Multiple cases of Fournier’s gangrene have been tied to diabetes medications. This condition is serious and can even be fatal. However, it is a rare condition which usually happens to men past middle age. In fact, lawsuits are being filed for the victims.
What is Fournier’s Gangrene?
Also known as necrotizing fasciitis, it affects the genital area – mainly of men. The condition is a bacterial infection that is found in the tissues under the part of the skin which is surrounding the blood vessels, fat, muscles and nerves of genitalia.
The most common people to suffer from this condition is males between the ages of 50 and 79. Only about 1.6 of 100,000 are diagnosed each year. It’s known as flesh-eating bacteria because that is what it does.
Fournier’s gangrene or genital gangrene as it’s often referred to develops when bacteria gets into the system from a tear or cut in the skin. It will spread quickly and destroys any tissue it comes into contact with. People who have diabetes are already more susceptible to gangrene because of a lower immunity system and reduced blood flow.
The Link Between Diabetes and Fournier’s Gangrene
In August of 2018, the Food and Drug Administration (FDA) provided a warning that people who were taking type 2 diabetes drugs were at an increased risk for developing this type of gangrene. The type of drugs, which are known as SGLT2 inhibitors will carry new warnings. The drugs included are:
And any generic versions.
These drugs work to lower blood sugar levels. They take away any extra glucose in the system by moving it through the kidneys and out of the body in urine. While the medications are designed for people who have been diagnosed with type 2 diabetes, they have shown to be helpful with those who have type 1 diabetes as well.
While the natural incidence rate is low, the number of people diagnosed between March 2013 and May 2018 was significantly higher with 12 cases. All were taking SGLT2 inhibitors. Five of the cases were female and seven were male. The patients were between the ages of 38 and 78 years of age. Fournier’s gangrene is rarely diagnosed in women.
According to reports, the patients developed the condition at an average of about 9 months after they began taking the medication. The actual development was from just seven days all the way to 25 months.
All of the cases required surgery for treatment with one needing skin graft surgery. All needed the infected tissue removed and five had multiple surgeries to take care of the condition. Out of the 12, four of the patients had complications from the condition. These complications included kidney injury, diabetic ketoacidosis and septic shock. One of the patients died. Two others had to go to a rehabilitation hospital.
Data was looked at for other patients who took alternative medications to reduce their blood sugar. During the period between 1984 and 2018, only six cases of the disease were diagnosed. All of the cases were men.
Treatment of the Condition
If a person is taking one of these SGLT2 inhibitors, they should pay attention if they notice swelling, redness or even tenderness of the genital area. If they have a temperature above 100.4 degrees Fahrenheit, they should seek medical attention right away. The condition can worsen quickly.
If the patient is diagnosed with Fournier’s gangrene, they will be treated with antibiotics and may need surgery. They should stop taking the diabetes medications but still monitor blood sugar levels.
The FDA has asked people who experience these or other side effects while taking the inhibitor to contact them and provide information about their case. The agency now requires a warning be included in medicine guides for patients and other information for medical personnel. It was estimated that 1.7 million patients received prescriptions for one of these drugs in 2017.
While genital gangrene has garnered attention with the SGLT2 inhibitors, this is not the only condition to be linked with the medication. Diabetic ketoacidosis is another disease which may be caused by taking the medication. It is another life-threatening condition, which requires treatment right away.
Since diabetics are more susceptible to many health conditions, experts say it is imperative that doctors are aware of these risks and educate patients on them. They need to provide information about recognizing and treating the conditions and advise them of the risk so the patient can make an informed decision about whether to take the medication.
Antibiotics May Cause IBD
A new study shows that antibiotic use for children may cause irritable bowel syndrome as adults. This study was conducted by Rutgers University and uses the correlation between young animals and their health later in life.
According to the results from the study, even short-term use of antibiotics by those under one year of age may increase the risk for developing IBD as adults. Giving infants antibiotics may cause a disruption of intestinal microbiota or the good bacteria that grows in the stomach. It helps the immune system to grow healthy and prevents diseases.
The study results strengthen the idea that antibiotic use in young children can not only prevent healthy development but it can play a part in future disease development. The study used mice which were given dextran sulfate sodium, which is a chemical known to cause problems with the colon. Some of the mice had received antibiotics while others had the normal microbial contents transplanted in the system.
The mice that received the antibiotics had more colitis and an altered response from the immune system. This study adds evidence to a hypothesis that when something disrupts the early development of microbiome, it can lead to a modern epidemic.
Researchers believe antibiotic use early in life may also contribute to type 1 diabetes later in life. It is well-known that antibiotics are designed to kill bacteria. Unfortunately, they cannot recognize the difference between good and bad bacteria, which means the medications may do harm as well as good to patients.
The Purpose of Microbiota
The human body has trillions of cells that form the microbiota in the system, which is primarily found in the intestines and stomach. These organisms are present from birth. Research indicates they make up about 4 pounds in the intestinal tract, and the mix is unique to each person.
Scientists who have studied microbiota believe that it has a major impact on how a person is able to fight off illness and disease and the way they digest food. It can even impact mood and psychological patterns.
Microbiota have been linked to many diseases, including the following:
- Heart disease
- Multiple sclerosis
In essence, the microbiota has an impact on nutrition, disease, behavior and immunity. When it is altered, it can change the way a person responds in any of these four areas.
