FDA Issues Warnings on Diabetes Drugs

FDA Issues Warnings on Diabetes Drugs | Pintas & Mullins Law Firm

The FDA recently announced that six diabetes drugs are causing serious blood problems in patients. The drugs, including Farxiga and Invokana, can cause a disorder known as diabetic ketoacidosis. Our team of diabetes drug lawyerswarns the public that medications to treat Type 2 diabetes can cause severe, life-threatening side effects.

Diabetic ketoacidosis occurs when the body produces high levels of ketones, which are types of blood acids. This complication is normally seen in patients with Type 1 diabetes, which makes these recent reports all the more disturbing. All patients suffering this side effect had to be hospitalized or go to the ER, and some continue to experience complications.

Signs and symptoms of diabetic ketoacidosis develop quite quickly, and can include:

• Nausea and vomiting 
• Fruity-scented breath 
• High blood sugar levels 
• Excessive thirst and frequent urination 
• Abdominal pain 
• Confusion 
• Unusual fatigue

Normally, when sugar enters the body it is used as energy for muscles and other tissue with the help of insulin. If there is not enough insulin in the body, cells cannot convert sugar to energy, prompting the release of hormones that break down fat as an alternate energy source. This process then produces toxic acids – ketones – and any excess acids spill over into the urine.

Diabetic ketoacidosis is usually triggered by an infection or illness, such as pneumonia or a UTI. Missed insulin treatments or improper insulin therapy can also trigger the condition, along with alcohol or drug abuse, physical or emotional trauma, or high fever. 
If left untreated, diabetic ketoacidosis can be fatal. Those at highest risk of fatal complications are patients younger than 19 and patients who frequently miss insulin doses.

Six Drugs Named in FDA Reports

The six drugs causing this condition make up the class of Type 2 diabetes drugs called sodium-glucose contransporter-2 inhibitors, or SGLT2 inhibitors. These include Farxiga, Xigduo XR, Invokana, Invokamet, Jardiance, and Glyxambi.

At least one of the manufacturers (Janssen, which makes Invokana and Invokamet) did report that there were cases of diabetic ketoacidosis during clinical trials.

Diabetes Drugs Marketed as Weight-Loss Aids

We recently wrote a post involving three of these drugs (Farxiga, Jardiance, and Invokana) and how they are marketed. The FDA has been asked to penalize makers of these drugs for advertising them as weight-loss products. A public advocacy group stated these direct-to-consumer ads are misleading, overstating the benefits of these drugs while undermining the very real and severe risks. The FDA has never reviewed the validity of weight loss from diabetes drugs, and the recent diabetic ketoacidosis developments are further proof that these drugs are causing much more harm than good.

Farxiga has also been linked to bladder cancer and Invokana has been linked to cardiovascular and bone risks. Despite these known serious risks, millions of prescriptions continue to be written and filled.

Nearly 26 million Americans have diabetes, and the vast majority suffers from Type 2. Unfortunately, drugs have become the first line of treatment to help lower blood sugar levels, even though study after study shows drugs increase the risk of death, heart attack, cancer, and other complications. The problem with these drugs is that they do not treat the underlying cause of diabetes and do not prevent the long-term damage caused by Type 2 diabetes. They merely mask the symptoms short-term, so patients believe they have a handle on a disease that is ravaging their body.

The hard truth: Type 2 diabetes is directly caused by lifestyle, and the only way to successfully treat and eventually reverse it is by implementing lifestyle changes. It is best to speak with your doctor, but some of the lifestyle changes with the most far-reaching and irrefutable effects are also the most obvious: cutting out added sugar and processed foods, exercising, following a nutrition plan, and addressing any underlying emotional issues. 

Physician’s advice on how to treat Type 2 diabetes through lifestyle changes is safe, effective, and cost-effective – unlike relying on drugs. Of course, advice must be combined with social support and skill building, so you can understand how your choices affect your health and take action. The financial, emotional, and physical burden of Type 2 diabetes and the drugs prescribed for it is staggering. It’s time patients take their own health and wellbeing into their own hands.

The dangerous drug lawyers at Pintas & Mullins Law Firm are currently accepting cases of serious injury and death from diabetes drugs. We offer free, confidential legal consultations to concerned patients nationwide.