Medication Updates
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General:

FDA Medication Updates
Medication news, updates and drug safety information on non-controlled substances.
DEA 2010 Pharmacist’s Manual
Guide to Federal Controlled Substances Act and its implementing regulations as they pertain to the pharmacy profession.
NIMH Mental Health Medications Guide
Types of meds used to treat mental disorders, side effects, directions for taking, and FDA warnings.

2013

   
Zolpidem
The FDA has approved label changes specifying new dosing recommendations for zolpidem products
(05/13)
Zolpidem
SAMHSA DAWN Report: Increase in Emergency Department visits for adverse reactions involving the insomnia medication Zolpidem (05/13)
OxyContin
FDA approves abuse-deterrent labeling for reformulated OxyContin.
Agency will not approve generics to original OxyContin (04/13)
     
Antipsychotics in Adults
Clinician summary on antipsychotics for schizophrenia and bipolar disorder (04/13)
Zolpidem Containing Products
FDA requires lower recommended doses - including Ambien, Ambian CR, Edluar, and Zolpimist (01/13)
 
 

2012

   
Budeprion XL
Budeprion XL 300 mg not therapeutically equivalent to Wellbutrin XL 300 mg (10/12)
Atypical Antipsychotics
AHRQ Research summary based on a systematic review for off-label indications in adults. (08/12)
Buprenorphine
ONCP rule amends federal opioid treatment program regulations. More flexibility in dispensing take-home supplies of buprenorphine. (12/12)
     
Escitalopram / Lexapro
First generic Lexapro approved to treat depression and anxiety disorder. (03/12)
Opioids: Drug Information Update
FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. (07/12)
Oxycodone: Drug Information Update
FDA prompts companies to remove certain unapproved oxycodone products from market (07/12)
     
Second-Generation Antidepressants for Treating Adult Depression
AHRQ update to report examining the comparative effectiveness, benefits, and adverse effects of second-generation antidepressants for adults with depression. (07/12)
   
   

2011

Abilify (aripiprazole)
Abilify®  full prescribing information updated - 1.2 Bipolar I Disorder, 2.2 Bipolar I Disorder, 2.6 Dosage Adjustment, 6.2 Clinical Studies Experience, 12.3 Pharmacokinetics, 14.2 Bipolar Disorder (02/11)
Abstral - Opioid Analgesic
FDA approves opioid analgesic Abstral (fentanyl) transmucosal tablets to help cancer patients manage pain. (01/11)
Acetaminophen in prescription medications
FDA limits acetaminophen in prescription combination products to no more than 325 milligrams in each tablet or capsule; requires liver toxicity warnings. (01/11)
(pdf)
     
Antipsychotic drug labels
Labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns. (02/11)
Birth control pills containing Drospirenone
FDA final report of  study that evaluated the risk of blood clots in users of several different hormonal birth control products. (10/11)
Celexa (citalopram hydrobromide)
Celexa should not be used at doses greater than 40 mg/day because it can cause abnormal heart rhythms.
(pdf)
     
Chantix/Varenicline
Healthcare professionals and patients should continue to follow recommendations in physician label and patient Medication Guide, and monitor for neuropsychiatric symptoms when prescribing or using Chantix. (10/11)
Intermezzo (zolpidem tartrate sublingual tablets)
First insomnia drug approved for middle-of-the-night waking followed by difficulty returning to sleep. (11/11)
Methylene Blue
Serious CNS reactions possible when given to patients taking
serotonergic psychiatric medications. (10/11)
FDA Podcast
FDA Podcast
     
Olanzapine/Zyprexa
First generic olanzapine approved to treat schizophrenia, bipolar disorder. (10/11)
Orencia®
Prescribing information updated: Warnings and Precautions - 5.3 Infections, Adverse Reactions - 6.4 Post-Marketing Experience (09/11)
Paliperidone
Medscape: FDA approves Paliperidone (Invega) for treatment of Schizophrenia in adolescents. (04/11)
(pdf)
(Medscape Article - free log in required)
     
Saphris (asenapine maleate)
FDA warning that serious allergic reactions have been reported with use of antipsychotic medication Saphris and it should not be used in patients with known hypersensitivity to the drug. (09/11)
SSRI Antidepressants & Pregnancy
12/14/11 FDA has concluded that it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN.
Stimulant Medications used for ADHD
The FDA is currently reviewing preliminary results of studies sponsored by FDA and AHRQ to research potential cardiovascular risks associated with medications used to treat ADHD in children and adults. (04/11)
     
Stimulant Use for ADHD
NIMH: Prescribed use of stimulant medications to treat ADHD rose slowly but steadily from 1996 to 2008, according to study conducted by NIH and AHRQ. (09/11)
Viibryd (vilazodone hydrochloride)
FDA approved Viibryd tablets to treat major depressive disorder in adults. (01/11)
Zyvox (Linezolid)
Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications. Most cases of serotonin syndrome with linezolid occurred in patients taking specific serotonergic psychiatric drugs - an SSRI or SNRI.
FDA Podcast
     


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