An Exhaustive Review of the Safety Profile, Regulatory Actions, and Litigation History of Farxiga (Dapagliflozin)

Introduction: Deconstructing the “Recall” Inquiry

The question of whether the prescription medication Farxiga (dapagliflozin) has been recalled is a direct reflection of significant public and regulatory concern regarding its safety profile. To be precise, Farxiga has not been subject to a market-wide recall, which is a regulatory action typically reserved for defective products or those posing an imminent and severe health risk that necessitates their complete removal from public access.¹ The drug remains available to patients by prescription in the United States and other countries.

However, the premise of the query points to a more complex and troubling reality. Farxiga’s history since its approval has been punctuated by a series of significant safety warnings and labeling updates mandated by the U.S. Food and Drug Administration (FDA) and other global health authorities. These actions, while falling short of a full recall, represent the regulatory mechanism for addressing serious, and in some cases life-threatening, adverse events discovered after a drug has entered the market. The cumulative weight of these alerts—concerning risks from diabetic ketoacidosis to flesh-eating infections—has understandably created public apprehension and fueled litigation, leading to the perception that the drug’s status might be precarious.

To provide a comprehensive answer, it is essential to understand the distinctions within the FDA’s regulatory toolkit:

• Product Recall: The most severe action, involving the removal of a product from the market, which has not occurred for Farxiga.¹
• Safety Communication: An alert issued by the FDA to inform patients and healthcare providers of an emerging safety concern, often based on post-market surveillance data. Farxiga has been the subject of multiple such communications.⁴
• Label Update/Revision: A formal change to a drug’s prescribing information to add or strengthen warnings, precautions, or information about adverse reactions. This has occurred numerous times for Farxiga and its class.⁴
• Boxed Warning: The FDA’s most stringent warning, designed to highlight risks of serious or life-threatening adverse effects.¹ While Farxiga’s competitor, Invokana, received a boxed warning for amputation risk (which was later removed), Farxiga itself has not been subject to this level of warning.⁹

This report will therefore deconstruct the “recall” question to address the user’s underlying concern: “What are the true, documented dangers associated with Farxiga?” It will provide a definitive, evidence-based analysis of the specific safety issues that have prompted years of regulatory scrutiny and legal challenges. By examining the drug’s mechanism, its contentious path to approval, the chronology of FDA warnings, its risks relative to competitors, and the history of the subsequent litigation, this report will provide a complete picture of Farxiga’s troubled but ongoing presence in the pharmaceutical landscape.

Section 1: Profile of Farxiga (Dapagliflozin) and the SGLT2 Inhibitor Class

A complete understanding of Farxiga’s safety controversies requires a foundational knowledge of its novel mechanism of action, its expanding therapeutic role, and its difficult journey to regulatory approval. The drug’s unique pharmacological properties are inextricably linked to both its benefits and its most significant risks.

1.1 Mechanism of Action: A Novel Approach to Glycemic Control

Farxiga’s active ingredient, dapagliflozin, is a member of a class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.³ The SGLT2 protein, located in the proximal tubules of the kidneys, is responsible for reabsorbing approximately 90% of the glucose that is filtered from the blood back into circulation.¹²

Farxiga works by selectively and reversibly inhibiting this SGLT2 protein.¹⁶ By blocking this transport mechanism, the drug prevents the kidneys from reabsorbing glucose, forcing it to be expelled from the body through the urine—a process known as glycosuria.¹³ This mode of action is independent of pancreatic beta-cell function and insulin sensitivity, which set it apart from many older classes of diabetes medications.¹⁸

This primary mechanism has several secondary physiological effects that are crucial to understanding both its therapeutic benefits and its adverse event profile. The excretion of glucose creates an osmotic diuretic effect, leading to the removal of excess water and sodium (natriuresis) from the body.¹² This reduction in the body’s total fluid volume contributes to several of the drug’s key benefits, including a modest reduction in blood pressure and a decrease in the workload on the heart (cardiac preload and afterload).¹³ These hemodynamic effects are now believed to be central to the drug’s proven ability to protect the heart and kidneys.¹²

1.2 Approved Indications: An Expanding Therapeutic Role

Farxiga was initially developed and approved as a treatment for type 2 diabetes, but its role in medicine has expanded dramatically as large-scale clinical trials revealed profound benefits in other major chronic diseases.

• Initial Approval (January 2014): The FDA first approved Farxiga as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).¹³ From the outset, its labeling has explicitly stated that it is not for the treatment of type 1 diabetes mellitus or for patients with diabetic ketoacidosis.¹³
• Expanded Cardiovascular and Renal Indications: The true transformation in Farxiga’s clinical utility came from landmark cardiovascular outcomes trials (CVOTs). Studies such as DAPA-HF (Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure), DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease), and DELIVER (Dapagliflozin Evaluation to Improve the LIVES of Patients with Preserved Ejection Fraction Heart Failure) demonstrated that the drug’s benefits extended far beyond blood sugar control.¹⁷ These trials showed that Farxiga could significantly reduce the risk of death and hospitalization in patients with heart failure and slow the progression of chronic kidney disease, even in patients who did not have diabetes.¹⁷ This led to a series of supplemental FDA approvals that broadened its indications:

