AstraZeneca’s Farxiga Safety Claims Contradict FDA Findings

News » AstraZeneca’s Farxiga Safety Claims Contradict FDA Findings

Farxiga Safety Claims Contradicted By FDA

Last month at the American Diabetes Association’s (ADA) 77th Scientific Sessions, AstraZeneca Plc. presented new data supporting the safety and effectiveness of their SLGT-2 inhibitor Farxiga.

The data presented about Farxiga safety claims is in direct contention with the FDA’s recent findings that led the agency to mandate SLGT-2 inhibitors to carry black-box labels warning consumers of the increased health risks involved with the drugs.

AstraZeneca’s Farxiga safety claims directly contradicted those FDA findings.

AstraZeneca’s Safety Claims ‘No Safety Signals for Farxiga’

AstraZeneca analyzed data pooled from 30 in-house clinical trials of Farxiga and presented the data to the ADA.

Their safety analysis of these clinical trials found no new safety signals for it.

Adverse health risks for users were generally similar to patients in the control group, with almost identical risks of lower limb amputation for both groups.

CVD-REAL Study of AstraZeneca's Farxiga

AstraZeneca also referred to findings from the CVD-REAL study, a real-world evidence analysis of SGLT-2 inhibitor patients that was published in May 2017.

The multi-country analysis documented the results of more than 30,000 type-2 diabetes patients using Farxiga or similar products.

Patients using SGLT-2 inhibitors showed a rate of reduction in hospitalization for kidney disease and heart failure as compared to patients using DPP-4 inhibitors.

Further analysis from CVD-REAL found decreased risks in cardiovascular deaths and hospitalization for heart failure for type-2 diabetes patients using SGLT-2 inhibitors as compared to patients using other type-2 diabetes treatments.

The range of data from CVD-REAL gives the study’s findings credibility.

But the safety of Farxiga itself should still be brought to question.

AstraZeneca Presents Farxiga Safety Claims to ADA

AstraZeneca’s ADA presentation introduced data that claimed the drug was safe for consumer use.

But these claims are based on a compilation of in-house trials, with no outside supportive data.

AstraZeneca’s safety claims contradict the new FDA-mandated black box label for SLGT-2’s.

The label was authorized after a recent FDA study showed increased risks of amputation for SLGT-2 patients.

While AstraZeneca’s analysis claimed no increased risks for patients, the FDA found increased risks of lower-limb amputation for patients using SLGT-2’s.

These findings lead the FDA to mandate new black-box labels for all SLGT-2 inhibitors including Farxiga.

The manufacturer’s diabetes portfolio saw an increase in stock value in 2016, which is partially a credit to the increase in popularity of the drug.

In the first quarter of 2017 (1Q17), AstraZeneca witnessed a 7% year-over-year drop in U.S. market earnings for their diabetes portfolio.

While Farxiga had a slight increase in earnings in the U.S. market during 1Q17, it was nothing compared to the drug’s 1Q17 market earnings abroad.

This is likely because of the FDA’s new mandates and restrictions, which have made it less desirable to U.S. consumers.

By exposing the risks associated with it, the FDA has damaged the drug’s image for U.S. consumers.

A decline in favorability of the drug in the U.S. could drastically affect AstraZeneca’s U.S. market earnings for their diabetes portfolio, which has already taken a hit in 1Q17.

AstraZeneca’s unsupported claims to the ADA seem to be an effort to change the public perception of Farxiga and save their earnings at the cost of consumer safety.

Inaccurate Farxiga Safety Claims - Patients Legal Options

Patients who took Farxiga and experienced adverse health effects not listed as potential side effects could potentially qualify to participate in a diabetes drug lawsuit.

If you or a loved one has been injured by Farxiga, contact an experienced Invokana lawyer to discuss your legal options today.

TorHoerman Law has a team of experienced bad drug lawyers who are available to discuss your situation, free of charge.

Contact us today to learn how we can help you gain compensation for AstraZeneca’s negligent actions.

“AstraZeneca Presents New Data Underpinning Safety Profile and Real-World CV Outcomes of Farxiga at ADA 2017.” AstraZeneca – Research-Based BioPharmaceutical Company, 12 June 2017,

Patrick  | Jul 7, 2017 7:24 pm EDT, Margaret. “Farxiga Expected to Drive AstraZeneca’s Performance in Diabetes Segment.” The Major Growth Drivers for AstraZeneca in 2017, Market Realist, 7 July 2017,




Tom Lewis

TorHoerman Law was responsible for handling a medical case for our family. I was extremely impressed with their professionalism and ability to react quickly. They also did a nice job keeping us updated with the case throughout the process. This was the first time experiencing a situation like this and Tor Hoerman law did an excellent job from start to finish.

Jordan Terry

TorHoerman Law is an extraordinary law firm – a firm that truly makes the client’s best interests the primary concern. Their team of personal injury lawyers are experienced, personable, and well versed in a range of litigation areas. They are supported by a dedicated team of staff that are as equally friendly and helpful. I would recommend TorHoerman Law for any personal injury litigation needs.

Dave Woodley

All of my questions were answered quickly and in a way I could understand. Steve and the entire staff were friendly and professional.

Jordan Butler

I highly recommend this law firm! The attorneys and staff at THL worked hard, communicated every step of the process, kept me well informed at all times, and exceeded all expectations! The staff is kind, considerate, professional, and very experienced. Look no further, call now!

Maddy Moeller

Top-notch, hardworking attorneys!

Karen Hersman

A wonderful and professional legal team. They helped me when I needed expert legal representation! Thank you TorHoerman Law!

Angel Truesdale

They contacted me the next day. Very nice people!

Paul Graegin

The firm went above and beyond. Thank you for everything.

Carie Terry

The attorneys at THL were extremely helpful with the legal aspects of setting up my small business.

We'll Help You Balance The Scales of Justice

We're ready to fight for you. We're ready to be your ally. And we're ready to start right now.

Dont' waste time, contact our law offices today.

Edwardsville, IL

Chicago, IL

St. Louis, MO

Disclaimer: The contents of this webpage have been prepared by TorHoerman Law, LLC for informational purposes only. None of this information is intended as either legal or medical advice or opinions. No attorney/client relationship is established with use of this website. Sending or receiving information through this site, posting to our blogs/news site does not establish an attorney/client relationship. An attorney/client relationship with TorHoerman Law is established only by an express and written agreement by TorHoerman Law to represent you. Our attorneys make a case-by-case assessment of any claims and results may vary depending on the facts concerning any case. The attorneys at TorHoerman Law are licensed to practice in Illinois, Missouri, and California. In some circumstances, cases may be sent to other qualified lawyers. In those circumstances, TorHoerman Law maintains joint responsibility.