The Food and Drug Administration (FDA) must approve any drug before it can be sold. This is true whether it's a prescription or an over-the-counter drug. Most of us have opened a box of medication and taken out the paper Medication Guide many prescription medicines. Why should you put on your glasses and read them? These guides address issues that are specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events, including:
- information necessary to prevent serious adverse effects
- information about a known serious side effect with a medication
- information about patient adherence to directions for the use of a product are essential to the medications effectiveness
An adverse event is any undesirable experience associated with the use of a medical product in a patient. The FDA requires hospitals, physicians, pharmacists, and even consumers to report adverse events (i.e. deaths, life-threatening events, and hospitalizations suspected as an outcome from a medication use) to the FDA Adverse Event Reporting System (FAERS) database. FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a product, evaluating a manufacturer's compliance to reporting regulations, and responding to outside requests for information.
If a potential safety concern is identified in FAERS, further evaluation is performed. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public’s health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
So read the Medication Guide inside your next medication package. Know what to look out for! When in doubt, talk to your doctor, nurse, or pharmacist. Learn more about reporting adverse events to the FDA.