• October 2019: To reduce the risk of hospitalization for heart failure in adults with T2DM who have established cardiovascular disease or multiple risk factors.¹³
• May 2020: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), regardless of their diabetes status.¹³
• April 2021: To reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression.¹³
• May 2023: An expansion of the heart failure indication to cover a broader range of patients, including those with heart failure with preserved ejection fraction (HFpEF).¹⁹
• Pediatric Approval (June 2024): Based on the T2NOW clinical trial, the FDA extended Farxiga’s indication to improve glycemic control in pediatric patients aged 10 years and older with T2DM.¹³

This evolution presents a critical paradox. A drug that entered the market under a cloud of safety concerns has since been proven to be a life-saving, cornerstone therapy for some of the world’s most prevalent and deadly conditions. This dual narrative—of significant risk and profound benefit—is essential for understanding why the drug was never recalled and why its use has grown exponentially despite the well-documented dangers. For many high-risk patients, the proven cardio-renal benefits are considered to outweigh the potential harms.

1.3 A Contentious Path to Market: The 2012 FDA Rejection

Farxiga’s journey to the U.S. market was not smooth. In January 2012, the FDA issued a Complete Response Letter, rejecting the initial New Drug Application (NDA) submitted by its developers, Bristol-Myers Squibb and AstraZeneca.¹⁹ The agency’s rejection was not based on a lack of efficacy; clinical trials had shown that the drug effectively lowered blood glucose.²⁷ Instead, the FDA requested more clinical data to better characterize the drug’s benefit-risk profile, citing specific safety concerns that had emerged from the trial data.³

The most prominent concern was a numerical imbalance in bladder cancer cases. An FDA medical review from the time noted that there were 10 cases of bladder cancer among 6,045 dapagliflozin-treated patients, compared to just one case among 3,512 patients in the control group.²⁹ Although the number of cases was small, the imbalance was statistically concerning and raised a red flag for the regulators.²⁷ The FDA also noted concerns regarding potential cardiovascular risks and liver safety that required further investigation.³

The manufacturers conducted additional analyses and resubmitted the NDA in July 2013.¹⁹ In December 2013, an FDA Advisory Committee, a panel of external experts, reviewed the new data package. Despite the lingering questions, the committee voted 13-to-1 to recommend approval, concluding that the benefits of the new therapeutic option for diabetes outweighed the potential risks, provided that those risks were studied further post-approval.¹⁹ Following this recommendation, the FDA officially approved Farxiga on January 8, 2014, but mandated a series of post-marketing studies to monitor these safety signals long-term.¹³ This contentious approval process set the stage for the intense regulatory scrutiny that would follow.

Section 2: A Chronology of Regulatory Scrutiny: Key FDA Safety Warnings

Following its 2014 approval, Farxiga and the broader SGLT2 inhibitor class became the subject of a series of FDA safety communications as post-marketing surveillance and ongoing research uncovered serious adverse events not fully apparent in the initial clinical trials. The following timeline and detailed analysis chronicle the accumulation of these safety concerns.

Table 1: Timeline of Key FDA Actions and Safety Warnings for Farxiga and SGLT2 Inhibitors

Date	Event/Action	Affected Drugs	Key References
Jan 2012	FDA Rejects Farxiga New Drug Application	Dapagliflozin	19
Jan 2014	FDA Approves Farxiga	Dapagliflozin	19
May 2015	FDA Warns of Ketoacidosis Risk	All SGLT2 Inhibitors	31
Dec 2015	FDA Adds Warnings for Ketoacidosis & Serious UTIs	All SGLT2 Inhibitors	5
Jun 2016	FDA Strengthens Warnings for Acute Kidney Injury	Dapagliflozin, Canagliflozin	4
May 2017	FDA Adds Boxed Warning for Amputation Risk	Canagliflozin (Invokana) only	9
Aug 2018	FDA Warns of Fournier’s Gangrene Risk	All SGLT2 Inhibitors	10
Aug 2020	FDA Removes Boxed Warning for Amputation Risk	Canagliflozin (Invokana) only	11

2.1 Diabetic Ketoacidosis (DKA): The First Major Post-Market Alarm (2015)

In May 2015, just over a year after Farxiga’s approval, the FDA issued its first major safety communication concerning the entire SGLT2 inhibitor class.³¹ The agency warned that these drugs could lead to diabetic ketoacidosis (DKA), a life-threatening condition in which high levels of blood acids called ketones accumulate, potentially requiring hospitalization.³ The warning was based on a review of the FDA Adverse Event Reporting System (FAERS), which identified 20 cases of acidosis linked to SGLT2 inhibitors between March 2013 and June 2014.³¹

A critical and dangerous feature highlighted in the warning was the atypical presentation of these cases. DKA is typically associated with very high blood sugar levels (hyperglycemia). However, many of the patients taking SGLT2 inhibitors developed severe ketoacidosis with only moderately elevated or even near-normal blood glucose levels, a condition termed “euglycemic DKA”.⁵ This unusual presentation posed a significant diagnostic challenge, as clinicians might not suspect DKA in a patient without severe hyperglycemia, leading to potentially fatal delays in treatment.⁵

