What are the Requirements for a Prescription Drug Label?

What we commonly call a “package insert” is regularly referred to by the FDA as a prescription drug label. Usually consisting of several pages of small print, it is a document which in most cases the patient never sees. Rather, it is more specifically intended for the healthcare professional on the premise that this information will be passed along to the patient. It is a lot of information and seldom does the patient get all or most of it.

In general, the FDA requirements of a prescription drug label are that it be 1) a summary for the safe and effective use of the drug, 2) informative and accurate, 3) not promotional or misleading, 4) without any implied claims or suggestions unless evidence shows it is safe and effective for such purposes; and, 5) based whenever possible on data derived from human experience.

In January 2006, the FDA issued a new rule requiring that the package insert contain a concise, one-half page summary of the information that is more fully explained in the complete document. In many cases, this includes a “boxed warning” concerning serious or life-threatening consequences that may result from use of the drug. Other required information in this section are dosage and administration instructions, contraindications, warnings and precautions, common adverse reactions, drug interactions, use of the drug in specific populations, and a patient counseling information statement.

The patient counseling information is important because it is written for healthcare professionals to remind them about what information is important to convey to the patient.

If you are being prescribed a new medication, or have questions about any of the medications you are on, you should remember to ask any questions that you have. This can be especially important if you are pregnant and have any concerns about whether it is safe for your baby as well as for yourself.

Sadly, and even today, there is no information in the Zofran drug label that warns of possible birth defects. So even if you asked your doctor or nurse this question, there would be nothing in that label to alert you to this serious risk.


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