Advocates Want More Warnings From FDA On Diabetes Drug Linked To Fatal Reactions
Because the drug can cause a potentially fatal condition called ketoacidosis in diabetic patients, advocates are calling on the FDA to issue a "black box" warning--the most severe that the agency can slap on a product. In other pharmaceutical news: fatty liver disease treatments, a biotechnology startup, and supplements.
FDA Urged To Heighten Safety Warnings On Common Type 2 Diabetes Drugs
A consumer advocacy is urging the Food and Drug Administration to heighten warnings about a widely prescribed group of diabetes drugs known as SGLT-2 inhibitors, due to hundreds of cases of a potentially fatal reaction among people with type 1 diabetes, even though the medicines are not approved for those patients. In a citizen’s petition being filed with the agency on Wednesday, Public Citizen argued that a “black box” warning, the most serious safety warning found in prescription drug labeling, should note SGLT-2 inhibitors can cause ketocacidosis. (Silverman, 6/24)
Fate Of Intercept's NASH Drug Clouded By Murky FDA Review Delays
On Friday, the Food and Drug Administration is supposed to announce its decision on whether or not to approve the first treatment for the fatty liver disease known as NASH. But that plan has apparently been postponed for reasons that are still not clear. The FDA hasn’t offered an explanation, nor has Intercept Pharmaceuticals, the maker of the NASH drug under review. (Feuerstein, 6/23)
Sana Biotechnology, A Secretive Startup, Lays (Some) Cards On The Table
After years of rumors, Sana Biotechnology is officially biotech’s newest unicorn. The company announced Tuesday that it has raised $700 million — one of the largest initial financing rounds for a biotech startup ever. The cash itself is not new — the money was actually raised in 2018 — but Tuesday’s announcement is the first time the company has disclosed any details about its financial position. (Sheridan, 6/23)
Should You Take A Dietary Supplement To Prevent Disease?
If you've been more concerned about your health lately, you might be wondering if taking a nutrition supplement containing vitamins, minerals or a combination is worthwhile. It's estimated that more than half of Americans take one or more dietary supplements daily or on occasion... But are you wasting your money on vitamins and minerals you don't need or possibly harming yourself by taking high doses? (Drayer, 6/24)