By December 2015, the FDA had identified 73 cases of ketoacidosis in patients treated with SGLT2 inhibitors, all of whom required emergency room visits or hospitalization.⁵ This prompted the agency to mandate that the manufacturers of all SGLT2 inhibitors, including Farxiga, add new warnings and precautions about the risk of DKA to their drug labels.⁵ The labels were updated to identify risk factors that could predispose patients to DKA, such as acute febrile illness, reduced caloric intake, surgery, and alcohol abuse.³⁹ Patients were instructed to stop taking the medication and seek immediate medical attention if they experienced symptoms of DKA, including nausea, vomiting, abdominal pain, unusual fatigue, or difficulty breathing.⁵

2.2 Acute Kidney Injury (AKI): A Direct Consequence of the Drug’s Mechanism (2016)

The next major regulatory action came in June 2016, when the FDA strengthened its warnings regarding the risk of acute kidney injury (AKI) for Farxiga (dapagliflozin) and its competitor Invokana (canagliflozin).⁴ This safety concern is directly tied to the drug’s primary mechanism of action. The osmotic diuresis caused by SGLT2 inhibition can lead to intravascular volume depletion (dehydration), which in turn can impair kidney function and, in susceptible individuals, precipitate acute kidney injury.⁷

The FDA’s decision was based on an analysis of 101 confirmable cases of AKI reported to FAERS between March 2013 and October 2015. Of these, 28 cases were specifically associated with dapagliflozin.⁴ The events were serious: 96 of the 101 cases required hospitalization, and four patients died during their hospital stay.⁴ The FDA noted that in about half of the cases, the kidney injury occurred within one month of starting the drug, and most patients’ kidney function improved after the medication was discontinued, indicating a causal link.⁴

The revised labels included new recommendations to minimize this risk. The FDA advised healthcare professionals to assess a patient’s volume status and kidney function before initiating Farxiga and to consider factors that increase the risk of AKI. These risk factors include pre-existing kidney impairment, advanced age, and the concurrent use of other medications that can affect the kidneys or blood pressure, such as diuretics, ACE inhibitors, ARBs, and nonsteroidal anti-inflammatory drugs (NSAIDs).⁴ Patients were advised to seek immediate medical help for symptoms of AKI, such as decreased urine output or swelling in the legs and feet, and to promptly inform their doctor if they were experiencing significant fluid loss due to illness, vomiting, or diarrhea.⁴

2.3 Severe Infections: An Inevitable Risk of Glycosuria

The mechanism of forcing glucose into the urine (glycosuria) creates a predictable downstream risk: the sugar-rich urinary and genital environment becomes a fertile breeding ground for microorganisms. This has led to two distinct categories of infection-related warnings for the SGLT2 inhibitor class.

2.3.1 Serious Urinary Tract Infections (UTIs)

In December 2015, alongside the strengthened DKA warning, the FDA mandated label updates for all SGLT2 inhibitors to warn about the risk of serious urinary tract infections.⁵ While common UTIs were a known side effect from clinical trials, post-marketing reports revealed that some of these infections could become life-threatening. The FDA’s review of the FAERS database from March 2013 through October 2014 identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that began as UTIs in patients taking these drugs.⁵ All 19 patients required hospitalization, and several needed intensive care or dialysis due to kidney failure.⁵ The new warnings advised physicians to monitor patients for signs of UTIs and treat them promptly.⁵

2.3.2 Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)

A far rarer but more gruesome infection risk emerged in August 2018, when the FDA issued a safety communication about necrotizing fasciitis of the perineum, a rapidly progressing, flesh-eating bacterial infection commonly known as Fournier’s Gangrene.¹⁰ This condition requires urgent surgical debridement and has a high mortality rate.³⁸

The FDA’s warning was prompted by the identification of 12 cases of Fournier’s gangrene in patients taking SGLT2 inhibitors between March 2013 and May 2018.³⁵ All 12 patients were hospitalized and required surgery, with some undergoing multiple disfiguring procedures; one patient died.³⁵ This was a powerful safety signal because the condition is extremely rare. For comparison, a review of all other classes of diabetes drugs over a 30-year period found only six cases.³⁵ The proposed mechanism is that the glucose-rich environment fostered by SGLT2 inhibitors can allow a minor skin break or a common genital infection to escalate into this devastating necrotizing infection.⁴⁸ The FDA required a new warning about this risk to be added to the prescribing information for all SGLT2 inhibitors.³⁵

2.4 The Bladder Cancer Question: The Lingering Shadow from Approval

The concern over a potential link between Farxiga and bladder cancer predates the drug’s approval and has remained a subject of ongoing investigation. This issue was a primary factor in the FDA’s initial rejection of the drug in 2012.²⁷

The initial clinical trial data submitted to the FDA showed a numerical imbalance in bladder cancer cases. An FDA medical review documented 10 cases in 6,045 patients treated with dapagliflozin versus only 1 case in 3,512 patients in the control arm.²⁹ Although the absolute number of cases was small, the disparity was concerning enough for the FDA to demand further study.²⁹

Upon finally approving Farxiga in 2014, the FDA mandated several post-marketing studies to continue monitoring this risk. These requirements included a long-term cardiovascular outcomes trial (the DECLARE trial) that would also assess bladder cancer incidence, two additional bladder cancer risk studies, and an animal study to evaluate potential mechanisms of tumor promotion.²⁷ The drug’s label explicitly states that Farxiga is not recommended for patients with active bladder cancer and that patients with a history of bladder cancer should use it with caution.³

Subsequent research has yielded mixed results. Pre-clinical animal studies in rats and mice did not find dapagliflozin to be carcinogenic.⁵¹ A large meta-analysis of 46 clinical trials published in 2017 found no overall increased risk of cancer with SGLT2 inhibitors and suggested the initial imbalance might have been due to “detection bias”—meaning that the higher rate of urinary side effects in the dapagliflozin group led to more urological investigations, thus uncovering pre-existing cancers that went undiagnosed in the control group.⁵³ However, the authors of that analysis cautioned that the evidence was not conclusive and that long-term monitoring was still necessary.⁵³ To this day, the bladder cancer question remains a part of Farxiga’s complex safety narrative, illustrating the long shadow that early safety signals can cast over a drug’s lifecycle.

