Medication Updates
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Medication:
FDA releases updated Drug Safety Communication about Opioids
The update reinforces that individuals who are physically dependent on opioids may experience serious harm if their medications are suddenly discontinued or their dose is rapidly decreased.
Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program Modified
The FDA has approved a modification to the REMS program that implements new requirements for prescribers in February 2019.
FDA approves Spravato (esketamine) for treatment-resistant depression
The U.S. Food and Drug Administration approved the nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
Naloxone Hydrochloride Injection by Hospira Recalled
Due to the potential presence of particulate matter, Hospira, Inc is recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection.
FDA warns about immune system reaction with Lamictal (lamotrigine)
This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly.
FDA approves Lucemyra for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
Drug may lessen the severity of withdrawal symptoms, but may not completely prevent them and is only approved for treatment for up to 14 days.
Sublocade approved for treatment of moderate-to-severe opioid use disorder
Sublocade is the first once-monthly injectable buprenorphine product to be FDA approved for adult patients who initiated treatment with a transmucosal buprenorphine product.
FDA Revises Position on Opioid Use Medications and Benzodiazepines
After additional review, the FDA advises that buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other CNS depressants.
Amneal Pharmaceuticals Recalls Lorazepam Oral Concentrate
The voluntary recall affects 13 lots of the USP 2mg/mL concentrate due to a defect in the dropper markings.
FDA requests market removal of oxymorphone hydrochloride for risks related to abuse
The FDA is concerned that Opana ER (oxymorphone hydrochloride), an opioid pain medication, has risks that now outweigh its benefits.
First generic Strattera approved by FDA for ADHD treatment
The FDA has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
FDA approves Ingrezza, the first drug to treat tardive dyskinesia
Ingrezza (valbenazine) treats tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements.
FDA revises risk of mental health side effects of Chantix and Zyban
After a large clinical trial, the revised risk of mental health side effects with Chantix (varenicline) and Zyban (bupropion) was found to be lower than previously thought.
5 new buprenorphine and naloxone medications approved
Bunavail, Suboxone (tablet), Suboxone (film), Subutex, and Zubsolv have been approved.
FDA warns about impulse-control problems associated with aripiprazole (Abilify, Abilify Maintena, Aristada)
FDA reports that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of aripiprazole, an antipsychotic.
FDA approves Aristada (aripiprazole lauroxil) to treat schizophrenia
FDA approved Aristada extended release injection to treat adults with schizophrenia.
FDA approves Vraylar (cariprazine) to treat schizophrenia and bipolar disorder
Vraylar capsules approved to treat schizophrenia and bipolar disorder in adults.
FDA modifies monitoring for neutropenia in patients using clozapine; approves new REMS program
The FDA is changing the requirements for clozapine to address safety concerns about neutropenia, a serious blood condition. The FDA also approves new shared REMS program to improve monitoring and treatment of patients with severe neutropenia.
FDA approves first drug treatment for sexual desire disorder
The FDA has approved Addyi (flibanserin) to treat acquired, generalized hypoactive sectual desire disorder (HSDD) in premenopausal women.
FDA warns of counterfeiting issue with Diazepam purchased online
Diazepam purchased on the internet runs the potential risk of being counterfeit, the FDA reports. 700 adverse reactions have been reported in patients taking mislabeled Diazepam.
LFDA reports permanent skin-color changes with use of Daytrana patch (methylphenidate transdermal system)
The FDA is warning that use of the Daytrana patch (methylphenidate transdermal system) for ADHD may lead to permanent loss of skin color.
First Generic Abilify (aripiprazole) approved by FDA
Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.
New Guidance on Medication-Assisted Treatment for Alcohol Use Disorder
SAMHSA guide for expanding use of medication in clinical practice for the treatment of alcohol use disorder.
FDA expands uses of Vyvanse to treat binge-eating disorder
Vynase (lisdexamfetamine dimesylate) is now approved to treat binge-eating disorder in adults.
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Tags: Medication Updates, PMHN Resources |
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