Side Effects At the top of a medication guide
, you will typically see a section entitled, "What is the most important information I should know about (name of drug)" or similar.
The multi-panel wallet style card also includes a medication guide
in a pocket, and the corresponding prescribing insert is adhered to the back of the folded package.
As part of the plan, the FDA wants companies to give patients education materials, including a medication guide
that uses consumer friendly language to explain safe use and disposal.
Three main components make up REMS: a medication guide
(patient package insert), a communication plan for healthcare providers, and elements to assure safe use (EASU).
The approved REMS includes a medication guide
, a communications plan and a timetable for submission of assessments.
The manufacturer also gave the product a standardized drug label and a medication guide
The REMS will cover a Medication Guide
and periodic assessments including a survey of patients' understanding of the potential risks related to the drug.
19, saying it needed more information from J&J about how to minimize potential side effects, including a medication guide
FDA is also requiring the drug's manufacturer to submit a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide
for patients and a timetable for assessment of the REMS.
Drug manufacturers will add a "black box" warning to the prescribing information and develop a medication guide
Manufacturers of all marketed prescription NSMDs must revise labeling to include a boxed warning highlighting an increased risk of cardiovascular events and gastrointestinal bleeding, and distribute a medication guide
with the drugs.