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 and over time. Full story.
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 professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated. Full story.
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.
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 of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.
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 each survey, they aim to identify how you use these compounded products in your practice setting. This information will be used by the FDA to inform its development of the 503B Bulks List.
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.
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 systematic reviews on the use of cannabinoids for chronic pain have yielded conflicting conclusions regarding their effectiveness and safety.
“The lack of high quality, evidence-based clinical research into the use of cannabinoids for chronic pain, leaves both clinicians and patients at a distinct disadvantage when weighing the risks and benefits of considering cannabinoids as a pain treatment,” says AAPM Scientific Review and Guidelines Committee Co-Chair, Michael D. Osborne, MD.
On May 30 the AAPM Board of Directors approved an updated position statement on research into the use of cannabinoids for medical purposes, urging FDA to reschedule cannabinoids from Schedule I to Schedule II in order to facilitate needed research into the medical effectiveness, substance toxicity, and overall safety of these products for the treatment of pain. Read the full position statement.
“AAPM promotes individualized, patient-centered pain care delivered by a multidisciplinary team and employing the wide variety of therapies available to improve patient function and reduce suffering. In order for cannabinoids to become a trusted part of the pain management tool kit, it is essential to conduct further research,” says AAPM Scientific Review and Guidelines Committee Co-Chair, Randall Brewer, MD. “We believe that rescheduling tetrahydrocannabinol, an active ingredient in marijuana, will be a critical step in facilitating the necessary research to determine the role of cannabinoids in the treatment of chronic pain.”
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 setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics.
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. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.