Parker Waichman LLP, a national law firm representing plaintiffs, is closely following Xigduo XR for its potentially devastating side effects.
Type-2 diabetes is emerging as one of the most significant health problems of our time. In the U.S., almost 29 million people have Type-2 diabetes. The worst part about that statistic is that the Centers for Disease Control (CDC) estimate that 25% of the people who have Type-2 diabetes are unaware they have it. The number will rise as children and adults alike become more sedentary with the advent of more sophisticated technologies requiring people to move less overall and a societal shift away from a communal society to a more individualized society marked by those same technological advances. The result? More and more instances of Type-2 diabetes occurring in the U.S.
The escalating number of Type-2 diabetes cases is fertile ground to cover for drug makers who wish to flood the market with medications purportedly designed to combat this insidious disease. The CDC theorizes that over 80 million people aged 20 or older have a condition medical experts call “prediabetes.” Naturally, drug companies large and small desire to rush products to the market to address the diabetic pandemic. However, in their over-exuberance to send a new diabetic drug to market, they have failed to thoroughly study the possible side effects the long-term use of these new drugs could have on a person with diabetes.
This class of drugs, called sodium-glucose cotransporter inhibitor-2, or SGLT2, was designed by some of the largest drug manufacturers around today. Names like Johnson & Johnson, Eli Lilly, AstraZeneca, and Bristol-Meyers Squibb have designed SGLT2 drugs and entered the market at various points in time from 2011 to 2015.
Xigduo XR (dapagliflozin and metformin hydrochloride, extended-release) is the latest offering from AstraZeneca. Xigduo XR combines the SGLT2 drug dapagliflozin and metformin, which is a diabetes drug that has been on the market for almost a decade. The U.S. Food and Drug Administration (FDA) approved Xigduo XR for consumer use in 2014. Since then, all SGLT2 drugs have come under scrutiny from medical safety agencies such as the FDA in the U.S. and the European Medicines Agency (EMA) because of the potential for every SGLT2 drug to lead to lower extremity amputations.
Parker Waichman LLP is a national law firm who is dedicated to finding justice for victims of large drug manufacturers. Parker Waichman LLP’s Xigduo amputation attorneys understand the significance of your claim and know how to build your case so that you have the best opportunity to recover sufficient financial compensation to ease your burden as you try to adjust to your new life, one you did not choose.
Potential Threat Posed by Xigduo XR
While there have not been any specific reports from patients that they have lost a limb from taking Xigduo XR, it is a relatively new drug, and the possibility remains that before long people who take Xigduo XR might complain about significant and life-altering injuries. Xigduo XR is a drug similar to, but not identical to, Invokana. Invokana was linked to amputations of the lower extremities. Most amputations were confined to the toe. But, many people faced the specter of losing their entire foot, or even their leg from the knee down to Invokana, an SGLT2 class drug.
The FDA seems to be taking this situation on a case-by-case basis. To this point, the FDA ruled that Invokana, and only Invokana, must contain their “Black Box Warning” cautioning consumers and physicians alike that taking Invokana increases the risk of suffering an amputation. The EMA has taken a different approach. It is an approach based on common sense and a compelling need to protect the public from bearing the tremendous loss, indignity, and scarring left by an amputated limb.
In February of 2017, the EMA issued a warning to the public that all SGLT2 drugs should be used with extreme caution. The EMA reasoned that to that point that while Invokana was the only drug to have been connected with amputation, all SGLT2 medicines worked in a nearly identical manner. Additionally, the chemical composition is also very, very similar. Therefore, the EMA quite admirably reasoned, that until exhaustive testing has been performed and scrutinized by peer review, every person with Type 2 diabetes who is taking an SGLT2 drug should be aware of the potential for the drug to cause an amputation.
It remains to be seen whether patients who take Xigduo XR to control their diabetes will suffer the indignation of losing a limb. That being the case, Xigduo XR is not without its potentially life-threatening side effects. The FDA required AstraZeneca to post a Black Box Warning on Xigduo XR before the agency approved consumer use of the drug calling attention to the fact that Xigduo XR can cause lactic acidosis.
Lactic acidosis is a potentially fatal condition. The FDA warns that a patient who is presenting to the hospital suffering from lactic acidosis to hospitalize that person immediately. Lactic acidosis can result in respiratory distress and congestive heart failure. Lactic acidosis occurs when metformin builds up in the body.
The critical point here is that a person whose physician prescribed Xigduo HR knows before they begin taking the drug that it could cause a serious medical issue. Xigduo HR contains no equivalent warning about amputation. Therefore, patients in the U.S. are left to guess whether they will suffer the same fate as those unfortunate people who took Invokana and lost a limb.
Contact Parker Waichman LLP Today to Discuss Your Potential Xigduo XR Lawsuit
At Parker Waichman LLP, our Xigduo XR amputation lawsuit attorneys vigorously pursue damages for our clients who were injured through no fault of their own. If you or a family member suffered a severe injury from taking an SGLT2 drug manufactured by any of the drug makers listed above, call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) or use our contact form.
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