Novo Nordisk addresses off-label Ozempic use as it grapples with multiple shortages by Nicole DeFeudis for EndPoints.com, 13 December 2022.
On the heels of Wegovy supply troubles, Novo Nordisk is reporting a shortage of its diabetes treatment Ozempic which contains the same active ingredient, semaglutide. The company said that it’s experiencing “intermittent supply disruptions” for the Ozempic pen that delivers 0.25 and 0.5 mg doses of the drug, caused by “incredible demand coupled with overall global supply constraints.” On Dec. 7, the American Society of Health-System Pharmacists reported shortages affecting both the 0.25 mg or 5 mg doses, as well as the 1 mg and 2 mg doses using various pen injectors. “The company is working to resolve the issue by early 2023,” the ASHP report stated.
While Novo Nordisk declined to confirm whether the shortages are due to off-label use of Ozempic as a weight loss treatment, it did acknowledge that some providers may be prescribing the drug for such use. “While we recognize that some healthcare providers may be prescribing Ozempic for patients whose goal is to lose weight, it is up to the clinical discretion of each healthcare provider to choose the best treatment approach for their patients,” the company said in an email.
Read more: Novo Nordisk addresses off-label Ozempic use as it grapples with multiple shortages
Artificially Sweetened Drinks May Up Risk for Urinary Incontinence by Lori Solomon for HealthDay.com, 16 December 2022. Higher risk seen among women drinking one or more beverages per day
Consuming artificially sweetened beverages may increase a woman’s risk for urinary incontinence, according to a study published online 13 December 2022 in Menopause. Nancy E. Ringel, M.D., from the Yale School of Medicine in New Haven, Connecticut, and colleagues used data from 80,388 women participating in the Women’s Health Initiative Observational Study to assess whether higher artificially sweetened beverage intake is associated with a higher prevalence of urinary incontinence symptoms.
The researchers found that the unadjusted odds of reporting urinary incontinence were higher in women consuming one to six servings per week or greater than or equal to one serving per day versus never to less than one serving per week. Compared with women never drinking or drinking less than one serving per week, women consuming one or more servings per day had higher odds of reporting mixed urinary incontinence.
But, another post about the same study: Do Artificially Sweetened Drinks Affect Urinary Incontinence by Dr. Hena Mariam claimed, from the same study, that contrary to popular belief, the consumption of artificially sweetened beverages does not have a significant effect on a woman’s likelihood of developing urinary incontinence. However, an ad on the post pointed to meditation as effective in treating urinary incontinence in women.
Conclusions from the study: When compared to never to less than one serving per week, women consuming greater than or equal to one serving per day of artificially sweetened beverages had 10% greater odds of reporting mixed urinary incontinence after adjustments. The amount of artificially sweetened beverage consumption was not associated with stress or urgent urinary incontinence symptoms.
CDC warns of future surge in diabetes among young Americans by Brad Dress for TheHill.com, 29 December 2023.
The U.S. Centers for Disease Control and Prevention (CDC) on Thursday warned a surge of diabetes among young Americans is on the horizon, saying diagnoses for the population are expected to soar in the coming decades. The CDC cited a new study published in the journal Diabetes Care, which models a nearly 700 percent increase of Type 2 diabetes diagnoses in Americans under the age of 20 through 2060 if an expected upward trend continues.
Type 1 diabetes could also increase 65 percent among young Americans in the next 40 years following the same trend.
Debra Houry, the CDC’s acting principal deputy director, said the “new research should serve as a wake-up call for all of us. It’s vital that we focus our efforts to ensure all Americans, especially our young people, are the healthiest they can be. It was important to prevent and manage chronic diseases, not only for our current population but also for generations to come.
Read more: CDC warns of future surge in diabetes among young Americans
Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine by Jeffrey N. Gibbs & Sara W. Koblitz for TheFDALawBlog.com, 22 December 2022.
In the Appropriations Bill, the proposed provision amends section 516(a) of the FDC Act (21 U.S.C. § 360f(a)) to allow the FDA to ban a device “for one or more intended uses” and states that “A device that is banned for one or more intended uses is not a legally marketed device under section 1006 when intended for such use or uses.” Section 1006 refers to the “Practice of Medicine” provision of the FDC Act (21 U.S.C. § 396), which prohibits the FDA from limiting or interfering “with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease . . . .” In other words, Congress is proposing to let the FDA ban devices for particular uses, including off-label uses.
This provision represents a complete shift in the way FDA is allowed to regulate products. Previously, FDA determined whether a product was safe and effective for its intended use but could not dictate the way a practitioner used that product. That, of course, is reserved for the practice of medicine, and FDA does not govern the practice of medicine. This proposed revision turns that premise on its head: If FDA can say that a given device can’t be used for a specific treatment, then the practice of medicine is inherently subject to FDA discretion, regardless of the provisions in section 1006. Congress has effectively narrowed Section 1006 by giving FDA the authority to ban off-label uses of devices.
Read more: Congress May Let FDA Regulate the Practice of Medicine
Way off-topic but timely! Hey, 2023! Here’s How To Say ‘Happy New Year’ in 45 Different Languages by Vanessa Hall for Parade.com, 1 January 2023. Ring in 2023 by wishing your family and friends ‘Happy New Year!’ in different languages.
It may be true that not all cultures celebrate the new year in the same way, or even at the same time, but it’s a nice gesture to include everyone during the holidays. That’s what the holidays are all about, right? They’re a time to spend with family and friends and to cherish the happy memories we have together while making more.
Wishing friends and family a happy New Year is great, but what if you could kick it up a notch? Try wishing each person you know a Happy New Year in a different language! Or, try to get in as many different languages as you can with everyone you know! No matter how you choose to branch out this holiday, we have compiled a list of how to say “Happy New Year!” in 45 different languages so you can expand your good wishes!
Read more: Hey, 2023! Here’s How To Say ‘Happy New Year’ in 45 Different Languages
And just some giggles!
If congress changes the law to allow FDA to ban device uses, would that mean that any device can be used for any issue not specifically banned? For instance if a syringe is banned for injecting heroin, is it OK to prescribe it to inject cocaine? I think it leaves the docotr potentially off the hook. Yes I suggested they use XYZ with that device, but it was not prohibited by the FDA. I think I like the responsibility being on the doctor not the FDA.
I refuse to tell the lovely Ms. Sheryl about the urinary thing. She has been drinking Diet Coke / Tab for 47 years. I am fearful I will be blamed.