Invokana Lawsuit Attorney: FDA warns of foot, leg amputations
Invokana Lawsuit Update:
The Food and Drug Administration announced that Johnson & Johnson is required to add new warnings to its diabetes drug, Invokana, highlighting the risk of foot and leg amputations.
The announcement came after final results from two separate clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, than those who were given a placebo.
People with diabetes are already at risk of having lower limbs amputated because of circulatory and nerve damage that the disease does over time. However, the FDA noted that results of one clinical trial showed that over the course of a year the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, compared with 2.8 out of 1,000 for patients given a placebo.
A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.
Invokana is a medication designed to treat patients who have Type 2 diabetes by helping to remove excess blood sugar through urine.
The drug has also been linked to Acute Kidney Failure and other complications such as Ketoacidosis, which wasn’t always listed as a possible side effect.
Ketoacidosis develops when the pH balance of a patient’s blood drops significantly due to the body’s inability to regulate the natural production of ketones. When the condition develops in type 1 diabetics, a spike in blood sugar levels typically occurs. Blood sugar levels only increase slightly in type 2 diabetics and the symptoms may not develop until the ketoacidosis becomes severe.
Ketoacidosis symptoms may include:
Pain in the abdominal area
Feelings of confusion
Nausea and vomiting
Abnormal sleepiness or fatigue
Since linking Invokana and other SGLT2 inhibitors to serious complications such as ketoacidosis, the FDA has required the class of drug manufacturers to make changes to their side effect warning labels adding the risk of diabetic ketoacidosis.
Have You Sustained Injuries or Severe Discomfort Due to Medications? An Invokana Lawsuit Attorney Can Help
If you have suffered harm due to any medical devices or medications, such as Invokana, it is essential that you retain experienced Invokana lawsuit attorney right away. At The Carlson Law Firm, our product liability lawyers understand how difficult life can become when a person suffers health problems due to a specific product or medicine. That is why we are here to provide victims with quality representation. When you call our firm, we take the time to understand the details of your case and may be able to help you pursue financial compensation for your harms, lost wages, and emotional distress.
Get in touch with a Texas product liability attorney from The Carlson Law Firm today for your free Invokana Lawsuit consultation. We represent clients across the nation.
- Written by Jill Fowler