According to allegations raised in a new product liability lawsuit, side effects of the diabetes drug Xigduo caused a Mississippi man to suffer a life-threatening, flesh-eating genital infection called Fournier’s gangrene. The infection, which typically affects men but can also occur in women, is a form of necrotizing fasciitis that attacks the external genitalia or perineum, with rapid progression to gangrene and sloughing of tissue. The product liability lawsuit was filed by plaintiff Tommy Jones, Jr. in Delaware Superior Court on May 19, and seeks to hold AstraZeneca accountable for the company’s failure to warn about the link between Xigduo and Fournier’s gangrene. If you or someone you love has been diagnosed with Fournier’s gangrene or another potentially life-threatening side effect and you believe Xigduo to be the cause, contact an experienced Xigduo injury attorney as soon as possible for legal help.
Fournier’s gangrene is a rare but life-threatening bacterial infection affecting the tissue under the skin that surrounds the muscles, fat, nerves and blood vessels of the perineum. The infection, which spreads quickly and destroys affected tissue, has recently been linked to a widely prescribed class of diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are FDA-approved for the treatment of type 2 diabetes. Among them is Xigduo XR, a combination diabetes medication that uses metformin and dapagliflozin (Farxiga) to help adults with type 2 diabetes lower their blood sugar. Xigduo was approved by the FDA in 2014 and is currently manufactured by pharmaceutical giant AstraZeneca. Other diabetes medications that belong to the SGLT2 class include canagliflozin (Invokana) and empagliflozin (Jardiance).
Diabetes affects more than 34 million Americans and 90 to 95 percent of people in the United States with diabetes have type 2. Type 2 diabetes is a chronic condition that occurs when the body does not make or use insulin well. Without insulin to help glucose get into the cells to give them energy, too much glucose stays in the blood, which can lead to serious health problems. SGLT2 inhibitor drugs like Xigduo are commonly prescribed to adults with type 2 diabetes to lower their glucose levels by causing the kidneys to remove sugar from the body through the urine. What many of these people don’t know, however, is that SGLT2 inhibitors were recently linked to an increased risk of necrotizing fasciitis of the perineum, or Fournier’s gangrene.
In August 2018, the FDA issued a drug safety communication warning that “cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.” The infection, Fournier’s gangrene, may be rare, but the condition seems to be disproportionately associated with the SGLT2 inhibitor class of diabetes drugs. According to the FDA, there were 12 cases of Fournier’s gangrene reported in patients taking an SGLT2 inhibitor from 2013 to 2018, compared to only six cases of the infection linked to other classes of diabetes drugs over a period of more than 30 years. All 12 of those patients were hospitalized and required surgery, some required “multiple disfiguring surgeries,” some suffered complications and one patient died.
According to this new Xigduo Fournier’s gangrene lawsuit, Tommy Jones, Jr. started taking Xigduo in August 2015, and in May 2018 – just three months before the FDA’s warning – he was hospitalized with necrotizing fasciitis of the perineum, or Fournier’s gangrene. As a result of the infection, Jones required surgery and extensive post-operative care, including rehabilitation and therapy. The product liability lawsuit accuses AstraZeneca of developing, manufacturing and distributing a defective and dangerous medication without providing proper warnings about the potential for the medication to cause severe, potentially life-threatening side effects, like Fournier’s gangrene.
“Defendant knew or should have known of the significant risk of serious genital infections, including Fournier’s gangrene, caused by Xigduo, but did not adequately and sufficiently warn consumers (including Plaintiff) or the medical community of the severity of such risks,” the lawsuit states. “Indeed, Defendant conducted nationwide sales and marketing campaigns to promote Xigduo, and willfully deceived the general public (including Plaintiff) and the medical community (including Plaintiff’s healthcare providers) as to the safety and effectiveness of Xigduo.”
In addition to Fournier’s gangrene and necrotizing fasciitis, several other serious adverse health effects have been linked to SGLT2 inhibitors, including ketoacidosis, severe kidney disease and lower limb amputations. If you or a loved one took Xigduo XR for type 2 diabetes and you have since been diagnosed with Fournier’s gangrene or another serious side effect, do not hesitate to seek legal representation. You may have grounds to file a Xigduo injury lawsuit against AstraZeneca, in order to pursue financial compensation for your medical expenses, surgery, rehabilitation, therapy and post-op care, as well as your pain and suffering, lost wages and other damages. Contact a reputable Xigduo injury attorney today to explore your possible compensation options.