Reports show that foot problems related to diabetes including amputation may be worsened in patients using Invokana and Invokamet.

Invokana and Invokamet are two drugs in a class of diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs are used to treat type-2 diabetes by helping to lower blood sugar. They do this by causing excess sugar to be expelled from the body in the user’s urine.

Though these drugs can help many people manage their diabetes, they may have some serious side effects. The FDA recently released a warning to medical professionals and the public that SGLT2 drugs like Invokamet and Invokana can increase a diabetic patient’s already elevated risk of limb amputation, particularly in the case of leg and foot amputations.

Foot problems related to diabetes can seriously impact a person’s mobility and health. One concern that diabetes patients face is the increased risk of limb amputation. In general, diabetics have a higher rate of developing neuropathy, or nerve damage than people without diabetes. When someone develops neuropathy, their sensation is reduced, and they may not notice that they have injured their limbs.

Verywell Health outlined how diabetic neuropathy can lead to amputation, noting that if someone does not notice an injury, the injury can “develop into ulcers, infections, and cause tissue death.” Verywell Health goes on to note that people with diabetes often have circulation problems, which can slow healing. 

Though drugs link Invokana and Invokamet are supposed to help lower glucose levels and perhaps make it less likely that a patient will develop neuropathy and require amputation, reports show that foot problems related to diabetes including amputation may be worsened by taking Invokana and Invokamet.

In May 2017, the FDA issued a new warning about the health risks associated with canagliflozin, known by its brand name Invokana. The warning also applied to canagliflozin when it is in combination with metformin, in which case it is known as Invokamet.

The FDA will now require the boxes of those drugs to bear warnings that they may increase a patient’s risk of having a lower-limb amputation. The FDA stated that these risks were indicated in two trials. Allegedly, in two trials, patients taking canagliflozin (Invokana and Invokamet) were twice as likely to have a lower-limb amputation than patients given a placebo.

This means that patients taking the drug that was supposed to help manage their diabetes were most likely to suffer this diabetic symptom than patients taking no medication at all.

Even Janssen, the makers of the drug, released a statement acknowledging the risks associated with Invokamet and Invokana. The statement was released in September 2017 and urged medical professionals to carefully monitor the health of patients taking the drugs and to discontinue the use of Invokana and Invokamet in patients who had an elevated risk of requiring amputations.  

Some patients allege that Janssen and its parent company Johnson & Johnson may have known long before the FDA warning that these drugs were dangerous, and intentionally concealed the risk in the interest of selling more drugs. The patients believe the drug company may have knowingly imperiled the health of patients to increase their own profits.