Posts Tagged ‘FDA’

FDA Approves Resmetirom: First Ever for MASH with Fibrosis

March 16, 2024 — Firsts are worth celebrating. In this case, the cause for celebration is especially great. MASH or metabolic steatohepatitis is a disease that is growing dramatically more common and more harmful to the health of the population. Late this week, FDA approved resmetirom to be the first ever treatment for MASH with fibrosis. Note that the […]

Indication for Heart Health Marks a New Era in Obesity Treatment

March 9, 2024 — It’s official. FDA now says that semaglutide, in doses used to treat obesity, can prevent heart attacks, strokes, and deaths in persons with cardiovascular disease and overweight or obesity. This is nothing short of the dawn of a new era in obesity treatment. FDA Division Director John Sharretts said it clearly: “This patient population has […]

Yogurt Gets an Ad Claim for Preventing Diabetes

March 3, 2024 — Five years ago, Danone asked FDA if it would be OK to say eating yogurt might prevent type 2 diabetes. Or to be precise, “eating yogurt regularly may reduce the risk of type 2 diabetes.” Friday, FDA told Danone, yep, we’re cool with that. Or, in the language of the agency: “FDA concludes that the […]

No, Chocolate Is Not Really Medicine

February 14, 2024 — It seems obvious. If food is medicine, shouldn’t we be confident that chocolate is medicine? Certainly, Uma Naidoo is happy to sell you on this idea. She is a nutritional psychiatrist and author of “This Is Your Brain on Food: An Indispensable Guide to the Surprising Foods That Fight Depression, Anxiety, PTSD, OCD, ADHD and […]

More Calls for People with Obesity in Drug Trials and Labels

January 26, 2024 — The calls are growing louder and more frequent to include people living with obesity in clinical trials and drug labels. Of course trials and labels for drugs that treat obesity include these patients. But the huge problem is that for everything else, more often than not, drug studies and labels exclude them. Now, the American […]

Buyer Beware: Compounded and Fake Semaglutide

January 9, 2024 — Unfortunately, we are facing the new year with a great demand for advanced new obesity medicines and an inadequate supply. On the FDA drug shortages website, all strengths of the Wegovy brand, except 2.4 mg, have limited availability. Both Wegovy and Ozempic are “currently in shortage.” This opens the door for compounded semaglutide and a […]

What Happens When Pharma Can’t Supply? Chaos

December 30, 2023 — FDA tells us we have a problem – actually two of them, and they’re connected to a third. First, counterfeit versions of the Ozempic brand of semaglutide injections are finding their way into pharmacies. These fakes present an inherent risk of problems with safety and effectiveness. Second, compounded versions of semaglutide are selling in some […]

Fix the Blind Spot in Drug Trials Says Every Major Obesity Group

November 29, 2023 — It is time to translate words into action and fix the blind spot in drug trials and labeling for people with obesity. Every major obesity group in the U.S. issued this united call to action on Tuesday. This includes the ASMBS, Obesity Action Coalition, Obesity Medicine, Obesity Society, and STOP Obesity Alliance. It comes as […]

Inflated Claims and Inadequate Testing for Rexulti

November 20, 2023 — FDA has a bone to pick with Otsuka, the company that sells Rexulti (brexpiprazole). The agency is taking issue with false advertising by the company for this drug used in schizophrenia and severe depression. To us, this problem of inflated efficacy claims is especially noteworthy because, for people with obesity who may need this drug, […]

Do Cancer Drugs Work Safely for People with Obesity? Maybe

November 18, 2023 — At a time when nearly half of the U.S. population is living with obesity, this should be an easy question to answer. Obesity clearly causes some forms of cancer and as the prevalence of obesity is rising, patterns of cancer prevalence are shifting, too. So, yes, we should be able to say with great confidence […]