Published April 29, 2024
Every time you fill your prescription at the pharmacy you should receive written information about the medicine you are taking. This information is called Consumer Medication Information (CMI) and is written by drug information companies and provided by the pharmacies that use their services. Pharmacies sometimes modify this information to make it shorter and easier to read. The Food and Drug Administration (FDA) does not currently approve or review CMI. Pharmacies typically provide CMI with every prescription that they fill.
There are however, some medicines that have mandatory paperwork that must be given to the consumer. If the FDA determines that a particular medicine or class of medicine is associated with certain risks, a Medication Guide for that drug is required. Medication Guides are paper handouts that are developed by the manufacturer and approved by the FDA. These higher risk medications that are required to have a Medication Guide must be accompanied by the guide every time the medicine is dispensed to the patient. The FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines one (or more) below:
Unfortunately, these important Medication Guides do not always get distributed and even when they do, may be missed or accidentally thrown away by the patient.
It is important to be aware if one of the medicines you are taking has a Medication Guide because the FDA has determined that the drug is linked to a particular risk. In addition, some medicines that have Medication Guides also have an even higher level of risk associated with them. These medicines require special warnings to alert the consumer that very serious or life threatening risks have been associated with that medicine. The warnings are outlined in a black box on the Medication Guide and are appropriately titled a “box warning.” The FDA's database of Medication Guides here.
