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Category: Med Alert

74 posts found

JAMA Study Notes Possible Cardiovascular Benefits for GLP-1 Antagonists

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...
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California to Expedite Research Around Schedule I & II Drugs

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,...
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FDA Moves to Accelerate Biosimilar Development

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 In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies...
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White House Announces Deal to Expand Access to GLP-1 Medications

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...
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Cannabis Drug Beats Opioid in Phase 3 Low Back Pain Trial

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....
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New Study Links Frequent Gabapentin Use to Higher Risk for Cognitive Impairment

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...
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FDA Requires New Kidney Injury Warning for All GLP-1 Drugs

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...
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FDA Takes Steps to Restrict Certain Kratom Products

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...
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FDA Orders Opioid Manufacturers to Update Prescribing Information for Long-Term Use

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...
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One Lot of Fentanyl Patches Recalled Due to Patches Multi-Stacking

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...
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Lot of Clonazepam Recalled Due to Carton Strength Mislabeling

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...
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FDA Updates Compounding Policy for GLP-1 Medications

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...
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FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test

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...
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FDA Rejects MDMA as PTSD Treatment

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...
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Healthy Living OTC Migraine Drug Recalled Due to Lack of Label

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...
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