FDA Announces Invokana is Linked to Amputations
The FDA announces that a diabetes drug, canagliflozin (Invokana) was linked to leg and foot amputations when it comes to an ongoing post-marketing trial.
Overview of the Invokana Announcement
Accoridng to Medpage Today, canafliflozin, which is a sodium-glucose transporting inhibitor, was being tested in a cardiovascular (heart and blood vessels) trial, known as CANVAS to determine the safety of the drug.
The increased risk was realized when amputations occurred about twice as often on canagliflozin patients. The absolute risks of amputations varied while on the drug as follows:
- 7 out of every 1,000 patients on 100 mg daily
- 5 out of every 1,000 patients on 300 mg daily
- 3 out of every 1,000 patients on the placebo
The agency has stated they have not yet determined whether canagliflozin is to blame for the increased number of amputations. Researchers have been tracking these trial patients for an average of 4.5 years. They reported that another trial evaluating the drug does not indicate an increased risk of amputation. The patients were only followed for an average of 9 months, however.
The FDA claims they will continue to monitor the data, and recommended that health professionals follow the labels on the drug and monitor their patients for signs.
Information on the Drug Invokana
Provided by Drugs.com:
- Invokana (canagliflozin) is an oral diabetes medication that helps control blood sugar levels.
- Works by helping the kidneys get rid of glucose in your bloodstream.
- Can treat type 2 diabetes, but not for the treatment of type 1.
- Side Effects of Invokana: Lightheadedness, pain or burning when you urinate, signs of a genital infection, slow heart rate, nausea, kidney problems, dehydration symptoms.