Raleigh Invokana and the Food and Drug Administration
Invokana was first approved for use in March of 2013 but the FDA gave Johnson & Johnson approval to begin marketing it in August of 2014. The FDA required Janssen Pharmaceuticals to perform clinical testing about its efficacy and potential side effects, and continuously monitor adverse event reports while the drug is on the market, including patient complaints about different side effects they might experience while taking Invokana. Updates from ongoing clinical trials are revealing that there may be a greater risk of a cardiovascular event for people taking Invokana. An experienced dangerous drugs lawyer can help clarify concerns a patient may have regarding Raleigh Invokana and the Food and Drug Administration.
FDA Invokana Investigations
In May of 2015, FDA issued to public health advisory linking Invokana to diabetic ketoacidosis, a condition where a diabetic person’s body produces an excess of blood acids called ketones. In December 2015, the FDA required Janssen to update the warning label to include ketoacidosis by June of 2016. The FDA then issued a safety communication concerning Invokana use and acute kidney injury, and later required Janssen to update the warning label with language about the risk of acute kidney injury.
Awareness of Medical Dangers
When healthcare professionals are overseeing a clinical trial, the information they collect may be transmitted to the FDA. In addition, adverse incident reports from patients or physicians give the FDA information about what sorts of complications are occurring in people who use a drug.
Warnings about Invokana from the FDA include the safety announcements regarding diabetic ketoacidosis and acute kidney injury and the corresponding label changes the Raleigh Invokana and the Food and Drug Administration required the manufacturer to implement to warn about the risks of those side effects.
Understanding Associated Side Effects
There are multiple trigger dates concerning when patients knew or should have known about the associated side effects. If somebody took Invokana before December of 2015, there was no mention of diabetic ketoacidosis. If they subsequently suffered from diabetic ketoacidosis, they were not properly warned about it, which could mean they are eligible to file a claim against the manufacturer.
Role of an Invokana Injury Attorney
The FDA’s role is to collect information from clinical trials and from patients to determine if there is a significant increase in a certain type of injury or other health risk associated with using the medication.
If the FDA finds reason to believe there is, they are to alert the public through safety communications and require the manufacturer to update their warning labels, or include a black box warning about any issues with the drugs, so that patients are aware of the dangers.
Claims often arise when the results of clinical trials are released after a drug has already been approved. The canvas study for Invokana revealed a 600 percent increase in cardiovascular event risk within the first 30 days of use of. The results of that study were not released until after the drug was approved for sale. Contact an attorney for more information on Raleigh Invokana and the Food and Drug Administration.