Improving Drug Trials: Lessons Learned From AripiprazoleImproving Drug Trials: Lessons Learned From Aripiprazole
Dr Lieberman discusses the FDA's recent warning about the side effects of aripiprazole, what we can learn from this, and how we can better manage a new drug's uncertain potential in the future. Medscape Psychiatry (Source: Medscape Psychiatry Headlines)
Source: Medscape Psychiatry Headlines - May 27, 2016 Category: Psychiatry Tags: Psychiatry Commentary Source Type: news
Otsuka gets in on ReCor Medical’s Paradise renal denervation device
ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension.
Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea and elsewhere in Asia. For starters, Otsuka will test Paradise in Japan to see if it can help patients with treatment-resistant hypertension. Paradise uses ultrasound energy to ablate nerve endings ...
Source: Mass Device - May 16, 2016 Category: Medical Equipment Authors: Mark Hollmer Tags: Clinical Trials Drug-Device Combinations Funding Roundup Pharmaceuticals Otsuka Pharmaceutical ReCor Medical Source Type: news
La FDA advierte de nuevos problemas de control de impulsos en relación con el medicamento para tratar la salud mental aripiprazol (Abilify, Abilify Maintena, Aristada)
[05/03/2016] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que se ha informado de deseos compulsivos o incontrolables de apostar, atracarse de comida, comprar y tener relaciones sexuales con el uso del fármaco antipsicótico aripiprazol (Abilify, Abilify Maintena, Aristada y sus versiones genéricas). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 9, 2016 Category: Drugs & Pharmacology Source Type: news
FDA Warns of Impulse-control Problems With Mental Health Drug
Compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - May 4, 2016 Category: Pharmaceuticals Source Type: news
FDA Warns of Rare Reactions to Abilify Medication
The Food and Drug Administration warned of rare cases in which patients taking the antipsychotic medication Abilify have experienced uncontrollable urges to gamble, binge eat, shop and engage in sex. (Source: WSJ.com: Health)
Source: WSJ.com: Health - May 4, 2016 Category: Pharmaceuticals Tags: FREE Source Type: news
FDA Warns of Compulsive Behaviors Associated with Antipsychotic Aripiprazole (FREE)
By Kelly Young
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The antipsychotic drug aripiprazole (marketed as Abilify, Abilify Maintena, and Aristada) is associated with compulsive or uncontrollable urges to gamble, … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - May 3, 2016 Category: Primary Care Source Type: news
Aripiprazole linked to rare but serious compulsion problems
Rare but serious instances of impulse control problems have been reported in people taking the antipsychotic drug aripiprazole, according to a May 3 press release from the Food and Drug... (Source: Family Practice News)
Source: Family Practice News - May 3, 2016 Category: Primary Care Source Type: news
FDA Warning: Abilify Tied to Impulse Control Problems
(MedPage Today) -- In rare cases, may prompt "uncontrollable urges" (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - May 3, 2016 Category: Psychiatry Source Type: news
Impulse Control Problems Linked to Antipsychotic, FDA WarnsImpulse Control Problems Linked to Antipsychotic, FDA Warns
The FDA is warning of impulse control problems associated with the atypical antipsychotic aripiprazole. News Alerts (Source: Medscape Psychiatry Headlines)
Source: Medscape Psychiatry Headlines - May 3, 2016 Category: Psychiatry Tags: Psychiatry News Alert Source Type: news
FDA Drug Safety Communication: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
[05-03-2016] The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 3, 2016 Category: Drugs & Pharmacology Source Type: news
MassDevice.com +5 | The top 5 medtech stories for April 27, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. FDA wants more from Proteus, Otsuka on ‘smart pill’
Otsuka Pharmaceutical and Proteus Digital Health said today that the FDA issued a complete response letter requesting more information from the companies for the combinat...
Source: Mass Device - April 27, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
FDA declines to approve Proteus-Otsuka sensor-equipped pill, asks for more tests
The FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health's ingestible sensor. The drug, a collaboration between Proteus and Otsuka Pharmaceuticals, combines the Proteus system with the antipsychotic pharmaceutical Abilify. (Source: mobihealthnews)
Source: mobihealthnews - April 27, 2016 Category: Information Technology Source Type: news
FDA wants more from Proteus, Otsuka on ‘smart pill’
Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA issued a complete response letter requesting more information from the companies for the combination of the Proteus “smart pill” and Otsuka’s Abilify anti-depressant drug.
The Proteus pill is designed to signal a wearable patch after it reaches the stomach, recording and time-stamping data from the pill and other patient metrics. The data can be relayed via Bluetooth to mobile devices and, with consent, to healthcare providers.
The federal watchdog is requesting new data from the companies, including information on the per...
Source: Mass Device - April 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Drug-Device Combinations Food & Drug Administration (FDA) Otsuka Pharmaceutical Proteus Digital Health Source Type: news
Drug and behavioural therapy are both effective for tics in people with Tourette syndrome
There are effective drug and behavioural treatments for tics in children and young people with Tourette syndrome. Although most of the studies included in this review were small with risk of , the effects found were moderate to large and likely to be clinically meaningful.
This NIHR funded and qualitative study found that habit reversal therapy, where people with Tourette's are taught to replace their tic with a less noticeable alternative, was effective. The drugs with the best balance of benefits and harms – risperidone, clonidine and aripiprazole – are those most commonly used in the UK. (Source: Current Awareness ...
Source: Current Awareness Service for Health (CASH) - April 7, 2016 Category: Consumer Health News Source Type: news
Facts You Should Know When Taking Abilify for...
Read about the use of Abilify for bipolar disorder and other health conditions, as well as information on its side effects and two black box warnings. (Source: About.com Bipolar Disorder)
Source: About.com Bipolar Disorder - March 28, 2016 Category: Psychiatry Authors: bipolar.guide at about.com Tags: health Source Type: news