Section 3: Comparative Risk Analysis: Farxiga in the Context of its Class

Evaluating the safety of Farxiga requires placing it in the context of its therapeutic class. The SGLT2 inhibitor market is dominated by three main products: Farxiga (dapagliflozin), Invokana (canagliflozin), and Jardiance (empagliflozin). While they share a common mechanism of action and many of the same risks, there are critical differences in their documented safety profiles that have influenced regulatory actions and clinical practice.

Table 2: Comparative Safety Profile of Major SGLT2 Inhibitors (Farxiga vs. Invokana vs. Jardiance)

Adverse Event	Farxiga (dapagliflozin)	Invokana (canagliflozin)	Jardiance (empagliflozin)
Diabetic Ketoacidosis (DKA)	Yes. Class-wide FDA warning (Dec 2015) applies. Considered a known risk. 5	Yes. Class-wide FDA warning (Dec 2015) applies. Considered a known risk. 5	Yes. Class-wide FDA warning (Dec 2015) applies. Considered a known risk. 5
Acute Kidney Injury (AKI)	Yes. Strengthened FDA warning (Jun 2016) specifically named dapagliflozin. 4	Yes. Strengthened FDA warning (Jun 2016) specifically named canagliflozin. 4	Yes. Considered a class-wide risk; post-marketing reports of AKI noted. 40
Fournier’s Gangrene	Yes. Class-wide FDA warning (Aug 2018) applies. 35	Yes. Class-wide FDA warning (Aug 2018) applies. 35	Yes. Class-wide FDA warning (Aug 2018) applies. 35
Lower-Limb Amputation	No FDA boxed warning. Some observational studies suggest a possible class effect, but evidence is not as strong as for Invokana. 45	Yes. FDA issued a Boxed Warning in May 2017 based on CANVAS trial data. The warning was removed in Aug 2020, but the risk remains in the precautions section. 9	No FDA boxed warning. Not identified as a significant signal in major clinical trials. 45
Bone Fractures	Not a prominent safety signal in major clinical trials.	Yes. An increased risk of bone fractures was observed in clinical trials and is listed as a warning. 6	Not a prominent safety signal in major clinical trials. 57

3.1 Class-Wide Risks

As detailed in the previous section, several of the most severe risks are considered class-wide effects of SGLT2 inhibition, stemming directly from the shared mechanism of action. These include:

• Diabetic Ketoacidosis (DKA): The FDA’s warnings apply to all drugs in the class.⁵
• Acute Kidney Injury (AKI): While the 2016 strengthened warning specifically named Farxiga and Invokana, AKI is recognized as a potential risk for all SGLT2 inhibitors due to their diuretic effect and potential for volume depletion.⁵⁴
• Fournier’s Gangrene: The 2018 FDA warning about this rare necrotizing infection was a class-wide action.¹⁰
• Genital Mycotic and Urinary Tract Infections: These are the most common side effects and are an established risk across the entire class due to glycosuria.¹³

3.2 Drug-Specific Risks: The Invokana Amputation Signal

The most significant divergence in the safety profiles of these drugs emerged from the risk of lower-limb amputation. Based on the final results of two large clinical trials, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R trials, the FDA concluded that treatment with Invokana (canagliflozin) was associated with an approximately two-fold increased risk of leg and foot amputations compared to placebo.⁹ The amputations most commonly involved the toe and middle of the foot.⁹

This finding was so serious that in May 2017, the FDA took the significant step of requiring a boxed warning—its most stringent safety alert—to be added to the labels of Invokana and its combination products.⁶ This action created a clear point of regulatory differentiation within the class.

Crucially, this boxed warning was never applied to Farxiga or Jardiance. While some later observational studies raised questions about a potential class-wide effect on amputation risk ⁴⁵, the robust clinical trial evidence that prompted the FDA’s strongest warning was specific to Invokana.

This regulatory distinction had significant implications for the market. It created a perception that Invokana carried a unique and severe risk that its main competitors did not, likely influencing prescribing decisions by physicians and choices made by patients.

