Uridine blocks cell damage and cell death caused by fluorouracil chemotherapy, according to the statement.
Uridine was evaluated in two studies of 135 adults and children with cancer treated for a fluorouracil or capecitabine overdose or for early-onset severe or life-threatening toxicities within 96 hours after receiving fluorouracil. Among those treated for an overdose, 97% were alive 30 days after treatment, and among those treated for early-onset severe or life-threatening toxicity, 89% were alive 30 days after treatment. In addition, 33% of the patients resumed chemotherapy within 30 days, according to the FDA statement. Diarrhea, vomiting, and nausea were the most common adverse events associated with treatment.
FDA Advisory Committees Support Changing Codeine Contraindications for Children
BY DEEPAK CHITNIS
AT AN FDA ADVISORY COMMITTEE MEETING
SILVER SPRING, MD—Food and Drug Administration advisory committees have voted overwhelmingly to support expanding the current contraindication for codeine to preclude its use for any pain management in all children under age 18 years.
Twenty members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted on December 10 for the contraindication. Six members elected to contraindicate for any pain management in children younger than 12 years old, and another two members voted only to contraindicate for children younger than age 6 years. One committee member voted not to make any changes to the current contraindications for codeine.
The joint advisory panel also voted to contraindicate the use of codeine for the treatment of cough in all children younger than age 18 years by a similarly robust margin: 20 members voted for contraindicating in all pediatric patients, five voted to contraindicate only in patients younger than age 12 years, one voted to contraindicate in children younger than age 6 years, and three members voted not to make any changes at all.
The final voting question, asking whether to remove codeine from the FDA monograph for over-the-counter use in treating cough in children, was almost unanimously supported by the voting members of both committees. One member supported removing codeine from the monograph only for children under age 2 years.
The decision to vote on approving amendments to the contraindications for codeine use—which would affect not just the monogram, but labeling as well—comes on the heels of the FDA announcing last summer that they would be investigating the safety of codeine-containing drugs in children.
The joint advisory panel cited reports of respiratory depression and death in pediatric patients, variability of codeine metabolism based upon CYP2D6 activity, and the fact that “some regulatory agencies have restricted use of codeine for both cough and analgesia in pediatric patients” as their key reasons for considering the changes to current contraindications, according to Dr Sally Seymour, the FDA’s Deputy Director for Safety.
The FDA is not required to follow the advice of its advisory panels. No members of the panel reported any relevant financial conflicts of interest.
80% of Emergency Physicians Say Mental Health Crisis Response Needs Overhaul
BY WHITNEY MCKNIGHT
Frontline Medical News
Vitals Key clinical point: A new model of psychiatric ED care is being developed by the Coalition on Psychiatric Emergencies (COPE), to improve care, outcomes, and net costs. Major finding: 8 in 10 emergency physicians (EPs) believe a lack of training and resources keep them from meeting a growing demand for emergency mental health services. Data source: American College of Emergency Physicians (ACEP) survey of 1,500 EPs nationwide. Disclosures: COPE is underwritten in part by Teva Pharmaceuticals. |
Emergency medicine professionals have teamed up with mental health workers and patient advocates to call for a new model of care for ED patients in mental health crisis.
The Coalition on Psychiatric Emergencies,” is focused on improving the delivery of emergency psychiatric care, and is supported by more than 30 national emergency medicine, mental health, and patient advocate groups, including the ACEP, the American Psychiatric Association, and the National Alliance on Mental Illness (NAMI). The action comes on the heels of a survey that found 80% of 1,500 US EPs think the system for treating people in acute mental health crisis is broken.
“It’s time we think about doing things differently,” Dr Michael Gerardi, COPE Steering Committee Chair and immediate past president of ACEP, said in a statement. “Through this unique collaboration, the Coalition on Psychiatric Emergencies will focus on developing a more unified treatment model and improving the treatment experience for both patients and health care providers. We want to provide the best care for all our patients and reduce health care costs.”
Among its several goals, the coalition seeks to shorten the time between when a person in mental health crisis presents to the ED and is admitted to an inpatient psychiatric bed. In a recent NAMI survey of 1,400 families, 38% waited more than 7 hours in the ED before seeing a mental health professional. For 21% of those families, the wait was more than 10 hours.