SGLT2 Inhibitors Lawsuit
A rare but debilitatingly serious infection called necrotizing fasciitis of the perineum, or Fournier’s gangrene, may affect diabetes patients taking a class of type 2 diabetes medicines called socium-glucose cotransporter-2 (SGLT2) inhibitors. These medicines, which help the kidneys remove sugar from the body, include brands like Invokana, Faxiga, Jardiance, Invokamet, Glyxambi, Synjardy, Xigduo XR and Streglatro.
In August 2018, the U.S. Food & Drug Administration (FDA) put out a warning to diabetes patients about this risk. So far, there have been 12 cases of Fournier’s gangrene reported in patients taking an SGLT2 inhibitor from March 2013 to May 2018.
The Birmingham pharmaceutical lawyer team at Pittman, Dutton & Hellums is currently available for consultations with diabetes patients who have experienced Fournier’s gangrene, possibly as a result of SGLT2 inhibitors. We represent clients from all over the country and can help you or your loved one. Medical patients deserve to be safe and protected when they take medicine, but sadly, harm by pharmaceutical companies is something we see all too often.
If you think you might need legal representation, get in touch online for a free no-obligation consultation today, or call toll-free at (866) 722-0250.
Latest Known Facts:
- Since 2015, the FDA has released several warnings about SGLT2 inhibitors: Invokana and Invokamet include warnings about bone fracture risk and decreased bone mineral density, and in 2016, the drugs were found to increase risk of leg and foot amputations
- In 2015, the FDA revised lables of SGLT2 inhibitors to include warnings about serious urinary tract infections and too much acid in blood
- In 2016, the FDA strengthened kidney warnings for SGLT2 inhibitors, including Invokana, Invokamet, Farxiga and Xigduo XR
- Only six cases of Fournier’s gangrene (all in men) were identified in the review of other antidiabetic drug classes over more than 30 years
Gangrene is a condition in which body tissue is dying or is dead. A lack of blood flow or a bacterial infection is the cause.
With Fournier’s gangrene, an infection affects the scrotum and testicles, penis or perineum. The dead or dying tissue that is found in the genitals can extend to the thighs, stomach and chest.
Fournier’s gangrene can affect men, women or children. While men are 10 times more likely than women to have it, in the FDA cases where Fournier’s gangrene is linked to SGLT2 inhibitors, seven men and five women have had the condition. Patients with diabetes are among those who are more likely to get the disease.
Symptoms of Fournier’s gangrene to be aware of include:
Anemia, a blood condition whose symptoms include fatigue
Crackling sound when touching the genital or anal area
Dehydration, including thirst or a dry or sticky mouth
Genital or anal pain and swelling
Unpleasant odor coming from the genital or anal area
If you have diabetes and experience any of these symptoms, consult with a doctor immediately. Especially if you are taking SGLT2 inhibitors, you could be suffering from Fournier’s gangrene.
Of all the cases reported to the FDA involving SGLT2 inhibitors and Fournier’s gangrene, all 12 patients were hospitalized and required surgery. Patients with Fournier’s gangrene will need to start immediate treatment with broad-spectrum antibiotics (including those given by IV), discontinue the SGLT2 inhibitor, monitor blood glucose levels, and get alternative treatment for gylcemic control. Surgery to remove the dead and dying tissue is a possible treatment, in which reconstructive surgery may follow.
As seen from the hundreds of lawsuits that have been filed against Invokana since 2015, it’s all too common for prescription drug companies to release products to market without proper testing. When pharmaceuticals cause patients severe pain and the need for additional surgeries (which carry plenty of inherent risks, as well), the lives of patients who are in treatment for one condition can be dramatically impacted because of the negligence of drug companies. Missing time off work, having to spend time in a hospital, and having one’s body completely altered forever are just a few of the serious consequences of pharmaceutical negligence.
Invokana is just one company that has been accused of failing to adequately warn doctors and patients about known dangers. In some cases, the manufacturer has been accused of withholding critical information from the FDA.
At Pittman, Dutton & Hellums, we’re in your corner. We have years of experience going after big pharmaceutical companies that put patients in danger. We can help you or a loved one who has suffered because of SGLT2 inhibitors or other drugs.
Call us toll-free at (866) 722-0250, or contact us online for a free SGLT2 inhibitor lawsuit consultation.
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