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...
The FDA granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results...
The FDA declined to approve a new drug application for MDMA as a treatment for PTSD. The FDA cited insufficient data, requesting additional clinical trial data to assess safe and effective use. The initial application presented positive data from two...
One lot of Healthy Living Migraine Relief (acetaminophen, aspirin and caffeine) tablets (Lot No AC2523005A) was recalled due to a missing product label. This product lacks required labeling information, drug facts, and patient usage information. There is significant risk of...
A lot of clonazepam orally disintegrating tablets (Lot No 550147301) has been recalled due to mislabeling with incorrect strength on the carton. Clonazepam can be used to treat seizures, as well as panic and anxiety disorders. The product labeling shows...
One lot of acetaminophen injections 1000mg/100mL, (10mg/mL) was recalled (Lot No24070381), due to the possible presence of a bag labeled dexmedetomidine inside the acetaminophen overwrap. If a provider administers dexmedetomidine instead of acetaminophen, there are multiple potential adverse outcomes that...
The FDA issued an alert to providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products, due to reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with...
Hospira, Inc., a Pfizer company, is voluntarily recalling two lots of Buprenorphine Hydrochloride Injection Carpuject Units due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit. In the event that impacted products...
The FDA received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, compounders and patients about the risk of potentially serious allergic-type reactions to sulfite-containing compounded drugs. Health care professionals and patients may...
