The Food and Drug Administration (FDA) has recently looked into the Johnson & Johnson (J&J) prescription drug Invokana and came to a startling conclusion: Invokana increases a patient’s likelihood of requiring amputation surgery. J&J has been ordered by the FDA to immediately update its warning labels to include mention of foot and leg amputation risk. This is sometimes referred to as a “black box” warning label among pharmacists, doctors, and drug manufacturers.
Invokana is marketed as a diabetes drug that helps patients regulate blood sugar and otherwise reduce the negative health conditions caused by type 2 diabetes. The FDA conducted two separate clinical trials to ensure any results gathered in one trial could be compared to another and deemed reliable. It found that patients who took doses of canagliflozin – the drug of which Invokana consists – were about twice as likely to need a leg or foot amputation as patients given a placebo, or sugar pill.
The amputation rate in Invokana users was calculated at about 0.6% whereas the same rate for placebo users was calculated just under 0.3%. However, the secondary trial saw increases in amputation rates for both subject groups. Invokana amputation rate rose to 0.75% and placebo amputation rate spiked to over 0.4%. The difference between both subject groups in each test is still noticeable enough to reach the conclusion that Invokana is increasing amputation risks.
Patient amputations that were recorded during the clinical trials included:
- Toes
- Mid-foot
- Below the knee
- Above the knee
If type 2 diabetes is untreated or advances despite treatment, it could result in the patient becoming blind, suffering nerve damage, experiencing kidney failure, or developing a cardiac disease. The FDA’s report on Invokana’s amputation risk did not explicitly comment on the drug’s influence on either preventing or causing these side effects.
If you or someone you love have suffered injury or illness due to being prescribed a dangerous drug, you can speak to a Kansas City product liability attorney at Bertram & Graf, L.L.C. to learn what to do next. With our legal guidance and advocacy, you may be able to file a claim against the drug manufacturer – Johnson & Johnson in the case of Invokana – for fair and maximized compensation. Contact us today to schedule a free case evaluation, and be sure to ask about our contingency fee agreements.