FDA Approvals of Opioids Based on Insufficient Efficacy and Safety Data
A new cross-sectional study uncovers shortcomings in pivotal trials supporting new drug applications for opioid analgesics, which range from study design to duration. Read more.
FDA Approves XARACOLL® (bupivacaine HCl) Implant, a Non-Opioid, Drug-Device Treatment Option for Acute Postsurgical Pain Relief
XARACOLL is a unique, non-injectable drug-device combination in the form of a fully bioresorbable collagen implant containing bupivacaine hydrochloride. XARACOLL is placed directly into the surgical site during surgery and, after placement, releases bupivacaine immediately [...]
FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing
FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care [...]
FDA Alert: AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products
AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines. Full story.
FDA Warns about Serious Breathing Problems with Seizure and Nerve Pain Medicines Gabapentin
The U.S. Food and Drug Administration is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use [...]
University of Maryland Center of Excellence in Regulatory Science and Innovation Survey Participation Opportunity
The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the FDA, is conducting research to better understand how compounded products are used in clinical practice. Through completion of [...]
FDA MedWatch Safety Alert: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products
RXQ Compounding, LLC ("RXQ") is voluntarily recalling all sterile human and animal products within expiry to the user level due to lack of sterility process assurance associated with the production of the Company's sterile products.Full [...]
AAPM Issues Updated Position Statement on Research into the Use of Cannabinoids for Medical Purposes
More than 30 states as well as Washington D.C. have legalized cannabis for medical purposes, making it more accessible than ever before to patients throughout the country, including patients suffering from chronic pain. However, major [...]
FDA Announces Public Meeting to Discuss Safety and Utility of Higher-Dose Opioid Analgesics
FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient [...]
FDA MedWatch Safety Alert: Ketorolac Tromethamine Injection by Sagent Pharmaceuticals: Recall – Due to Lack of Sterility Assurance
Sagent Pharmaceuticals, announced the voluntary nationwide recall of Lot Number M813513 of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. [...]