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).
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.
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 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.
FDA issues strongest warning of risks when combining opioid pain or cough medicines with benzodiazepines
The review found that combined use of these drugs results in serious side effects, including difficulty breathing and death.
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 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 warns of name confusion with Brintellix (vortioxetine) and Brilinta (ticagrelor)
Reports of confusion between Brintellix (an antidepressant) and Brilinta (an anti-blood clotting medication) have resulted in the wrong medication being prescribed or dispensed.
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.