Invokana & Ketoacidosis
Invokana is a type 2 diabetes medication. Many users developed a condition called diabetic ketoacidosis after using it. Recently, a wrongful death lawsuit was filed by the family of a Florida woman who allege the medication led to her fatal stroke. According to Frederick Robinson, his wife Cheryl died from a stroke in April 2015, after beginning her Invokana prescription in July 2014. The lawsuit references the multiple of adverse event reports filed with the FDA related to Invokana. Robinson’s case is one of several filed in the last few months. In December 2015, the FDA required Johnson & Johnson to update its packing to include a diabetic ketoacidosis warning.
A full set of clinical trials focused on confirming the medication’s ability to decrease potentially dangerous HbA1c levels in the blood. The drug proved effective, especially when used in conjunction with other diabetes control medications, resulting in tentative FDA approval in 2013. Johnson & Johnson spearheaded the marketing campaign to physicians under their Janssen division. The potentially deadly ketoacidosis side effect risk did not appear until well after this drug hit the market. Comprehensive research studies seem to confirm that the increased risk of developing renal damage, cardiovascular issues or systemic infections links directly back to this medication.
In response to the continued reports of ketoacidosis, the FDA decided to update the warning label for Invokana to include this potential side effect in 2015. The development of ketoacidosis floods the vascular system with ketone acids, which actively change the pH of the patient’s blood. Over time, the ketone overload and pH changes can damage the patient’s heart and kidneys, potentially resulting in death.
The FDA warned that patients should watch for the following symptoms:
- Nausea and Vomiting
- Stomach Pain
- Difficulty Breathing
- Mental Confusion
- Acetone Scented Breath
If patients notice any of the telltale symptoms, it is important to seek medical care immediately to avoid organ damage and fatal complications.
Patients who developed ketoacidosis from taking Invokana promptly acquired care at a nearby medical center to fully recover from the illness. Since the patients immediately sought medical assistance, there have been zero deaths attributed to ketoacidosis caused by Invokana. Since ketoacidosis from other causes does take lives every day, the chance of patients developing fatal complications remains, especially if these individuals are not warned about the risks. During treatment of ketoacidosis, patients had to cease taking the SGLT-2 inhibitor medication and rely on alternate methods to control their type 2 diabetes symptoms. Since diabetic patients cannot control their symptoms with dietary changes or regular exercise, many experienced uncontrolled blood sugar levels while seeking and testing alternative medications.
Road To Approval
Since Invokana is a relatively new diabetes medication, the FDA only offered conditional approval to the marketing team at Johnson & Johnson. This company was required to prove that the medication did not increase the potential for patients to develop cardiovascular problems. To determine the safety of the drug, several groups completed detailed studies about its cardiovascular, renal and infection risks.
Unfortunately, the drug performed poorly across the board. During an FDA review of the medication’s research performance, it revealed that patients faced a staggering 46 percent increased the risk of stroke while undergoing treatment with Invokana. Patients also had a significant risk of experiencing a cardiovascular event during the first month of therapy. Since the study indicated that the risk markedly decreased after that point, the drug won approval by the FDA.
Safety Group Warnings
As a part of the continued monitoring, independent groups, like The Institute for Safe Medication Practices, added Invokana to their list of medications to watch. In their May 2015 issue of Quarter Watch, this group shared their findings that indicated a high 92 percent risk of adverse effects from this drug, as compared to the similar medications on the monitoring list.
Physicians also filed all side effects experienced by patients on this medication. In a single year, nearly 500 incidents were reported with close to half of them centered around renal damage. Of the renal damage reports, about one-quarter represented total and partial kidney failure. Kidney stones, infections, and scarring also were mentioned.
As previously indicated in initial clinical trials, patients also reported the propensity to develop symptoms of an allergic reaction. Symptom severity ranged from mild to severe with many patients reporting the rapid development of rashes and swelling without any warning whatsoever.
Seemingly vague symptoms, like unexplained weight loss and fluid imbalances, often precluded advanced side effects. When these symptoms did not cease nor advance with the appearance of severe conditions, like ketoacidosis, the link between the drug’s grave and mild side effects was made.
Kidney Damage Lawsuits
The bulk of the lawsuits filed by lawyers representing patients injured by Invokana addresses kidney damage. The fact that the manufacturer may have failed to warn patients and physicians about the high risk of permanent kidney damage give the lawsuits a fighting chance in court.
Evidence presented in court may need to reveal that Janssen Pharmaceuticals, a division of Johnson & Johnson, willingly deceived the general public into believing their medication was safe and efficient. In addition to the results of human studies, legal representatives can use animal research results that linked long-term Invokana usage with irreversible kidney damage and cancer. If the court system sides with the patients, compensation for pain and suffering, bodily injury and lost, wages could be possible.
If you developed ketoacidosis after sustained diabetic therapy with Invokana, you might be eligible to file or join a lawsuit against the drug manufacturers. Upon meeting with an attorney, your case will receive a full review to determine eligibility and the extent of the damage. Your attorney will also calculate losses associated with the debilitating side effects caused by this SGLT-2 medication.
Your claims against Invokana manufacturers may highlight their improper warning system for potential side effects or negligence in producing a harmful drug. Your case may be bolstered by claims that the manufacturers skewed data or otherwise misrepresented their formula to indicate its suitability as a long-term diabetic treatment. As with all lawsuit claims, the time continues to run down for patients looking to seek compensation for their injuries through the court system. You must promptly file your lawsuit with the appropriate court to avoid missing the chance to apply for reimbursement for your damages.
Since the current drug remains on the market, lawsuits against the medication manufacturers will likely continue to arise as patients suffer adverse effects. Future settlements will help develop a precedent that legal representatives may use in court to bolster their case as they seek compensation for their clients.
- http://www.njlawjournal.com/id=1202753894911/Suits-Take-Aim-at-JampJ-Diabetes-Drug-Invokana? slreturn=20160308180702