Brief History on Invokana
My firm knows that many drugs often fail to perform as well as their manufacturers initially claim they will. In fact, some new drugs cause dangerous medical complications that can greatly compromise or even ruin people’s lives. That’s why our firm stays open to evaluating claims that a new drug is causing serious or even potentially deadly side effects.
Janssen Pharmaceuticals (a Johnson & Johnson company)
Back in March of 2013, when Janssen Pharmaceuticals (a Johnson & Johnson company) first announced FDA approval of SGLT2 drug Invokana, patients battling Type 2 diabetes were cautiously optimistic that a promising new form of treatment had been found. With close to 25.8 million Americans currently suffering from diabetes, most new drugs are readily welcomed.
While it’s hard to find precise figures documenting how many patients have been prescribed this drug since 2013, one group of market analysts predicted that Invokana’s potential sales could reach as high $416 billion by the end of 2016 (others predicted even higher sales).
Unfortunately, Invokana’s honeymoon period didn’t last very long compared to other new drugs. Before recalling the drug’s first signs of trouble, let’s briefly review what many diabetics had hoped this drug might offer them.
What Were the Unique Offerings of Invokana?
When Janssen first began promoting Invokana, the company said it was the only once-a-day, oral medication available for Type 2 diabetics that might help them improve their systolic blood pressure and glycemic control – while also helping reduce their body weight.
In addition, Janssen claimed that Invokana could prevent a person’s kidneys from reabsorbing any glucose while also making it easier to excrete glucose during urination.
Physicians and market analysts were optimistic when told that Invokana had gone through nine clinical trials involving 10,000 patients. However, distinct side effects began appearing during those trials – including urinary tract and yeast infections. Soon, Invokana’s honeymoon period would end as the FDA and others began receiving serious patient complaints.
Reports Surface Indicating Invokana Can Be Very Harmful to Some Patients
As complaints increased, the public was told that a full third of the FDA panel members had not even voted to approve the drug – and patients were reporting many new side effects to their physicians. Furthermore, the medical community was learning that Invokana can increase patients’ chances of suffering strokes and heart attacks shortly after they start taking it.
First Warnings Issued
Drug warning issues soon came to light as the FDA discovered that many of the drug’s potential side effects were not listed on the label. And the FDA learned that patients taking the drug had an increased chance of developing chronic kidney disease and diabetic ketoacidosis.
New medical articles were also stating that Invokana can significantly increase a patient’s chances of developing genital fungal infections and amputation risks were rising.
More Warnings Issued
The FDA now felt compelled to issue special warnings about Invokana in both May and December of 2015. The first warning was based on 20 separate reports of patients developing diabetic ketoacidosis while the second one addressed this same medical condition – when hospitalizations due to this side effect began greatly increasing.
The December 2015 warning also mandated new drug labels that would clearly list all the major patient side effects being linked to the drug. The FDA remains so greatly concerned for patients taking Invokana that it now asks all of them to report any new problems directly to the government by using the MedWatch system.
Another Warning on Increased Kidney Side Effects
Finally, in June 2016, the FDA issued a new warning based on all the diabetic patient reports indicating increased kidney side effects due to this drug.
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Sacramento Drug Product Liability Lawyers
I’m Ed Smith, a Sacramento Invokana Injury Attorney. If you or a loved one has suffered any of the above side effects after using Invokana, please call me today at (916) 921-6400 or (800) 404-5400 for free, friendly advice.
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Image Attribution: Invokana Injury Lawyer, Edward A Smith
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