The agency required the warnings after two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana (canagliflozin), as those given a placebo. The FDA announcement came May 17, 2017, along with a posting on its website.
FDA Boxed Warning
The FDA said the warnings include a boxed warning, which is reserved for the most serious possible adverse events.
Diabetes Drug Invokana
Invokana is part of a newer class of type 2 diabetes drugs called SGLT-2 inhibitors. These drugs are promoted to help remove excess blood sugar through urine. Other drugs in the class include AstraZeneca’s Farxiga and Eli Lilly’s Jardiance.
Amputation Risk Doubles for Invokana – Study
The FDA noted that results of one clinical trial showed the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000 in a year’s time, compared with 2.8 out of 1,000 for patients given a placebo drug.
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.
Diabetes Drug Raises Risk of Foot, Leg Amputations
The FDA said amputations of the toe and middle of the foot were the most common, but that partial leg amputations also occurred below and above the knee.
The National Diabetes Statistics Report from 2017 said that some 23.1 million people – or 7.2% of the U.S. population – had diagnosed diabetes. The total included 132,000 children and adolescents younger than 18; 193,000 children and adolescents younger than 20. About 5% of people with diabetes are estimated to have type 1 diabetes.
Among U.S. adults 18 or older, data for 2013–2015 indicated American Indians/Alaska Natives had the highest prevalence of diagnosed diabetes for both men (14.9%) and women
(15.3%) Prevalence varied by region, from 6.0% among Alaska Natives to 22.2% among American Indians in certain areas of the Southwest.
Overall, prevalence was higher among American Indians/Alaska Natives (15.1%), non-Hispanic blacks (12.7%), and people of Hispanic ethnicity (12.1%) than among non-Hispanic whites (7.4%) and Asians (8.0%). Among Hispanics, Mexicans had the highest prevalence (13.8%), followed by Puerto Ricans (12.0%), Cubans (9.0%), and Central/South Americans (8.5%).
Among Asians, Asian Indians had the highest prevalence (11.2%), followed by Filipinos (8.9%), and Chinese (4.3%). Other Asian groups had a prevalence of 8.5%. Prevalence varied sharply by education level, which is an indicator of socioeconomic status. Specifically, 12.6% of adults with less than a high school education had diagnosed diabetes versus 9.5% of those with a high
school education and 7.2% of those with more than a high school education.
Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease.
Invokana Lawsuit Help
Anyone who has taken Invokana and suffered an amputation could be eligible for financial compensation for pain and suffering, loss of income and quality of life. Contact an experienced drug injury attorney now for a free legal consultation.