August 2018 the Food and Drug Administration alerted diabetic patients of the dangers of the SGLT2 inhibitor medications for a specific type of gangrene. This is not just one drug but a class of medications. The condition, commonly called genital gangrene, is serious and can even be fatal.
This type of drug is used to treat type 2 diabetes, but it has also seen some effectiveness in type 1 diabetes. Type 2 diabetes results in a high blood glucose level because the body cannot use the insulin up. It’s most common in middle-aged adults and seniors, but it can occur in other ages as well. This type of diabetes is known as hyperglycemia and is the most common form.
SGLT2 inhibitors work by moving the excess insulin out of the body through the kidneys and in the urine. They work in conjunction with diet and exercise to help the person be able to regulate their glucose levels.
Medications are used to control the diabetes unless the condition is too severe and requires other treatments. Since diabetes drugs are the most common form of treatment, it’s important for patients to understand the risks.
Gangrene and Diabetes
The type of gangrene the FDA warns of with the SGLT2 inhibitors is called Fournier’s gangrene or genital gangrene and is necrotizing fasciitis. It is a rare form of gangrene that only affects the genital areas of patients, mostly men.
In fact, most of the people diagnosed with this condition have been males between 50 and 70 years of age. It affects 1.6 men out of 100,000 each year, which shows how rare it is even for diabetics. A total of 1.7 million people received prescriptions for SGLT2 inhibitors in 2017.
To develop this condition, bacteria must enter a cut in the body. The bacteria then attack the tissue under the skin around the genital area. It causes an infection in the tissue and swelling or tenderness and redness around the genitals. If left untreated, it can cause a severe infection and loss of tissue as well as death.
The Link Between Genital Gangrene and Diabetes Medications
Studies indicate that taking the SGLT2 inhibitors can increase the risk for developing this condition. Between 2013 and 2018, 12 people were diagnosed with the condition, five of which were women. It’s extremely rare for a woman to develop this type of gangrene and at double the normal rate.
Anyone with diabetes is at a greater risk for developing gangrene than someone who doesn’t have the condition because of limited circulation and reduced blood flow. With the addition of the medication, the risk goes up even more.
The drug increases the amount of glucose in the urine, which helps to feed any infection in the body. It can slow down the healing process even if the cut is small. This allows the bacteria to continue to grow and develop into a serious situation.
Supporters of the medications say that 12 cases indicate a minimal risk for those who rely on the drugs to help them control their glucose levels. However, the FDA now requires manufacturers of these drugs to label them with the new warning. This ensures that they are aware of the risk if they choose to take the medication.
Of those 12 who were diagnosed with Fournier’s gangrene, one person died. Four others suffered various complications from the condition and all needed multiple surgeries to remove the dead tissue.
While genital gangrene is certainly one of the most serious results of taking these SGLT2 inhibitors, it is by no means the only risk. Anytime a medication causes additional glucose to move through the kidneys and urine, it puts the person at risk for other infections, such as urinary tract infections. Because diabetics heal at a slower rate in many cases, they can develop other complications and have a more severe reaction to the symptoms.
Anyone who is taking SGLT2 inhibitors should talk to their doctors about the risks and potential side effects. They not only need to know about genital gangrene but other conditions. They need to ask their doctor what symptoms to look for and what to do if they notice signs of problems.
While these inhibitors have shown some positive results for diabetics who are trying to control their type 2 diabetes, they do not come without some level of risk. Many patients may be able to take the drugs with no concerns, but they need to be aware of those risks and make an informed choice.
Pfizer Vaccine for COVID Shows Positive Trial Results
Scientists working on what is known as BNT162b1 say the new vaccine shows promise for COVID-19. This vaccine is based on RNA gene technology, which has been deemed to be cutting edge.
Researchers claim that it created a strong immune response in those who participated in the study. The response continued to increase with the second dose and the amount given.
The research trail was led by Pfizer Inc. a pharmaceutical company. RNA is a geneticcode that triggers the immune system when it encounters a virus. Strategies for vaccines that utilize RNA are generally considered to be safe, which helps increase the speed of developing a vaccine.