The microbes in the gastrointestinal tract help break down nutrients in foods. For example, meat and vegetables cannot be broken down without the aid of these microbes. People wouldn’t get any nutritional value from many of the foods they eat without these little organisms.
They may also impact cravings for food and the ability to feel full after eating. Research has also shown that microbiota is more diverse in people who eat more variations in food rather than those who eat the same types of food all the time.
Further research is necessary to determine the full impact of antibiotics on the microbiota, but it could have a negative impact on people’s overall health.
FDA Adds Nearly Two Dozen Drugs to Watch List
The US Food and Drug Administration (FDA) has released a new watch list for drugs and classes of drugs. They have included almost two dozen products which may have a serious risk for side effects or new safety information has been discovered.
New Drugs to Watch For
The drugs on the list aren’t necessarily a risk for patients, but the agency believes there may be a potential problem. Further review is necessary at which point the FDA can decide to take action. These actions include:
- Require changes to the label
- Restrict use of the drug
- Remove the drug from the market
Several proton pump inhibitors were included in the list. Multiple risks were identified for this class of drug. One group had 10 different drugs that could increase the risk for SIADH or syndrome of inappropriate antidiuretic hormone secretion.
Hydroxychloroquine sulfate has received a lot of media attention lately in connection to its use in treating COVID-19. The FDA listed products that contain the ingredient because it may carry a risk for phospholipidosis. This is a condition where phospholipids build up in the tissues of the system. There is concern in patients with this condition that their liver and kidneys are functioning properly.
Also on the list is Eucrisa, otherwise known as crisaborole. This drug is used to treat mild to moderate eczema, but it may carry a risk for developing contact dermatitis. The labeling for the drug was updated to indicate this possibility.
Lipiodol was on the list for the risk of hypothyroidism, and the FDA is currently evaluating the possibility of more action. Another area of concern is with vascular endothelial grown factor inhibitors. VEGF inhibitors include Avastin, Caprelsa, Cometriq, Lenvima, and many others. They may have an increased risk for the patient to develop an aneurysm or artery dissection. The FDA is currently determining the need for regulatory action on this class of drugs.
Aimovig is another drug on the list, which may increase the risk for hypertension. This medication is used in the treatment for migraines because it can prevent the activation of a specific protein that may lead to the headache.
Belsomra may lead to falls, resulting in serious injuries. This drug has been updated with labeling that indicates the increased risk for falls. This medication is prescribed by doctors to treat insomnia.
Impavido may lead to eye disorders. It is used to treat parasites. Vasostrict, which is used to treat diabetes insipidus, may actually increase the risk of the disease. The label for this drug was updated to indicate the issue.
While these drugs haven’t been proven to cause harm to the patient, they do carry the potential for risk. Anyone who is taking these medications can talk to their doctor about the concerns they may have. The doctor may alleviate their fears or prescribe an alternative treatment. They can also stay updated by visiting the FDA website to learn about any further research or action being taken by the FDA.
Some Studies Indicate Vaccines May Stop Coronavirus
Some scientific studies indicate that current vaccines may have an impact against the coronavirus. However, other experts say that the research doesn’t provide positive proof.
It is known that some vaccines provide broader protection against illnesses than what they were originally intended for. Though they may target one type of infection or illness, they may be beneficial against other medical concerns. Some scientists are now turning to these vaccines to see if they can have an impact on the coronavirus as they wait for a new vaccine to be developed.
The vaccines for tuberculosis and polio have shown indications that they may work with the immune system to help it respond to other infections. The infections that respond include those from viruses, bacteria and parasites.
A study that has been conducted on those who have been vaccinated for childhood illnesses, such as polio, measles, mumps, and rubella as well as people who had the flu vaccine. Researchers suggest that they may have a lower infection rate for coronavirus than those who haven’t been vaccinated.
Other experts are skeptical about the findings. The paper done on the study showed that the information came from electronic health records. However, it hasn’t gone through the normal peer review process. It also hasn’t been accepted by any medical journals.
Even the critics agree that the study does provide a hypothesis that could be further investigated. At the same time, they caution that the information doesn’t prove a cause and effect situation.
Findings of the Study
The study utilized immunization records from more than 137,000 patients. They had all been tested for the coronavirus. The researchers divided them into groups of vaccinated and unvaccinated. Research showed that patients who had a lower infection rate had either been vaccinated against childhood diseases or had recently received a flu vaccine.
The amount of risk reduction would vary based on which vaccines they had received and how recently they occurred. From the research, it appeared that those who had been vaccinated as children had a lower rate of infection from the coronavirus than those who had received a flu vaccine more recently.
Researchers went to great lengths to account for any variables between the patients, such as age, ethnicity and geographical location. Some critics suggest that the efforts weren’t strong enough. According to the researchers for this study, they are testing the belief that the memory of the immune system is stimulated by a vaccine.
One significant finding in the study was that black patients who had been given the pneumonia vaccine five years earlier had a dramatically lower risk of a positive COVID-19 test than those who hadn’t gotten the vaccine.
Some scientists admit there is plenty of evidence that vaccines can have a positive impact on illnesses beyond what they were designed for. However, they are hesitant to support the findings of the study. They do admit this is a place to begin conducting further research to determine if a current vaccine could be the answer to the coronavirus.
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