Invokana and Fournier’s Gangrene
September 29, 2018 | Pharmaceutical Litigation
When you take a medication prescribed to you by your health care provider to treat a condition, you usually expect some side effects. You usually do not think about the medication killing you faster and in a more painful way than the condition you are trying to treat. However, for some unlucky souls taking Invokana, this is what happens when they end up developing a condition known as Fournier’s gangrene.
What is Fournier’s Gangrene?
Fournier’s gangrene is classified medically as an acute necrotic infection of the scrotum, penis, or perineum. It is characterized by scrotum pain and redness with rapid progression to gangrene and sloughing of tissue. Fournier gangrene is usually occurs with perirectal or periurethral infections that has been caused by local trauma, operative procedures, or urinary tract disease.
“Since 1950, more than 1,800 cases for study have been reported in English language medical literature. This disease occurs worldwide and, although it is recognized more frequently among male adults, has been identified also among women and children. Treatment usually consists of the surgical removal (debridement) of extensive areas of dead tissue (necrosis, necrotic) and the administration of broad-spectrum intravenous antibiotics. Surgical reconstruction may follow where necessary” (National Organization for Rare Disorders).
Signs and Symptoms to Look Out For
Symptoms of this terrifying condition include fever, general discomfort, feeling of malaise, moderate to severe pain in the penile area, and swelling in the genital and anal areas. As the infection spreads, it is followed by rankness and smell of the affected tissues and ultimately ends with a full-blown case of rapidly spreading gangrene. Rubbing the affected creates a unique sound known as crepitus, which is the release of gas in the wound and another distinct sound known as palpable crepitus, which is crated as tissues moving against one another. In severe cases, the death of tissue can extend to parts of the thighs, through the abdominal wall and up to the chest wall.
This disease is commonly found in conjunction with other disorders (comorbidity) and those conditions that affect the immune system, nervous system, and circulatory system seem to contribute the most to development of Fournier gangrene. Some disorders that increase the predisposition to the condition are diabetes mellitus, profound obesity, cirrhosis, interference with the blood supply to the pelvis, and various malignancies. These conditions will not cause an individual to develop Fournier gangrene on their own but make it easier for the body to be weakened in a way that they may develop the condition. Certain medications taken for these conditions can also weaken the body and make on more prone to this infection.
what Causes the Infection?
This condition can be caused by several toxins and when the bacteria, fungi, and/or viruses responsible for a particular case of Fournier gangrene get into the body it is usually through a location that is colorectal, urogenital or cutaneous in origin. Anorectal abscesses, urinary tract infections, surgical instrumentation and other contributing factors have all been implicated. Some cases have no known cause and no clearly identifiable point of entry but this is very rare. Why this process occasionally develops in individuals with common ailments is still not understood and Fournier gangrene in general is still considered a very rare infectious disease and little is truly known abut it. What is known has been discovered in the last few decades.
Official Warnings Regarding Fournier Gangrene
If you or a loved one are currently taking the Type II Diabetes medication known as Invokana, you may want to talk to your doctor about the risk for Fournier gangrene as there are cases of users developing this disease without any other risk factors being known. The U.S. Food and Drug Administration (FDA) is 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. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.
Most Commonly Affected Populations
The average age for cases of Fournier gangrene is about 50 years, but the range of patient ages has been shown to span from a week old to more than 90 years old. Fournier gangrene is diagnosed more frequently among males as almost all cases present as necrosis infections in the scrotum and penile area. It may be that the high male to female ratio in the diagnosis is the result of the lack of recognition of this entity among women by physicians. It is believed that the male to female proportion may be anywhere from 5:1 to 10:1. There is no sufficient data available yet to determine the rate of occurrence among different ethnic groups of if other factors may exist that cause someone to develop the condition over another individual.
Diagnosis Process for Fournier Gangrene
The diagnosis is basically made on clinical findings and the following tests are the most common methods of detection and diagnosis for the condition.
- Computed tomography helps pinpoint the area of entry and extension of infection
- X-ray studies can be useful to show location and extent of gas distribution
- Ultrasonography is useful in diagnosis but ma be too painful for some patients
- Computerized tomographic scans can help pinpoint smaller gas pockets easily
Standard Therapies and Treatment
It is of the utmost importance to recognize cases of Fournier gangrene as soon as possible and to initiate aggressive resuscitation and administration of broad-spectrum intravenous antibiotics immediately. Such antibiotics must also be done along with urgent surgical debridement of all necrotic and infected skin and subcutaneous tissue involved. Follow-up removal of wound margins may be necessary to get ahead of the infection spread. Patients with severe blood infection (sepsis) are at increased risk for developing blood clots (thrombembolic phenomena) and may require medication to reduce the risk for thrombosis. Any reconstructive surgery can only be done once infection is under control.
Contact Us Today
If you or a loved one has suffered from Fournier gangrene as a result of being prescribed Invokana to treat your diabetes or you fear you are at risk for developing the condition due to negligence and poor judgement on the part of your heath car provider, contact us today! We can help you review your case and show you what legal options you have available to you. Call now for a free consultation with our legal team!
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