FDA Information
Introduction
You can search the FDA (Food and Drug Administration) database for ‘Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).’ A Medication Guide is an FDA-approved handout given with certain prescription medications. It explains important safety risks, helps patients understand serious side effects, and gives direction that may be necessary for the medication to work correctly.
Below are a list of commonly prescribed medications and their respective FDA Medication Guides and/or important FDA announcements.
- Stimulants
- Anti-Depressant
- Citalopram (marketed as Celexa) Information
- Celexa-Abnormal Heart Rhythms 8/24/2011
- Escitalopram (marketed as Lexapro) Information
- Fluoxetine (marketed as Prozac) Information
- Fluvoxamine Maleate Information
- Paroxetine hydrochloride (marketed as Paxil) Information
- Sertraline (marketed as Zoloft) Information
- SSRIs and Potential Risk for Persistent Pulmonary Hypertension of the Newborn
- Anti-Psychotics
- Aripiprazole – Impulse-control problems
- Clonzapine – Modified Monitoring for Neutropenia, New REMS program
- Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication
- Olanzapine -- Rare but Serious Skin Reactions
- Ziprasidone (Geodon) -- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Mood Stabilizers