2016 in Review: A Psychopharmacology Update for Clinicians
Last updated: December 16, 2016 at 16:15 pm
- 1 News From the FDA
- 2 New Treatment Guidelines
- 3 Safety communications
- 4 Substance Use Disorders
Author: Flavio Guzman, MD
Dr. Guzman has no conflicts of interest to disclose.
In this article we take a look back at the most clinically relevant news of 2016 in the field of psychopharmacology.
In terms of new drugs, only one new molecular entity of psychiatric interest was approved (Pimavanserin, for Parkinson’s disease psychosis).
We summarize key points of two new guidelines related to the use of antipsychotics: the APA guidelines on the use of antipsychotics in dementia and the BAP guidelines on metabolic side effects of antipsychotics. The BAP guidelines on the management of bipolar disorder are also discussed here.
We also reproduce two important safety communications from the FDA.
News From the FDA
New Drug Approvals of Psychiatric Interest
|Drug (brand name,
|Selective serotonin 5-HT2A inverse agonist for Parkinson’s disease psychosis.|
New Formulations of Psychiatric Interest
|Drug (brand name,
(Adzenys XR-ODT, Neos)
|Orally disintegrating extended-release tablet for ADHD.|
|New injectable formulation for intravenous use.
Indicated as replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible.
|New implant for subdermal administration of buprenorphine for treatment of opioid dependence.|
(Relistor, Valeant )
|New tablet formulation for opioid-induced constipation.|
New Treatment Guidelines
Use of Antipsychotics in Dementia – American Psychiatric Association
Dr. Rajesh Tampi, Professor of Psychiatry at Case Western Reserve University School of Medicine, summarizes in less than 5 minutes the key recommendations from the APA guidelines on the use of antipsychotics for the treatment of agitation or psychosis associated with dementia.
- If the risk and benefit assessment favors antipsychotic use:
- Initiate at a low dose
- Titrate up to the minimum effective dose as tolerated
- Attempt to taper and withdraw within 4 months of treatment initiation
- Haloperidol should not be used as first-line agent in the absence of delirium
- Long-acting injectable antipsychotics should not be used
- Unless indicated for co-ocurring chronic disorders
Bipolar Disorder – British Association for Psychopharmacology
In March 2016, the British Association for Psychopharmacology published new bipolar disorder guidelines.
The complete publication is 59 pages long, so we extracted some key points that you may find useful:
- Lithium remains the most effective treatment preventing relapse and admission to hospital in bipolar I disorder (I).
- Lithium prevents relapse to mania and, less effectively, depression (I). The highest dose that produces minimal adverse reactions and effects should be employed.
- Concentrations below 0.6 mmol/L are potentially too low to be fully effective and adverse reactions and effects become important above 0.8 mmol/L.
- Lithium reduces the risk of suicide (I).
- Valproate as monotherapy has limited trial data, is somewhat less effective than lithium in the prevention of relapse.
- Valproate should not usually be considered for women of child-bearing potential (I).
- Carbamazepine as monotherapy is less effective than lithium, has little if any effect on relapse to depression and is liable to interfere with the metabolism of other drugs (I).
- Lamotrigine is effective against depression in long-term treatment (I) and should be considered where depression is the major burden of the illness (IV).
- Evidence category I:
- Meta-analysis of RCTs, at least one large, good-quality, RCT or replicated, smaller RCTs
- Large representative population samples
- Evidence category II:
- Small, non-replicated RCTs, at least one controlled study without randomization or evidence from at least one other type of quasi-experimental study
- Evidence category III:
- Non-experimental descriptive studies, such as uncontrolled, comparative, correlation and case-control studies
- Non-representative surveys, case reports
- Evidence category IV:
Expert committee reports or opinions and/or clinical experience of BAP expert group
Management of metabolic side effects associated with antipsychotics – British Association for Psychopharmacology
The BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment review trials of interventions for people experiencing weight gain when taking antipsychotics and make recommendations regarding appropriate interventions.
We reproduce selected recommendations for overweight and obesity.
Lifestyle interventions (mostly of the behavioral lifestyle intervention type)
- Lifestyle interventions are recommended as they have a positive effect in the majority of RCTs (A).
- These should almost always be part of the first line of approach and in most circumstances shuold be continued in addition to any additional intervention (S).
- On average, these interventions will reduce existing weight by approximately 3 kg or more, and BMI by approximately 1 kg/m2 more, than the control treatment.
- Switching to one of the antipsychotics with lower propensity for weight gain is a strategy that hsould be considered (B).
- Evidence comes from meta-analyses of the differential effects of different medications on weight:
- Data suggests a hierarchy of antipsychotics with respect to weight gain: haloperidol, ziprasidone, lurasidone, aripiprazole, amisulpride and asenapine appear to carry the lowest propensity.
- Clinicians must balance the possible benefit on weight of switching antipsychotic medication against the risks of inducing relapse of core psychotic symptoms (S).
- Adjunctive aripiprazole is recommended as a possible intervention for weight gain associated with clozapine and olanzapine (B).
- In people taking antipsychotic medications, short-term trials have shown that metformin reduces weight by approximately 3 kg (A).
- Metformin attenuates weight gain in first-episode initiations of antipsychotic medication by approximately 5 kg, compared to placebo (A).
- There are some risks attached to metformin that require appropriate monitoring (renal function and vitamin B12) (S).
Reference – Strength of recommendation
- A – Directly based on category I evidence from meta-analysis of randomised controlled trials, at least one large, good quality, randomised controlled trial or replicated, smaller, randomised controlled trials
- B – Directly based on category II evidence from meta-analysis of randomised controlled trials, at least one large, good quality, randomised controlled trial or replicated, smaller, randomised controlled trials, or extrapolateda recommendation from category I evidence
- C – Directly based on category III evidence from non-experimental descriptive studies, such as uncontrolled, comparative, correlation and case–control studies, or extrapolated recommendation from category I or II evidence
- D – Directly based on category IV evidence from expert committee reports or opinions and/or clinical experience of respected authorities, or extrapolateda recommendation from category I, II or III evidence
- S – Standard of good practice
Other Guidelines of Interest
Below you can find a list of new clinical guidelines published during 2016, all links point to the free full text version.
- Management of adults with major depressive disorder – Canadian Network for Mood and Anxiety Treatments (CANMAT)
- Treatment of adolescent sexual offenders with paraphilic disorders – World Federation of Societies of Biological Psychiatry (WFSBP)
- Guidelines for opioid use – Centers for Disease Control and Prevention
- Suicide and suicide attempts in adolescents – American Academy of Pediatrics
- Management of chronic insomnia disorder in adults – American College of Physicians
Aripiprazole: New FDA Warning on Impulse Control Risks
From FDA’s safety announcement:
“The FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of aripiprazole. These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.
Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. In addition, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine.
As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.”
New Brand Name for Vortioxetine in the US: Trintellix
The FDA approved a brand name change for vortioxetine (Brintelix), the new brand name of the drug is now Trintellix.
This change was implemented to decrease the risk of prescribing and dispensing errors resulting from name confusion with the antiplatelet drug ticagrelor (Brilinta).
Substance Use Disorders
The US American Society of Addiction Medicine has created the map below to detail each state’s law on legalization, medical marijuana and decriminalization.
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