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.
Xanax Recall for Presence of Foreign Substance
Mylan Pharmaceuticals Inc., the manufacturer of Xanax, an anti-anxiety medication, is recalling one of the lots due to the possible presence of a foreign substance. However, the company said it is unlikely that someone would be ill because of the substance in the medication.
The recall affects just one lot of the medication in bottles. These bottles contain 500 tablets of 0.5 milligrams of Alprazolam, the generic form of Xanax. No adverse effects have been reported at this time, but the company admitted there is a remote chance of infection.
Mylan didn’t comment on what the foreign substance is, but voluntarily issued the recall notice. Bottles with the lot number 8082708 are part of the recall. They have an expiration date of September 2020 smf and were sold in July and August. Anyone with this medication can return the product. They can call (888) 843-0255 or email firstname.lastname@example.org.
What is Xanax?
Xanax is a prescription medication given by doctors to treat anxiety or panic disorders. It impacts chemicals in the brain that may be out of balance. It is listed in a class of medications known as benzodiazepines, which provide a calming affect for people. Xanax is popular because it works quickly to calm the person.
When a person’s brain doesn’t manufacturer enough GABA, a natural chemical designed to produce a calming effect during times of high stress of anxiety, they may need help in the form of Xanax.
Common side effects from this medication include:
- Feeling tired or drowsy
- Lack of balance or being uncoordinated
- Slurred speech
- Problems remembering things
- Feeling anxious first thing in the morning
Other drugs may impact Xanax, including prescription and over-the-counter medications as well as herbs and vitamins. Some side effects may be quite serious, such as mood changes, hallucinations and thoughts of suicide. These symptoms should be taken seriously and medical attention gotten right away.
A doctor will generally start a patient out on the lowest dosage of Xanax, increasing the dose until it works well in treating the anxiety. It’s important to not stop taking the drug abruptly because it can cause seizures. A doctor will generally taper off the dose over time. There is a risk for addiction with Xanax, especially for those who take the drug for a long time.
Xanax is a popular street drug because of its addictive properties. Many people sell their prescriptions while others seek out the medication when their doctor won’t prescribe it for them anymore. When taken at higher doses, it can provide a euphoric effect that lasts for several hours.
A person shouldn’t drink alcohol or use marijuana when taking Xanax because it can increase the potency of the other substances. Anyone who has a history of lung or breathing conditions should let their doctor know before taking the medication.
Anyone who is currently taking Xanax should check their bottle to ensure it isn’t part of the recall. If they notice any unusual symptoms, they should talk to their doctor.
Anticoagulants Could Cause Serious Conditions When Taken with Other Medications
A recent study showed that about one-third of the people who are taking anticoagulants weren’t aware of the risk for serious interactions when the medication is mixed with over-the-counter drugs. The risks include internal bleeding, which could be dangerous.
According to research, almost all of the people who were on a prescription anticoagulant took some OTC medications or supplements at the same time. Of those, about one-third were taking a product that could cause internal bleeding when taken with the anticoagulant. Patients weren’t aware of the potential interactions or their severity.
What are Anticoagulants?
This type of medication is often used to treat patients who have a higher risk for stroke and are diagnosed with atrial fibrillation. The patients are most often older. The drug most often prescribed is Apixaban. The patients don’t usually have monthly follow-ups or aren’t seen in anticoagulation clinics, so they may not be educated in the possibility of drug interactions.
Medications like Apixaban are used to prevent blood clots for patients with atrial fibrillation. They may also be given after knee or hip replacement surgery to reduce the risk of blood clots. Because it impacts the body’s ability to clot, it can lead to serious bleeding. A person needs medical attention right away if they start noticing changes in vision, confusion, weakness on one side or if their speech becomes slurred. These could be indications of internal bleeding. Other indications include:
- Unusual bruising
- Cuts that bleed longer than normal
- Pain or swelling
- Coughing up blood
- Frequent nosebleeds
- Blood in vomit or stool
- Persistent tiredness
- Difficulty swallowing
The study had researchers interviewing patients from April 2018 to October 2018 who had been taking apixaban. They asked about their knowledge of any possible interactions with the drug and other OTC products. They asked how often they took these other medications which included the following:
- Fish oils
- Herbal teas
- Chinese herbs
The results of the study showed that more education is needed on the risk of bleeding and other dangers to combining anticoagulants and OTC products. The study was limited because of a low response rate, a limited number of products included in the study and the self-reporting of the patients.
Warnings for the Medication
Precautions for the drug list bleeding as a possible side effect. Drinking alcohol daily can increase the risk for stomach bleeding. It also lists other safety measures a person can take, including using a safety razor for shaving and a soft toothbrush. If a person falls and hits their head, they should seek medical care to check for hidden bleeding.
Patients should also tell their doctor if they have a history of stroke, blood disorders, kidney disease or if they suffer from frequent falls.
According to the study, even though these precautions are given, many people are still not aware of the dangers of mixing the medication with other products. Since internal bleeding may not be obvious, it can become a dangerous condition for the patient.
Number of Opioid Prescriptions in New Jersey Drops with New State Law
New Jersey saw a 22 percent decrease in opioid prescriptions given out after a new law went into effect. The law limits prescriptions of opioids such as oxycodone to a five-day supply on new orders. An alert notifies those filling the prescriptions if the limit has been reached.
Prescriptions Decline in New Jersey
The study is the first of its kind in reviewing the impact of such a state law and the effects of an electronic medical record on reporting. According to the study, no evidence has been found to suggest that pain control declined.
The study monitored phone calls and hospital visits to determine if the reduction in pain medication had an impact on pain or recovery. None were found from the research done after the law went into effect. The law was passed in May 2017 for any patients who had not been on opioid medications for more than a year. In total, 33 states have implemented some types of limits or restrictions for new prescriptions. Pennsylvania has a seven-day limit for specific situations.
Medicare and some private insurance providers have also implemented limits, which doctors must be aware of when prescribing these medications. These requirements are in addition to any state laws.
A Study of the Impact of Alerts and Legislation on Opioid Use
The study required two years of research before and after the new law went into effect. In New Jersey, during the time of the study, 668 new prescriptions were written and 4368 in Pennsylvania. These scripts included the best-known opioids, such as hydrocodone, oxycodone, morphine, codeine, tramadol, and hydromorphone.
The average dosage before the law went into effect as 225 MME in New Jersey and 150 MME in Pennsylvania. Generally, 30 tablets were prescribed. After the law passed, the MME went down from 225 to 150 and the number of tablets decreased from 30 to 20. No change was noted in Pennsylvania, which is interesting since it didn’t have an electronic medical record system to provide alerts. The decrease in number of prescriptions went down 22 percent in New Jersey compared to eight percent in Pennsylvania.
What the results of the study show is that the law may not have as much effect as the electronic alerts. Targeted interventions may be the best tools to see change with opioid prescriptions. The goal with these resources is to provide flexibility to doctors while encouraging them to make prescriptions safer for the patient.
Opioid prescriptions may lead to dependency when given over the long-term. They can also lead to illicit drug abuse when the person is no longer able to obtain the prescription drug. With the rise in opioid overdoses and the indication that many of the situations began with prescriptions, public concern has led to new rules and regulations to limit the opioid drugs getting into the hands of patients while still providing the quality of care necessary to treat acute and chronic pain and other medical conditions. In time, the information may show which tools are providing the best results.
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