, saying that in 2009 it proposed adding a warning about femur fractures but was initially rejected by the FDA. The warning was eventually added in 2011.

Now-deceased U.S. District Judge Joel Pisano in Trenton, New Jersey, ruled in Merck's favor on the preemption issue in 2013, but the 3rd Circuit overturned that ruling in 2017, concluding that issue should have been decided by a jury.

The U.S. Supreme Court in 2019 ordered the issue reconsidered once again, saying it was a legal issue for a judge, not a jury.

In 2022, U.S. District Judge Freda Wolfson, who had taken over the case [but has since retired], again sided with Merck on preemption.

The 3rd Circuit on [September 20, 2024], however, again reversed. It said that, even though the FDA had not approved the specific warning proposed by Merck in 2009, it would not necessarily have rejected any warning about femur fractures.

While this recent Third Circuit ruling allows the plaintiffs who filed these federal court femur fracture lawsuits to get a jury trial in the future, there are several other possible courses this Fosamax litigation could take from here.

One possibility is that Merck could decide to settle this set of federal court Fosamax lawsuits or, perhaps, all of the remaining Fosamax femur fracture drug injury lawsuits. "About 3,115 lawsuits over Fosamax were pending against Merck in both federal and state courts around the country as of June 30", according to the above Reuters news report.

A second possibility, perhaps more likely given the history of this Fosamax femur fracture litigation, is that Merck will appeal this latest ruling on their legal defense of federal preemption issue to the US Third Circuit sitting en banc or even up to the US Supreme Court.

We will continue to monitor this long-running Fosamax femur fracture litigation and keep you informed of significant developments.

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