In August 2020, the FDA removed the boxed warning from Invokana’s label.¹¹ The agency’s decision was based on a re-evaluation of the drug’s overall risk-benefit profile, taking into account new data that had established Invokana’s significant benefits in reducing cardiovascular and renal events. The FDA concluded that while the amputation risk remains and is still described in the “Warnings and Precautions” section of the label, it no longer warranted the severity of a boxed warning when weighed against the drug’s proven life-saving benefits.¹¹

3.3 Other Differentiating Factors

Beyond the amputation signal, other less prominent differences in safety profiles have been noted:

• Bone Fractures: An increased risk of bone fractures, occurring as early as 12 weeks after starting treatment, was observed in clinical trials for Invokana and is included in its warnings.⁶ This signal has not been a prominent concern for Farxiga or Jardiance.⁵⁷
• Adverse Event Frequency: Some comparative data suggests that the rates of certain common side effects may differ between the drugs. For instance, one analysis noted that the reported incidence of vaginal yeast infections was higher with Invokana (11-12%) than with Jardiance (5-6%).⁵⁷

In summary, while Farxiga carries the significant risks common to its class, it has avoided the most severe regulatory action—a boxed warning—that was applied to its key competitor, Invokana. This distinction is a critical piece of context in any assessment of Farxiga’s safety history.

Section 4: The Legal Fallout: The Farxiga Multidistrict Litigation (MDL 2776)

The series of FDA safety warnings, particularly those concerning DKA and kidney injury, triggered a wave of product liability lawsuits against Farxiga’s manufacturers, AstraZeneca and Bristol-Myers Squibb. These legal challenges alleged that the companies failed to adequately inform patients and the medical community about the drug’s serious risks.

4.1 Allegations and Causes of Action: The “Failure to Warn” Lawsuits

Hundreds of individuals who claimed to have been injured after taking Farxiga filed lawsuits across the country.³ The legal arguments presented in these cases were largely consistent and centered on the doctrine of “failure to warn.”

The core allegation was that the manufacturers “negligently, recklessly and carelessly marketed, distributed and sold” Farxiga without providing adequate instructions or warnings about its dangerous side effects.⁶² Plaintiffs contended that the companies knew, or should have known, about the risks of conditions like DKA, kidney failure, and heart attacks long before the FDA mandated warnings be added to the label.³ The lawsuits argued that by the time the FDA acted, it was too late for those who had already suffered harm.⁶² Plaintiffs asserted that if they or their prescribing physicians had been properly informed of the risks, they would have chosen an alternative medication or would have been monitored more closely to allow for early detection of complications.³

The specific legal claims, or causes of action, included:

• Failure to warn about the risks of DKA, kidney failure, heart attack, and stroke.⁶³
• Failure to conduct adequate pre- and post-market testing to identify these risks.⁶³
• Misrepresenting the safety and efficacy of the drug.⁶³
• Negligence in the design, marketing, and sale of the drug.⁶²
• Failure to issue a recall once the dangers became known.⁶³

The injuries cited in the lawsuits mirrored the FDA warnings, including DKA, acute kidney injury, cardiovascular events, and the rare but deadly Fournier’s Gangrene.⁶²

4.2 The MDL Proceedings and Resolution

Given the large number of lawsuits involving similar factual questions, the U.S. Judicial Panel on Multidistrict Litigation (JPML) took action. In April 2017, the panel consolidated the federal Farxiga lawsuits into a multidistrict litigation (MDL), designated as In re: Farxiga (Dapagliflozin) Products Liability Litigation, MDL No. 2776. The MDL was assigned to the Honorable Lorna G. Schofield in the U.S. District Court for the Southern District of New York.¹⁰

The purpose of an MDL is to centralize and streamline complex pretrial proceedings, such as the discovery process (gathering evidence) and rulings on the admissibility of expert witness testimony (known as Daubert hearings). This process is intended to conserve the resources of the courts and the parties involved and prevent inconsistent rulings across different jurisdictions.⁶⁶ Court records from the MDL show that key plaintiff allegations, including claims that the manufacturers failed to warn about DKA and engaged in off-label promotion, survived early motions by the defendants to dismiss the cases.⁶⁷

The outcome of the Farxiga MDL, however, stands in stark contrast to that of its competitor, Invokana. The Invokana MDL, which involved over 1,000 lawsuits and more severe allegations related to amputations, was largely resolved through a confidential settlement fund established by its manufacturer in 2018.⁶¹

The Farxiga MDL followed a different path. In 2020, the MDL was officially terminated by the JPML with no global settlement or major trial verdicts having been reported.¹⁰ A total of 67 cases that had been consolidated in the MDL were closed, and one remaining case was sent back (remanded) to the court where it was originally filed for further proceedings.⁶² Since the termination of the MDL, major law firms that were once soliciting Farxiga cases have largely ceased doing so.²

The lack of a large-scale settlement in the Farxiga litigation is significant. It may reflect several factors. First, the plaintiffs’ case may have been viewed as weaker without a unique, high-impact injury like the amputations that were central to the Invokana lawsuits. The primary injuries alleged in the Farxiga cases (DKA, AKI) were class-wide risks, making it more difficult to argue that AstraZeneca bore a unique liability. Second, the legal strategy of the manufacturer may have been to contest the cases more aggressively rather than create a large settlement fund. Finally, the timing may have been critical. By 2020, when the MDL was terminated, the overwhelmingly positive data from Farxiga’s cardio-renal outcomes trials was public knowledge, dramatically strengthening the “benefit” side of the drug’s risk-benefit equation and potentially making it more challenging for plaintiffs to argue in court that the drug was unreasonably dangerous.

Section 5: Synthesis and Conclusive Analysis

The history of Farxiga (dapagliflozin) is a compelling case study in modern pharmaceutical development, regulation, and litigation. While the drug was never “recalled” in the formal sense of a market withdrawal, the user’s query correctly identifies a product with a deeply troubled safety record that has warranted repeated and serious interventions from the FDA.

