FDA Updates Ozempic Label Warnings; Advisory Panel Votes Against ALS Drug
The label for diabetes treatment Ozempic, popularized by its use as a weight loss drug, will now list blocked intestines as a potential side effect. Two other similar drugs, Wegovy and Mounjaro, already do. In other FDA news, its panel of independent advisers voted 17-1 against recommending a new ALS therapy.
CBS News:
FDA Updates Ozempic Label With Potential Blocked Intestines Side Effect, Also Reported With Wegovy And Mounjaro
The label for the diabetes drug Ozempic — which has become popular for weight loss — now acknowledges reports of blocked intestines following use of the medication. The change comes after the Food and Drug Administration greenlighted a series of updates from drugmaker Novo Nordisk for its product. Ozempic now joins other products in this booming class of so-called GLP-1 agonist medications which acknowledge increased reports of what doctors call ileus, or a blockage in the intestines. (Tin, 9/27)
CNN:
FDA Updates Ozempic Label To Acknowledge Some Users’ Reports Of Blocked Intestines
The US Food and Drug Administration has updated the label of the diabetes drug Ozempic to acknowledge reports of blocked intestines in some people using the medication. (Dillinger, 9/27)
Meanwhile the FDA took action on another drug, this time against ALS —
Stat:
FDA Advisers Vote Against ALS Treatment From BrainStorm
A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval. (Garde, 9/27)
Reuters:
US FDA Panel Votes Against BrainStorm's ALS Therapy Over Effectiveness Concern
Advisers to the U.S. health regulator on Wednesday voted against BrainStorm Cell Therapeutics' (BCLI.O) therapy for a rare and fatal neurodegenerative disease called amyotrophic lateral sclerosis (ALS), marking the newest hurdle in a lengthy regulatory review. While 17 panel members voted that the data presented does not demonstrate substantial evidence of the effectiveness of NurOwn for the treatment of mild-to-moderate ALS, one voted in favor and one member abstained. (Sunny, 9/28)
In other Biden administration news —
Politico:
Boehringer Ingelheim To Opt Into Medicare Price Talks
Boehringer Ingelheim said Wednesday it will enter Medicare price negotiations for its diabetes drug Jardiance, potentially avoiding a hefty tax on sales. Jardiance is one of 10 drugs selected late last month by CMS for price negotiations created under the Inflation Reduction Act. The agency gave manufacturers of the drugs until Oct. 1 to decide whether to enter what is expected to be lengthy talks over a price to be implemented in 2026. (King, 9/27)
Politico:
Biden Declares Emergency For Mississippi River Saltwater Influx
The White House has issued an emergency declaration in response to a massive influx of salt water in Louisiana that has threatened drinking water supplies. In an announcement Wednesday, President Joe Biden said he would approve a disaster declaration in response to a plea from Gov. John Bel Edwards (D). The move will direct federal assistance toward state and local response efforts as Louisiana grapples with a spiraling crisis. (Crunden, 9/27)
Reuters:
US Judge Blocks FTC Bid To Review Louisiana Hospital Deal
A U.S. judge on Wednesday said a hospital consolidation in Louisiana was beyond the reach of federal antitrust law, delivering a setback to the U.S. Federal Trade Commission in a clash over the scope of its power to review certain acquisitions. U.S. District Judge Lance Africk in New Orleans in a 29-page order said Louisiana's consideration and approval of the hospital transaction made it exempt from federal antitrust law. In the deal, nonprofit Louisiana Children's Medical Center acquired three hospitals from HCA Healthcare (HCA.N). (Scarcella, 9/28)
The New York Times:
Peace Corps Sued Over Mental Health Policy
Searching online, Ms. Iodice discovered that her experience was not uncommon. For years, comparing notes under anonymous screen names, Peace Corps applicants have shared stories about being disqualified because of mental health history, including common disorders like depression and anxiety. The practice is the subject of a lawsuit filed this week in federal court, accusing the Peace Corps of discriminating against applicants with disabilities in violation of the Rehabilitation Act, which prohibits discrimination in programs receiving federal funds. (Barry, 9/27)
Also —
KFF Health News:
Readers Rail At Social Security Overpayments And Insurers' Prior Authorizations
KFF Health News gives readers a chance to comment on a recent batch of stories. (9/28)
