The FDA has asked manufacturers to remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that currently include such language. The affected products are Saxenda (liraglutide), Wegovy...
The FDA is taking steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies — including Hims & Hers and other compounding pharmacies — as similar alternatives to FDA-approved...
The White House issued an Executive Order that orders the Attorney General to take all necessary steps to complete the rulemaking process related to rescheduling marijuana to Schedule III of the Controlled Substances Act in the most expeditious manner in...
The Journal of the American Medical Association (JAMA) recently published a new investigation that explored if semaglutide and tirzepatide – GLP-1 drugs popular for the treatment of diabetes and obesity – reduce the risk of hospitalization for heart failure or...
California Assembly Bill 1103 was signed into law, which will allow the Research Advisory Panel of California (RAPC) to review research projects to be conducted in this state that require the administration of Schedule I or Schedule II controlled substances. Furthermore,...
The FDA announced plans to expedite the development of biosimilar medications to introduce more, lower cost drugs to the market and help treat serious and chronic disease. In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies...
The White House announced an agreement with pharmaceutical manufacturers to increase access to GLP-1 antagonist medications for the treatment of obesity and diabetes. Qualifying Medicare and Medicaid patients can receive certain GLP-1 drugs at a significant discount. Furthermore, individuals who...
A randomized, controlled Phase 3 clinical trial compared VER-01, an experimental cannabis-derived drug, with opioids in 384 patients with chronic low-back pain. VER-01 was found to be superior to opioids in terms of pain reduction over 6 months of treatment....
Regional Anesthesia & Pain Medicine published a retrospective cohort study that examined a national database of patient records from 2004-2024, assessing 10-year outcomes across 26,416 adults who were prescribed gabapentin for low back pain to see what percentage developed dementia...
The FDA is requiring warning label changes to all glucagon-like peptide 1 (GLP-1) receptor agonist medications – a class of drugs used for the treatment of diabetes and obesity – regarding the risk of serious kidney injury that can result...
The FDA is recommending a rescheduling of certain 7-hydroxymitragynine (7-OH) kratom products under the Controlled Substances Act (CSA). Consumer kratom product that can be purchased in cafes, gas stations and online. The FDA’s new recommendation is specifically targeting 7-OH, a...
The FDA announced that all opioid pain medications must update their safety labeling information to better emphasize the risks associated with long-term use. These changes are intended to help health care professionals and patients better understand the benefit-risk profile of...
Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches due to the potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. There is a possibility...
Endo, Inc. announced a voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Various Clonazepam products with the lot number 550176501 may contain the incorrect strength and National Drug Code (NDC) code, thought...
The FDA has determined that the shortage of tirzepatide injections (a GLP-1 antagonist) has been resolved, meaning compounders can no longer create their own formulations of this drug. The FDA is reminding compounders of legal restrictions on making copies of...