The analysis reveals a clear and consistent theme: the very mechanism that makes Farxiga an effective therapeutic is also the source of its most significant harms. The pharmacologically-induced excretion of glucose and water from the body—glycosuria and osmotic diuresis—is the direct or indirect cause of the drug’s primary adverse events. This process lowers blood sugar and confers profound protection on the heart and kidneys, yet it simultaneously creates the conditions for dehydration, acute kidney injury, urinary tract infections, and rare but devastating complications like diabetic ketoacidosis and Fournier’s Gangrene. The risks are not idiosyncratic; they are intrinsically woven into the drug’s mode of action.

This history underscores the critical importance of post-market surveillance. The most severe safety signals for Farxiga and the SGLT2 inhibitor class were not fully appreciated in the pre-approval clinical trials but emerged only after the drug was in widespread use among a broader and more complex patient population. The FDA’s Adverse Event Reporting System (FAERS) was instrumental in identifying the patterns of DKA, AKI, and severe infections that led to a cascade of safety communications and label revisions.

This evolving understanding of the drug’s safety profile has created a central paradox. A medication initially scrutinized by the FDA for a potential cancer risk and later warned about for a litany of serious side effects has simultaneously been proven in landmark clinical trials to be a life-saving therapy for millions of people with heart failure and chronic kidney disease. This dual narrative—of accumulating risk and accumulating benefit—is the key to understanding why Farxiga was never recalled and why its use has expanded dramatically. For appropriately selected patients, particularly those with high cardiovascular or renal risk, the proven benefits are now widely considered by the medical community to outweigh the known potential harms.

The legal fallout from these safety issues culminated in the In re: Farxiga (Dapagliflozin) Products Liability Litigation (MDL 2776). However, the resolution of this litigation further highlights Farxiga’s unique position. Unlike its competitor Invokana, whose manufacturer established a large settlement fund to resolve claims related to a drug-specific amputation risk, the Farxiga MDL was terminated without a similar global resolution. This outcome likely reflects the absence of a comparable, high-profile injury unique to Farxiga, as well as the powerful, emerging evidence of the drug’s life-saving benefits, which complicated the legal argument that it was an unreasonably dangerous product.

In conclusion, the answer to the question “Why was Farxiga recalled?” is that it was not. However, the reasons behind the question are valid and significant. Farxiga’s journey has been defined by a continuous re-evaluation of its complex risk-benefit profile. The decision to prescribe or take Farxiga is a significant one that demands a comprehensive and individualized discussion between a patient and their healthcare provider. This discussion must carefully weigh the drug’s documented, substantial benefits against its documented, serious risks in the context of a patient’s specific health conditions and risk factors. This report provides the exhaustive, evidence-based foundation necessary to facilitate that critical conversation.

