Invokana Amputation Lawsuit

invokana

Did you or a loved one need to undergo amputation following your use of Invokana?

Invokana (canagliflozin) is a medication used to treat type 2 diabetes. It works by removing sugar through urine, which reduces a person’s blood sugar levels. The drug is a member of a group of medications known as sodium glucose co-transporter 2 (SGLT2) drugs.

Type 2 diabetes is a chronic, controllable disease that causes a variety of severe complications, including:

  • Kidney damage
  • Blindness
  • Nerve damage
  • Sexual dysfunction
  • Loss of limbs

Invokana Users at Higher Risk for Amputation

Though some people had positive results when using Invokana, others had serious side effects.

According to a 2016 alert issued by the US Food and Drug Administration (FDA), Invokana increased the risk for leg, foot, and toe amputations in users. The FDA alert was the result of a long-term clinical trial involving Invokana that revealed the elevated risk.

This trial revealed there to be an increased risk for foot and leg amputations, most of which involved the toes of Invokana users. Nearly twice as many Invokana users required amputations as those who were given a placebo during the trial. The trial involved 1000 subjects.

According to data from the trial, which is now in its fourth year:

  • Seven Invokana users taking 100 mg per day required amputation
  • Five Invokana users taking 300 mg per day required amputation
  • Three people given the placebo required amputation

An additional trial, still underway, has not revealed the same results but has been in progress for only a little over a year. Despite varying evidence, the FDA determined a warning was necessary and issued an alert to doctors and Invokana users about the risk for limb loss.

FDA Asks for Information about Invokana from Doctors

The FDA has not stated directly that Invokana is responsible for the increase in legal and foot amputations. The two trials listed above continue to produce data, which the FDA is monitoring closely.

The FDA has requested medical professional to report any information and stated in its alert:

We are continuing to evaluate this safety issue and will update the public when we have more information. We urge health care professionals and patients to report side effects involving canagliflozin or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Health experts have yet to find a reason why Invokana might double the risk for leg and foot amputations, but some think it’s because the drug works by increasing urination, which can lead to dehydration, lower blood pressure, and reduce circulation in the feet.

Speak to Your Doctor about Any Problems with Invokana

Users of Invokana should alert their doctors of any unusual symptoms related to their legs, feet, or toes, including:

  • Ulcers
  • Infections
  • Sores

It’s also important to reduce any pain or tenderness in the lower body.

Janssen, a division of Johnson & Johnson, and the maker of Invokana have publicly stated it stands behind its drug and points to evidence from other clinical trials that the drug is safe. Type 2 diabetics are at a higher risk for limb amputation, but so far, the rate of amputation seems to be elevated for Invokana users.

Do I Have an Invokana Lawsuit?

Some users of Invokana who have been forced to undergo limb amputation are filing claims against the drug’s maker. If you or a loved one had to have a toe, foot, or leg amputated after using Invokana, you might be able to take legal action.

Claims are being filed against the maker of Invokana and more are expected to come. If you suffered the loss of a limb after taking Invokana, you should speak to a lawyer as soon as you can.

Original Source: http://www.fda.gov/Drugs/DrugSafety/ucm500965.htm

Additional Source: http://www.webmd.com/drugs/2/drug-163874/invokana-oral/details