What is a Black Box Warning?
Boxed Warning:
This type of warning is also commonly referred to as a “black box warning.” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.
The FDA (Food and Drug Administration) approves a drug for marketing after determining that the drug’s benefits outweigh the risks for the condition that the drug will treat.
But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population.
Adverse drug reaction:
An adverse drug reaction (ADR), also called a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.
The Black Box Warning is the strongest warning that the FDA requires. This warning is reserved for prescription drugs that pose a significant risk of serious or life-threatening adverse effects, based on medical studies. The Black Box Warning is included in the labeling or medical information of the prescription drug. Search Drug specific index
PGx Medical has implemented the Metabolic Validation Program (Pharmacogenetic Testing) in hundreds of clinics and homes across the country. This program helps reduce the risk of adverse drug reactions, maximize drug efficacy and individualize drug dose.
Pharmacogenetics uses information (such as DNA sequence, gene expression, and copy number) for purposes of explaining inter individual differences in drug metabolism (pharmacokinetics) and physiological drug response (pharmacodynamics), identifying responders and non responders to a drug, and predicting the efficacy and/or toxicity of a drug. Eliminating the “trial & error” process and improving quality of life.
For more information on the PGx Metabolic Validation Program, contact:
PGx Medical
info@pgxmed.com
405-509-5112