Works cited

1. Box Warning – StatPearls – NCBI Bookshelf, accessed July 31, 2025, https://www.ncbi.nlm.nih.gov/books/NBK538521/
2. Jardiance and Farxiga Gangrene Lawsuit – Kishish Law Group, accessed July 31, 2025, https://www.kishishlaw.com/jardiance-and-farxiga-gangrene-lawsuit
3. Farxiga Lawsuits – Recall Report, accessed July 31, 2025, https://www.recallreport.org/financial-compensation/farxiga-lawsuits/
4. FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR), accessed July 31, 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-kidney-warnings-diabetes-medicines-canagliflozin
5. FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections, accessed July 31, 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-labels-sglt2-inhibitors-diabetes-include-warnings-about-too-much-acid-blood-and-serious
6. Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors – FDA, accessed July 31, 2025, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sodium-glucose-cotransporter-2-sglt2-inhibitors
7. Label: DAPAGLIFLOZIN tablet, film coated – DailyMed, accessed July 31, 2025, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=82cdd5ad-df2b-4bdd-a3a6-a059040100b4
8. www.ncbi.nlm.nih.gov, accessed July 31, 2025, https://www.ncbi.nlm.nih.gov/books/NBK538521/#:~:text=Boxed%20warnings%20(formerly%20known%20as,major%20risks%20of%20the%20drug.
9. FDA Adds Boxed Warning to Type 2 Diabetes Medication Canagliflozin | Duke Health, accessed July 31, 2025, https://phmo.dukehealth.org/news/fda-adds-boxed-warning-type-2-diabetes-medication-canagliflozin
10. SGLT2 Inhibitors: Benefits, Side Effects, FDA Warnings & Lawsuits – Drugwatch.com, accessed July 31, 2025, https://www.drugwatch.com/sglt2-inhibitors/
11. FDA removes Boxed Warning about risk of leg and foot amputations …, accessed July 31, 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin
12. Dapagliflozin – Wikipedia, accessed July 31, 2025, https://en.wikipedia.org/wiki/Dapagliflozin
13. Farxiga: Uses, Dosage, Side Effects & Warnings – Drugs.com, accessed July 31, 2025, https://www.drugs.com/farxiga.html
14. Forxiga | European Medicines Agency (EMA), accessed July 31, 2025, https://www.ema.europa.eu/en/medicines/human/EPAR/forxiga
15. Mechanism of Action (MOA) | FARXIGA® (dapagliflozin) | For HCPs, accessed July 31, 2025, https://www.farxiga-hcp.com/mechanism-of-action
16. pubmed.ncbi.nlm.nih.gov, accessed July 31, 2025, https://pubmed.ncbi.nlm.nih.gov/25389049/#:~:text=Dapagliflozin%20reduces%20renal%20glucose%20reabsorption,and%20reducing%20blood%20glucose%20levels.
17. FORXIGA (dapagliflozin) Mechanism of Action | AZ UK – AstraZeneca UK, accessed July 31, 2025, https://www.myastrazeneca.co.uk/forxiga/mode-of-action.html
18. [Dapagliflozin, the first SGLT-2 inhibitor in the treatment of type 2 diabetes] – PubMed, accessed July 31, 2025, https://pubmed.ncbi.nlm.nih.gov/24444523/
19. Farxiga (dapagliflozin) FDA Approval History – Drugs.com, accessed July 31, 2025, https://www.drugs.com/history/farxiga.html
20. US FDA approves FARXIGA™ (dapagliflozin) tablets for the treatment of adult patients with type 2 diabetes – AstraZeneca, accessed July 31, 2025, https://www.astrazeneca.com/media-centre/press-releases/2014/us-fda-approved-farxiga-treatment-type-2-diabetes-patients-13012014.html
21. FARXIGA® (dapagliflozin) tablets, for oral use – This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda, accessed July 31, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf
22. FARXIGA for CKD | Heart Failure | Type 2 Diabetes, accessed July 31, 2025, https://www.farxiga.com/
23. www.farxiga.com, accessed July 31, 2025, https://www.farxiga.com/#:~:text=FARXIGA%20is%20a%20prescription%20medicine,adults%20with%20chronic%20kidney%20disease
24. CENTER FOR DRUG EVALUATION AND RESEARCH – accessdata.fda.gov, accessed July 31, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/202293Orig1s026.pdf
25. FDA Approves Dapagliflozin For Pediatric Patients With Type 2 Diabetes – Pharmacy Times, accessed July 31, 2025, https://www.pharmacytimes.com/view/fda-approves-dapagliflozin-for-pediatric-patients-with-type-2-diabetes
26. Diabetes drug dapagliflozin fails to get approval from FDA – Managed Healthcare Executive, accessed July 31, 2025, https://www.managedhealthcareexecutive.com/view/diabetes-drug-dapagliflozin-fails-get-approval-fda
27. FDA approves Farxiga to treat type 2 diabetes; bladder cancer concerns remain, accessed July 31, 2025, https://www.drugtopics.com/view/fda-approves-farxiga-treat-type-2-diabetes-bladder-cancer-concerns-remain
28. Farxiga Overview | Recall Report, accessed July 31, 2025, https://www.recallreport.org/dangerous-drugs-products/farxiga/
29. 202293Orig1s000 – accessdata.fda.gov, accessed July 31, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000MedR.pdf
30. FDA Approves the SGLT-2 inhibitor Farxiga (dapagliflozin) for Type 2 Diabetes | DiaTribe, accessed July 31, 2025, https://diatribe.org/diabetes-medications/fda-approves-sglt-2-inhibitor-farxiga-dapagliflozin-type-2-diabetes
31. M1_DSC SGLT2 inhibitors_8 – Reginfo.gov, accessed July 31, 2025, https://www.reginfo.gov/public/do/DownloadDocument?objectID=61275801
32. Invokana Ketoacidosis Lawsuit | 3/16/2025, accessed July 31, 2025, https://www.forthepeople.com/blog/invokana-ketoacidosis-lawsuit/
33. FDA Updates SGLT2 Warnings for Invokana and Farxiga, accessed July 31, 2025, https://www.rheingoldlaw.com/dangerous-drugs-lawsuit/fda-updates-sglt2-warnings-for-invokana-and-farxiga/
34. FDA Drug Safety Communication: Interim clinical trial results find …, accessed July 31, 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-interim-clinical-trial-results-find-increased-risk-leg-and-foot
35. FDA warns about rare occurrences of a serious infection of the …, accessed July 31, 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2-inhibitors-diabetes
