Though the antipsychotic Saphris (asenapine) has a Phen-fen type toxicity that has a cumulative effect, especially after using for a year according to the 1000 page document given to the FDA for review, the drug is pending trial in children 12-17 years old for pediatric bipolar.
THE FDA document
"Death from asenapine(Saphris) can come suddenly and without warning in otherwise young healthy individuals due to arrhythmias or strokes." -page 895/1067, June 18, 2008
PDF of 1067 pages, briefing book for the July 2009 FDA Psychopharmacologic Drugs Advisory Committee(meeting materials) at the FDA website, Saphris the atypical antipsychotic-- sublingual immediate release--under the tongue pill.
Zyprexa was used in one trial vs. Saphris, yet there was no placebo control in the 40 week trial for bipolar mania(page 403). Proposed regimens 5-10 mg SZ, BP1 10 mg., no water/food for 10 minutes after taking.(page 479)Page 895/1067
document dated 6-18-2008
"Death from asenapine(Saphris) can come suddenly and without warning in otherwise young healthy individuals due to arrhythmias or strokes with symptoms easily misattributed to something else such as orthostatic hypotension.
More likely most serious cardiovascular toxicities are cumulative resulting in a Phen-fen type toxicity especially when dosed for over a year, although symptoms which are likely to be misattributed to something else, (e.g. fatigue) may occur as soon as the first dose."
page 896/1067 document dated 6-18-2008
----
Pending study
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 AM1)
This study is not yet open for participant recruitment.
Verified on June 2011 by Schering-Plough
First Received on November 18, 2010. Last Updated on June 9, 2011 History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT01244815
Purpose
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 12 and 17 years old, who are either hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial, patients eligible for participation will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. Trial medication and placebo are provided as identical-looking sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting benzodiazepines and psychostimulants approved for the treatment of attention deficit hyperactivity disorder (ADHD). Main treatment effect is measured using the Young Mania Rating Scale (Y-MRS) and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Patients who complete the double blind trial may be offered to continue (open-label) treatment with asenapine for an extended period of time. Follow-up information on safety parameters will be collected in all patients within 30 days following treatment discontinuation.
Official Title: Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated With Bipolar I Disorder (Protocol No. P06107)
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
Responsible Party: Merck Sharp & Dohme Corp ( Vice President, Late Stage Development Group Leader )
ClinicalTrials.gov Identifier: NCT01244815 History of Changes
Other Study ID Numbers: P06107
Study First Received: November 18, 2010
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration
---
Why did the FDA not heed the warnings in the 1000 page brief and why on earth with that side effect profile would the FDA remotely consider allowing this antipsychotic for use in children?
WHAT HAPPENS WHEN A CHILD DROPS DEAD OF CARDIAC ARREST ON SAPHRIS?
Subscribe to:
Post Comments (Atom)
Posts
0 comments:
Post a Comment