Two FDA panels were almost unanimous in their opinion that the agency should eliminate restrictions that psychiatrists and patients say limit access to clozapine.
Two US Food and Drug Administration advisory panels are urging the agency to eliminate the risk management program for the antipsychotic drugMembers of the Drug Safety and Risk Management and Psychopharmacologic Drugs advisory committees held a joint meeting Tuesday to address whether frequently revised restrictions that have been in place since clozapine was introduced in 1989 should be changed again.
At the meeting, FDA officials said that 148,000 outpatient clozapine prescriptions were written in 2023. But an estimated 814,000 to 1.2 million Americans have treatment-resistant schizophrenia, the main indication for clozapine. Panelists Jess Fiedorowicz, MD, PhD, professor and senior research chair in adult psychiatry at the University of Ottawa, Canada; Megan J. Ehret, PharmD, MS, a panelist and professor at the University of Maryland School of Pharmacy, Baltimore; and Rajesh Narendran, MD, a professor in radiology and psychiatry at the University of Pittsburgh School of Medicine, agreed.
“We estimate about 42,000 patients are not participating in the REMS, said James Shamp, VP of data intelligence and program analytics at United BioSource, a company that supports drug makers. Patients and families also described being rejected at pharmacies — most of which, despite the FDA’s supposed “enforcement discretion” continue to rigorously follow REMS requirements.
U.S. Food And Drug Administration United States Food And Drug Administration Fda Antipsychotics Neuroleptics Neuroleptic Drugs Blood Risk Management Neutropenia Prisons Jail Sentenced Arizona Canada Canadian Drug/Treatment Safety Drug Safety Treatment Safety Exercise Physical Activity Florida Geriatrics Elder Care Geriatric Medicine Older Adults Seniors
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
New York Red Bulls eliminate reigning champions Columbus Crew in first roundThe No. 7 New York Red Bulls eliminated No. 2 Columbus Crew in the first round Sunday, meaning a new MLS Cup champion will be crowned later on.
Read more »
New Jersey suburb poised to eliminate alcohol sale prohibition after 120 yearsVoters in one New Jersey town will decide whether or not they will allow restaurants to sell alcohol, but due to state law only a couple would be allowed.
Read more »
Ahead of Election, Right-Wing Extremist Leonard Leo Seeks to Further Eliminate U.S. Abortion AccessMore Than A Magazine, A Movement
Read more »
Homeowner’s guide to 2024 ballot measures — including one state that could eliminate property taxesToday's Video Headlines: 11/4/24
Read more »
Groups providing rides to early voting sites to help eliminate barriersSome Hoosiers have to overcome a lack of access to transportation to make their voices heard. On the east side, groups are working to bus voters to and from early voting sites.
Read more »
Daylight Saving Time Could End for 10 Million AmericansMichigan lawmakers are considering a new bill to eliminate daylight saving time in the state.
Read more »