The trial was a small one of only 45 participants. They were all adults who were determined to be healthy. They were between 18 and 55 years of age. Half of them were given a dose of the vaccine at either a low, medium or high dose. The other half were given a placebo.
Those that received the vaccine showed an immune response with a higher response for those who took the larger dose. A second booster continued to improvethe immune system.
It was also noted that participants tolerated the vaccine relatively well. They did notice soreness where the vaccine was injected. Participants reported headache, fatigue, fever and issues with sleeping which all cleared up within a week after being vaccinated.
Scientists look at this study as good news for battling the coronavirus. However, a phase 3 trial will be necessary, which will test the vaccine on a larger population to determine its true effectiveness as well as safety and preferred dosage. The study showed a higher number of antibodies for those participants even than what peoplewho are recovering from the virus have. However, the phase 3 trial will show how effective the vaccine will be in real life when a vaccinated person is in contact with the virus.
Numerous Vaccines in Trials
There are dozens of vaccines in various stages of the trials. Phase 1 and 2 are the early stages with testing on limited participants. Phase 3 is the final stage and features a much larger trial to determine safety. This trial can take several months, and the information must be presented before the US Food and Drug Administration will approve it for use on the general population.
Many drugs make it through the first two trials only to have poor results in phase 3. While this information for the Pfizer vaccine shows promise, the average patient won’t even know if it will be available for the general public for some time. Once it is approved, the manufacturer will have to develop large quantities of the vaccine to
provide to the population. Best estimates are still sometime in 2021 before there is a vaccine available to prevent COVID-19. Until then, other precautions are recommended to reduce the spread and fatalities for the coronavirus. Updates on this and other vaccines will be provided as the research team continues through theprocess.
Metformin as Potential Protector from COVID-19
Metformin is a common medication given to people diagnosed with type 2 diabetes. This group also happens to be considered high-risk for the coronavirus. Studies indicate the medication may help protect the vulnerable diabetics patients from some of the most severe symptoms of COVID-19 and reduce the number of fatalities.
COVID-19 Benefits Possible
A study was conducted by a doctor at the Hugh Kaul Precision Medicine Institute at the University of Alabama at Birmingham. The results have been published online but not reviewed by peers yet.
According to the researchers who reviewed information from over 600 patients, metformin was linked to almost 70 percent reduction in deaths for those who were diagnosed with diabetes and COVID-19. This information coincides with data from four other studies. That data was published in Diabetes and Metabolism.
Researchers suggest that metformin may have anti-inflammatory effects to go along with its ability to lower glucose levels. However, they do advise caution in reading too much into the data unless random controlled trials can be conducted.
According to experts, patients who take metformin tend to have better results in many situations. What hasn’t been determined if the medication can be called a miracle drug or if the people taking it are generally in better health and have no issues with use. They say there isn’t enough data to recommend metformin for use against COVID-19 at this time.
Possible Positive Results for the Study
In the Alabama study, 40 percent of the more than 600 patients were diagnosed with diabetes. Patients with diabetes were accountable for more than 60 percent of the deaths reported in this group. Independent predictors of death for the group included being diabetic, make and between the ages of 50 and 70. A total of 42 patients with diabetes died, and 18 of them had not used metformin. This means that 34 had used the drug, which led to an 11 percent mortality rate for metformin users. This percentage is comparable to the general population rather than the 23 percent rate for diabetics who didn’t take the drug.
Survival rate was determined after removing those with chronic kidney disease, heart failure and other contraindications. Critics of the study suggest that other factors can also impact the change in mortality rate. It can be assumed that control of glucose levels and body weight as well as a reduction in inflammation and other health improvements could also have a positive influence on the survival of the patient with COVID-19.
There are risks for diabetics who take metformin, particularly the increase in risk for lactic acidosis, which can lead to failure of multiple organs. It is unlikely that trials will be conducted to prove the benefits of metformin because pharmaceutical companies aren’t interested in studying a medication that is out of patent and no longer expensive. While these small studies may indicate potential benefits of taking metformin, it is unlikely to be substantiated with larger trials. Patients should only take the medication if it is effective for their condition, according to experts.
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.
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