The medication "Invokana" or canagliflozin has been prescribed for patients dealing with diabetes.
However, the FDA was stringent about how it was tested and what information was put on the labels before offering it to the public. This information came out recently after two large clinical studies were run by the FDA on Invokana and its response once in the body. The U.S. FDA has issued a recall of this drug.
The studies were clear about how the medication reacted and what it did to the body once it was consumed. This read is going to take a look at the connection made by the studies done by the FDA.
Type 2 Diabetes
Patients with Type 2 Diabetes are put in a difficult situation while requiring treatment and need to make sure they are targeted with a good solution instead of one that's unsafe.
This is one of those unique options that can generate positive results and can help reduce the symptoms a patient may have when it comes to this condition. Instead of letting it continue, it is better to look at targeting diabetes and making a positive change.
However, the FDA was particular about what the drug did to its patients and emphasized the risk.
The studies were done on a large group in a bid to see if there were variations in how the body would respond if it were to be given canagliflozin or something else (i.e., placebo).
In the end, the studies were conclusive about the connection between canagliflozin and amputations. The studies showed the body was more likely to require a leg amputation if canagliflozin was taken by the patient. The difference was a 3% increase.
While the initial risk is low, the 3% increase in a larger group is still a significant one for the FDA and its specialists. This is why the boxed warning is necessary.
The findings were apparent when it came to the drug and its bodily response once ingested.
The studies revealed the body would see an increased risk when it came to amputations. Due to how the drug would maximize the body's systemic responses, it would end up also heightening the risk of needing an amputation for those ingesting it on a regular basis.
While this risk was not being seen in 100% of patients, it was present in a large enough sample size to make it a noticeable side effect while treating Type 2 Diabetes.
The drug now requires a boxed warning as listed by the FDA. For more information visit https://www.yourlawyer.com/invokana-lawsuit-attorneys/ to see if you have a Invokana claim.
This warning is not optional and is legally required for the medication to be sold in the US at any given moment. This boxed warning is a result of the clinical studies and how patients responded to the drug regardless of their condition. While the drug is useful and offers a plethora of advantages, this still has to be noted as a warning.
Having the warning is a must when it comes to determining how the body will respond and what may happen if a patient were to take the correct dosage.
The warning is done to prepare patients and physicians when it comes to canagliflozin.
Being able to respond to the symptoms as soon as they arise eliminates the necessity of dealing with significant consequences that are life-altering. If the physician can keep note of how the body is responding, it becomes easier to manage the condition and still see results with the underlying treatment. This is what the FDA has enlisted after running the studies and noticing the pattern. The immediate discontinuation is an important example of the options available to both parties.
While the FDA run two clinical studies on a large group to see the variation between placebo and Invokana, it was important to think about the studies later down the road. The FDA has enlisted the boxed warning but is also asking physicians to keep an eye out for additional symptoms that are arising in their patients.
The medication has proven to be effective, and that is a plus point when it comes to the treatment regimen.
Being able to rely on the studies illustrates what the medication brings to the table and why it is still required.
Amputations are not a good sign and something most patients are afraid of when it comes to Type 2 Diabetes that this is still an important drug in the treatment regimen and remains a viable solution. The boxed warning is a good way to stay on top of things and is listed to keep people aware of what they are taking. The FDA still has approved the drug and believes it is one of the most effective solutions for Type 2 Diabetes in its current state. The side effects are there but can be managed with care.
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