Invokana Amputation Lawsuit
Invokana (canagliflozin) is an oral medication used to control high blood sugar in patients diagnosed with type 2 diabetes. Doctors prescribe Invokana to reduce the risk for many of the most common complications associated with type 2 diabetes including blindness, kidney damage, nerve problems, sexual function, and loss of limbs.
Invokana is part of a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors that work by increasing the removal of sugar through urine that is naturally caused by the kidneys.
There is now evidence that Invokana could trigger more severe side effects. The US Food and Drug Administration (FDA) recently issued an alert to the public that there has been an increase in the need for leg, foot, and toe amputations for patients using Invokana. The alert comes after interim safety results from a long-term, ongoing clinical trial identified an increased risk of amputations in patients using Invokana.
Clinical Trial Shows Higher Risk of Amputation for Invokana Users
During the ongoing Invokana clinical trial, researchers identified an increased risk for foot and leg amputations, many of which specifically affected the toes. Amputation procedures were needed in twice as many patients treated with Invokana compared to those treated with a placebo. Over the course of one year observing 1000 test subjects, the interim analysis showed a need for amputation procedures for:
- 7 subjects taking 100 mg a day of Invokana
- 5 subjects taking 300 mg a day of Invokana
- 3 subjects taking only the placebo
The study is currently in its fourth year and is expected to continue following the recommendation of the independent data monitoring committee. There is also another trial underway evaluating the drug ongoing that has not produced the same results, however, that study has been observing patients for approximately nine months.
More Research Needed before Drawing a Direct Link between Invokana and the Need for Amputation
The FDA stopped short of stating that Invokana is directly the cause of higher rate of leg and foot amputations, but has decided to investigate further whether or not there is a link between occurrences and the drug.
Patients should alert doctors of any concerns if they are using Invokana. They should not immediately stop using the medication without their doctor’s consent because doing so could trigger a harmful blood sugar episode.
Users of Invokana are also encouraged to alert their doctors to any unusual symptoms, especially if the symptoms involve sores, ulcer, or infections, or if their legs, feet, or toes feel tender or painful. Doctors should monitor patients for these symptoms and determine the risk for patients currently using Invokana.
The FDA stated in its warning that it is continuing to evaluate the new information and will provide more information to the public once it is available. They also ask that patients and doctors report any issues with Invokana, especially those related to amputation, to their MedWatch program.
Original Source: http://www.fda.gov/Drugs/DrugSafety/ucm500965.htm
Additional Source: http://www.webmd.com/drugs/2/drug-163874/invokana-oral/details