FDA Launches New Invokana Safety Review
Recent studies about the newer class of type 2 diabetes drug, Invokana, show an increased risk of leg, foot and toe amputations. The FDA has since warned individuals and doctors to carefully watch for any warning signs that may occur while taking the drug.
Since Invokana hit the market in 2013, it has been linked to an array of serious side effects. Now, recent studies have suggested the drug’s association to yet another severe complication – an increased risk of leg, foot and toe amputations.
In a randomized, ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial, it was found that patients treated with canagliflozin were twice as likely to require leg and foot amputations. Studies like CANVAS are conducted to help evaluate the safety, tolerability and cardiovascular risk of canagliflozin. In this specific trial, more than 4,000 people were randomly selected and have been followed for an average of 4.5 years.
So far, the panel has found that the rate of amputations per every 1,000 patients was equivalent to:
- Seven for 100 mg/day of canagliflozin
- Five for 300 mg/day of canagliflozin
It’s important to also note that only three per 1,000 patients taking the placebo were affected.
The Risks Associated With Type 2 Diabetes
With diabetes affecting so many Americans nationwide, more companies are producing prescription drugs to help diabetics better control their condition. If type 2 diabetes is improperly managed, over time it can narrow arteries, damage nerves and decrease blood flow to the lower legs. Poor circulation not only prevents cuts and sores from healing, but can also lead to a dangerous infection if left untreated.
A lack of blood supply to the lower-limbs may include symptoms such as:
- Cold skin
- Chronic pain
- Skin becomes darker or black
- Injuries that do not heal
- Infections that spread rapidly
FDA Safety Communication About Invokana
Unfortunately, the recent allegations are not the first time time Invokana’s manufacturer, Johnson & Johnson, has come under scrutiny. Back in late 2015, the FDA had to update Invokana’s prescribing label to list an increased risk of ketoacidosis and urinary tract infections.
Though the FDA has not yet determined whether or not canaglifozin also increases the possibility of leg, foot and toe amputations, it has launched an investigation related to the issue. In its May 2016 Invokana safety review announcement, the agency noted that patients should not stop or change their diabetes medicines without first talking to their doctor. For now, the agency recommends health care providers monitor their patients for any signs or symptoms that could lead to a possible amputation, such as:
- Reports of new pain in the legs or feet
- Infections in lower legs
Invokana Lawsuits Stack Up
In its short amount of time on the market, Invokana has caused a host of safety concerns. With the recent news of yet another complication – the increased risk of leg, foot or toe amputations – individuals and doctors should pay close attention to any warning signs that may occur while taking the drug.
As more people experience Invokana’s adverse effects, the number of lawsuits against Johnson & Johnson will continue to grow. Most cases to date allege the manufacturer’s failure to warn consumers about the drug’s dangerous complications. Eventually, lawsuits could be brought together under one judge in a multidistrict litigation (MDL). If so, it would build a stronger case against Johnson & Johnson and expedite the legal process to help reach a solution quicker.