36. 2020 Standards of Care for Diabetes, accessed July 31, 2025, https://www.sfhp.org/wp-content/files/providers/DUR/Diabetes_Education.pdf
37. INVOKANA® (canagliflozin) Official Website HCP, accessed July 31, 2025, https://www.invokanahcp.com/
38. Forxiga, INN-dapagliflozin – European Medicines Agency, accessed July 31, 2025, https://www.ema.europa.eu/en/documents/product-information/forxiga-epar-product-information_en.pdf
39. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FARXIGA safely and effec – accessdata.fda.gov, accessed July 31, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf
40. Safety Profile for T2D | Jardiance® (empagliflozin) tablets – Boehringer Ingelheim, accessed July 31, 2025, https://pro.boehringer-ingelheim.com/us/products/jardiance/t2d/safety
41. Possible Side Effects of FARXIGA® (dapagliflozin), accessed July 31, 2025, https://www.farxiga.com/side-effects
42. Physicians’ Considerations and Practice Recommendations Regarding the Use of Sodium-Glucose Cotransporter-2 Inhibitors – MDPI, accessed July 31, 2025, https://www.mdpi.com/2077-0383/11/20/6051
43. Side Effects of SGLT2 Inhibitors – Renal Fellow Network, accessed July 31, 2025, https://www.renalfellow.org/2022/11/10/side-effects-of-sglt2-inhibitors/
44. Is it safe to take Invokana? – Drugs.com, accessed July 31, 2025, https://www.drugs.com/medical-answers/safe-invokana-3552697/
45. Jardiance and Farxiga: Lower Limb Amputations and Flesh-Eating, accessed July 31, 2025, https://www.njadvocates.com/2018/12/11/jardiance-and-farxiga-lower-limb-amputations-and-flesh-eating-genital-infections/
46. SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) – GOV.UK, accessed July 31, 2025, https://www.gov.uk/drug-safety-update/sglt2-inhibitors-reports-of-fournier-s-gangrene-necrotising-fasciitis-of-the-genitalia-or-perineum
47. Fournier’s Gangrene and Sodium-Glucose Co-Transporter-2 Inhibitors, accessed July 31, 2025, https://jcritintensivecare.org/storage/upload/pdfs/1726733181-en.pdf
48. How do SGLT2 (sodium-glucose linked transporter 2) inhibitors increase the risk of Fournier’s gangrene in patients with type 2 diabetes?, accessed July 31, 2025, https://www.droracle.ai/articles/220158/how-can-sglt2-inhibitors-cause-fourniers-gangrene
49. Fournier’s Gangrene: A Coexistence or Consanguinity of SGLT-2 Inhibitor Therapy – PMC, accessed July 31, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC9450557/
50. POST MARKETING STUDY COMMITMENTS – AstraZeneca US, accessed July 31, 2025, https://www.astrazeneca-us.com/content/dam/az-us/Documents/US-postmarketing-study-commitments%20June%202016.pdf
51. 202293Orig1s000 – accessdata.fda.gov, accessed July 31, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000PharmR.pdf
52. Assessing Bladder Cancer Risk in Type 2 Diabetes Clinical Trials: the Dapagliflozin Drug Development Program as a ‘Case Study’, accessed July 31, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC4575305/
53. Overall cancer risk not increased with use of popular diabetes medication, IU study finds – Indiana University School of Medicine, accessed July 31, 2025, https://medicine.iu.edu/news/2017/09/diabetes-cancer-risk
54. Empagliflozin – StatPearls – NCBI Bookshelf, accessed July 31, 2025, https://www.ncbi.nlm.nih.gov/books/NBK532925/
55. JARDIANCE (empagliflozin) tablets, for oral use – accessdata.fda.gov, accessed July 31, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf
56. The Invokana® Lawsuit for Diabetes Patients – Olsen Law Offices, accessed July 31, 2025, https://www.olsenlawapc.com/personal-injury/product-liability/invokana/
57. Jardiance vs. Invokana for Diabetes Type 2: Important Differences and Potential Risks., accessed July 31, 2025, https://www.goodrx.com/compare/jardiance-vs-invokana
58. pmc.ncbi.nlm.nih.gov, accessed July 31, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC6368009/
59. Safety profile of sodium glucose co-transporter 2 (SGLT2) inhibitors: A brief summary – PMC, accessed July 31, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC9532622/
60. SGLT2 inhibitors – National Kidney Foundation, accessed July 31, 2025, https://www.kidney.org/kidney-topics/sglt2-inhibitors
61. Invokana (Canagliflozin) Products Liability Litigation – Seeger Weiss LLP, accessed July 31, 2025, https://www.seegerweiss.com/product-liability/invokana-litigation/
62. SGLT2 Inhibitor Lawsuits —Amputation, Kidney Failure & Ketoacidosis – Drugwatch.com, accessed July 31, 2025, https://www.drugwatch.com/sglt2-inhibitors/lawsuits/
63. Farxiga Lawsuit – Saiontz & Kirk, P.A. – YouHaveALawyer.com, accessed July 31, 2025, https://www.youhavealawyer.com/farxiga/
64. Jardiance & Farxiga Lawsuits – Fournier’s Gangrene – Levin Papantonio, accessed July 31, 2025, https://levinlaw.com/jardiance-farxiga-lawsuit-fournier-gangrene/
65. Farxiga Lawsuit – Diabetic Ketoacidosis Litigation – Olsen Law Offices, accessed July 31, 2025, https://www.olsenlawapc.com/personal-injury/product-liability/sglt2-inhibitors/farxiga/
66. FARXIGA (DAPAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION MDL No. 27, accessed July 31, 2025, https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2776-Initial_Transfer-03-17.pdf
67. In re: Farxiga (Dapagliflozin) Products Liability Litigation, No. 1:2017mc02776 – Document 96 (S.D.N.Y. 2018) – Justia Law, accessed July 31, 2025, https://law.justia.com/cases/federal/district-courts/new-york/nysdce/1:2017mc02776/473714/96/
68. Guest Post – The Wild West of MDL: Off-Label Promotion, Negligent Testing, & Gross Negligence Claims Survive in Farxiga | Drug & Device Law, accessed July 31, 2025, https://www.druganddevicelawblog.com/2018/05/guest-post-the-wild-west-of-mdl-off-label-promotion-negligent-testing-gross-negligence-claims-survive-in-farxiga.html
69. Invokana Settlement – Compensation for Ketoacidosis Cases – Class Action Lawsuits, accessed July 31, 2025, https://www.classaction.com/invokana/settlement/