Four Common Antipsychotic Drugs Found to Lack Safety and Effectiveness in Older Adults

In older adults, antipsychotic drugs are commonly prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications – schizophrenia and bipolar disorder. The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia, some of which carry FDA warnings on prescription information for these drugs.

In a new study – led by researchers at the University of California, San Diego School of Medicine, Stanford University and the University of Iowa, and funded by the National Institute of Mental Health – four of the antipsychotics most commonly prescribed off label for use in patients over 40 were found to lack both safety and effectiveness. … Read the full story from the UCSD Newsroom

Department of Medicine endocrinology and metabolism researchers Robert R. Henry, MD, and Sunder Mudaliar, MD, are coinvestigators in the study of the antipsychotic drugs.Dr. Robert R. Henry

Robert R. Henry, MD, is professor of medicine in the Division of Endocrinology & Metabolism at UC San Diego. At the Veterans Affairs San Diego Healthcare System (VASDHS), he is Chief of the Section of Endocrinology, Metabolism & Diabetes and Director of the Center for Metabolic Research.

Sunder Mudaliar, MD, is health sciences clinical professor in the Division of Endocrinology & Metabolism at UCSD. He is extensively involved in medical teaching and clinical care at the VASDHS. As an investigator in the Center for Metabolic Research, he performs clinical research focused on the prevention and treatment of diabetes.

More information:

Citation for the study report: Jin H, Shih PB,Golshan S, Mudaliar S, Henry R, Glorioso DK, Arndt S, Kraemer HC, Jeste DV. Comparison of Longer-Term Safety and Effectiveness of 4 Atypical Antipsychotics in Patients Over Age 40: A Trial Using Equipoise-Stratified Randomization. E-pub ahead of print, November 27, 2012, The Journal of Clinical Psychiatry.

Potency of Statins Linked to Muscle Side Effects

A study from the University of California, San Diego School of Medicine, published August 22 online by PLoS ONE, reports that muscle problems reported by patients taking statins were related to the strength or potency of the given cholesterol-lowering drugs. … Read the full story from the UCSD Newsroom

Dr. Beatrice Golomb led the study team. Beatrice Golomb, MD, PhD, is professor of medicine in the Division of General Internal Medicine.More information:

  • Citation for the new study: Hoffman KB, Kraus C, Dimbil M, Golomb BA. A survey of the FDA’s AERS database regarding muscle and tendon adverse events linked to the statin drug class. PLoS One. 2012;7(8):e42866. doi: 10.1371/journal.pone.0042866. Epub 2012 Aug 22. Abstract
  • Related study: Statins Shown to Cause Fatigue

Study Identifies Potential New Class of Drug for Treating Ulcerative Colitis

Oral Drug Shows Clinical Response and Remission in Some Patients

An investigational drug currently under FDA review for the treatment of rheumatoid arthritis has now shown positive results in patients with moderate-to-severe ulcerative colitis, according to researchers at the University of California San Diego, School of Medicine. The study will appear in the August 16, 2012 issue of the New England Journal of Medicine (NEJM). … Read the full story from the UCSD Newsroom

Dr. William J. SandbornThe principal investigator of the study is Dr. William J. Sandborn, professor of medicine and chief of the Division of Gastroenterology at UCSD.  |  Read his academic profile  |  Read his clinical profile

Read the abstract of the study report in the New England Journal of Medicine

Citation of study report:  Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24.

Dr. Januario E. Castro Receives R01 Grant Award for Leukemia Research

Dr. Januario E. CastroJanuario E. Castro, M.D., has received a 3-year R01 grant from the Food and Drug Administration to investigate a new immunogene therapy for chronic lymphocytic leukemia (CLL).

Dr. Castro is Assistant Clinical Professor of Medicine in the Divisions of Hematology-Oncology and Blood & Bone Marrow Transplantation.

Dr. Castro’s project is “Gene therapy of chronic lymphocytic leukemia using intranodal injection of Ad-ISF35.”

Its goal is to evaluate the clinical and pre-clinical activity of Ad-ISF35, a replication-defective adenovirus vector that encodes a chimeric (human-mouse) CD154 molecule. The Ad-ISF35 is employed to transduce cancer cells and induce anti-tumor responses.

Dr. Castro and his coworkers have conducted a promising preliminary Phase 1 clinical study of Ad-ISF35 in six patients. Recently, they reported some of their findings in the Proceedings of the National Academy of Sciences (PNAS).   Read the PNAS article

The R01 funding comes from the FDA’s Office of Orphan Products Development and is expected to start in May or June of this year.

The grant will allow Dr. Castro and his team to continue the Phase 1 trial as well as to begin an extension protocol and continue correlative studies to develop this new therapeutic strategy.

The project’s co-principal investigator is Dr. Castro’s mentor, Thomas Kipps, M.D., Ph.D., Professor of Medicine in the Division of Hematology-Oncology.

More Information