In 2014, the U.S. Food and Drug Administration gave AstraZeneca and Bristol-Myers Squibb approval to sell Farxiga in the U.S. The agency previously denied the companies’ request because of cancer concerns.
The FDA required a bladder cancer warning on Farxiga’s label.
Bladder Cancer and Farxiga
People who took Farxiga in clinical studies were five times more likely to develop bladder cancer than people who took another diabetes drug.
Farxiga might also make existing bladder cancer worse or speed up the development of bladder cancer in people who are at risk.
“The fear is that patients take diabetes drugs for years, and the longer someone takes this drug, the greater their risk of cancer”
Bladder cancer occurs when cells in the bladder grow and form a tumor. Bladder cancer can be deadly and is particularly dangerous for diabetics.
The American Cancer Society estimates that doctors will diagnose about 81,190 people with bladder cancer in 2018.
About 12,540 men and 4,720 women will die from the disease.
Farxiga Bladder Cancer Clinical Studies
Researchers investigated a link between Farxiga and bladder cancer in 22 clinical studies. People who took Farxiga had more new cases of bladder cancer than those who did not.
There were four cases of bladder cancer in people who took Farxiga for more than a year and no cases with placebo or other diabetes drugs.
The drug’s label said that there were too few cases to know if Farxiga caused the bladder cancer. Researchers could not determine whether Farxiga had an effect on pre-existing bladder tumors.
The FDA still said that patients with active bladder cancer should not take Farxiga because the drug could make cancer worse. Doctors should use caution when prescribing the drug to people who have had bladder cancer before.
FDA Rejected Farxiga Over Cancer Concerns
The FDA rejected Farxiga in 2012 because of cancer concerns and questions about how well the drug works.
- Liver problems
- Heart disease
The agency later that year looked at additional data on the drug. FDA doctors and scientists expressed concerns about risks and benefits. They also had several unanswered questions.
Nonetheless, in 2014, the FDA said the drugmakers could sell Farxiga if they continued to study the drug’s risks.
The conditions of the approval required the drugmakers to study 17,000 diabetes patients for at least four years. The goal is to determine how the drug affects patients over a longer period.
As of February 2018, the FDA had not released the results of the additional studies.
Other Farxiga Side Effects
Farxiga may cause other serious side effects besides bladder cancer. Other drugs in the same class also have these risks.
These include ketoacidosis, kidney injury and urinary tract infections.
Between March 2013 and May 2015, the FDA found 73 cases of ketoacidosis in patients treated with drugs like Farxiga.
Ketoacidosis is a serious condition in which the body produces high levels of blood acids called ketones. People who develop ketoacidosis often end up in the hospital. Some patients die.
Some people who took Farxiga suffered from acute kidney injury and went to the hospital for dialysis. In 2016, the FDA strengthened its kidney injury warning for Farxiga.
The FDA identified 28 people who developed acute kidney injury after taking Farxiga. These people took the drug between March 2013 and October 2015.
Urinary Tract Infections (UTIs)
Farxiga increases the risk of urinary tract infections (UTIs). Some people ended up in the hospital as a result.
People taking Farxiga have developed two types of serious and potentially fatal urinary tract infections. The infections are called urosepsis and pyelonephritis.
Urosepsis happens when bacteria from a UTI infects the bloodstream. Pyelonephritis occurs when bacteria from a UTI invades essential kidney tissue.
Please seek the advice of a medical professional before making health care decisions.