Dear Dr. Roach: Why is it that certain medications warn against possible infections in the perineum? I saw an ad for Jardiance that warned against this. Just now, I viewed a Farxiga ad, and there was the same warning spelled out in the bottom left-hand corner of the screen. This seems very specific. What is it about the perineum that makes it so susceptible, as opposed to other areas on the body?
S.S.
Empagliflozin (Jardiance) and dapagliflozin (Farxiga) are both medicines for diabetes in the SGLT2 inhibitor class. These work by causing the kidneys to release sugar from the blood into the urine. Known side effects are urine and yeast infections.
Fournier’s gangrene is a very rare, soft-tissue infection of the perineum. The “perineum” is broadly considered the area around the genitals in both men and women. In men, the “perineal body” is located between the scrotum and rectum, and in women, it’s between the opening of the vagina and rectum.
Diabetes is a major risk factor for Fournier’s gangrene, but people taking SGLT2 inhibitors seem to get Fournier’s gangrene more than people who take other medications for diabetes. The risk can’t be quantified with accuracy; just over 3 per 100,000 men between the ages of 50-79 will get this condition. Fifty-five cases associated with SGLT2 inhibitors were identified by the Food and Drug Administration in a six-year time period. They were prescribed to 1.7 million people during this time period, so the risk is quite small.
The FDA was concerned enough about a possible increase in this rare but very serious condition that they issue the strongest possible warning. Every ad you see or read in the United States will include a warning about this condition.
Although I don’t recommend stopping these medicines due to concerns about this rare infection, people on these drugs should be aware of warning signs, such as fever, swelling, tenderness, or redness in and around the perineum. You should seek prompt medical attention if they occur.
Dear Dr. Roach: Do Parkinson’s patients go through a form of sundowning, where their behavior changes during the early evening?
S.F.
“Sundowning” refers to the worsening of confusion at nightfall in people with cognitive disorders such as Alzheimer’s disease. However, longstanding Parkinson’s disease can also lead to cognitive problems (dementia). For people who have had Parkinson’s for more than 20 years, the prevalence of dementia is above 80%. Sundowning can be very mild or quite severe, and it can be very distressing to both the patient and their caregivers.
Cognitive impairment in Parkinson’s disease is usually treated the same way it is with Alzheimer’s, with a medication of modest effectiveness, like donepezil (Aricept). Sundowning is more about confusion, or even an impaired sense of what is real or not (“psychosis”). It is usually treated with specific medications, such as quetiapine or pimavanserin. The dosing of these can be timed so that the person experiences very little sundowning. Experienced physicians know that sometimes very little of the medication is enough to help prevent the problem.
Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to [email protected]
