Will the FDA Recall Invokana, Farxiga, Jardiance or Other SGLT2 Diabetes Drugs?
Since the new-generation diabetes hit the market in March 2013, a number of serious safety concerns have emerged over the potential side effects of Invokana, including a risk of leg and foot amputations, diabetic ketoacidosis and kidney failure.
As information has come to light, many individuals have raised questions about whether the minimal benefits provided by the medication are outweighed by the risk, and whether an Invokana recall should be issued to protect consumers.
Many diabetes patients placed on Invokana have suffered severe and often life-threatening injury, which may have been avoided if another drug had been prescribed. However, it is unlikely that the FDA will remove Invokana from the market, as stronger warnings can likely address many of the safety concerns and avoid the need to recall Invokana and other SGLT2 inhibitors entirely.
With additional information about the potential Invokana injury risks, doctors and users will be armed with accurate and sufficient information to decide for themselves whether to use the medication.
In May 2015, the FDA issued a drug safety communication warning about the Invokana diabetic ketoacidosis risk, indicating for the first time that a large number of adverse event reports have been received from users of SGLT2 inhibitors since Invokana hit the market.
On December 4, 2015, the agency announced that it was requiring new label warnings on Invokana and similar diabetes drugs, which would warn patients to stop using the drug immediately and seek medical assistance if they began experiencing signs of ketoacidosis.
Diabetic ketoacidosis involves high acid levels in the blood, which may cause symptoms like nausea, vomiting, severe abdominal pain, dehydration, difficulty breathing, low blood pressure and heart problems. While diabetic ketoacidosis is often linked to type 1 diabetics, these reports were coming in from type 2 diabetics using Invokana and other similar drugs. All of the cases the FDA investigated resulted in the consumer being hospitalized, and users may be able to avoid serious consequences in the future if they are aware of the importance of monitoring for early warning signs of ketoacidosis.
The same month the FDA first announced that they are reviewing the diabetic ketoacidosis warnings, a report published by the Institute for Safe Medication Practices (SMP) highlighted a potential link between Invokana and kidney failure, identifying incidents where users experienced kidney failure, kidney impairment, kidney stones, urinary tract infections, fungal infections, dehydration, hypersensitivity and unusual weight loss.
The ISMP openly questioned whether Invokana should remain on the market, suggesting that the drug’s risks may outweigh any benefits. However, at a minimum, information about the kidney risks should be added more clearly to the warning label.
Concerns about potential amputation risks were raised by the FDA in May 2016, following a number of studies that raised alarms in the medical community. In May 2017, the FDA announced that new label information about the Invokana amputation side effects would be placed prominently in a “black box”, which is the strongest warning that can be required for a prescription medication.
Strengthened warnings may have a similar impact to a recall, as Invokana may not be considered a safe or effective treatment option when users are aware that they may face an increased risk of diabetic ketoacidosis, amputation problems, kidney failure or wrongful death.
Invokana Recall Lawsuits
As a result of the drug makers’ decision to place their desire for profits before consumer safety, withholding information and warnings from consumers, former users have pursued financial compensation through an Invokana injury settlement.
Allegations raised in complaints filed nationwide indicated that Johnson & Johnson’s Janssen unit should have provided stronger warnings or recalled Invokana once reports of kidney failure, amputations, ketoacidosis and wrongful death began to surface among users of the drug.
If warnings had been provided, many users may have avoided serious injury by choosing not to use the new type of diabetes drug, which provides little, if any, benefits over other available treatments for most diabetics.
At this time, our Invokana attorneys are only reviewing additional cases for individuals who required an amputation following use of this medication. To find out whether you or a loved one may have a case, request a free consultation and claim evaluation.