What does the evidence actually tell me?
Ask what a drug listing or problem report can actually tell you.
A government drug listing does not mean the medicine is approved. A report of illness does not prove a drug caused it. This page explains what those sources can tell you and what still needs checking.
Does a government drug listing mean approval?
Food and Drug Administration is FDA’s full name; it is the federal agency for medicines.
National Drug Code is shortened to NDC. This number identifies a drug within a government list.
A drug’s NDC number or place on a government list does not mean FDA has approved it.
Request the finished medicine’s approval record. Match the name and form to the proposed treatment. Ask the person prescribing to explain what the record covers.
What can a problem report tell me?
An adverse event is an unwanted experience reported while someone is using a medical product.
FDA says a report alone neither proves a drug caused the problem nor shows how often it happens.
Ask whether the source is describing reports, a study or an approval review. Ask about the exact product studied. If the source does not answer a question, ask the person treating you. A missing answer is not a reason to feel sure the medicine is safe.
Does a committee meeting change what a pharmacy can make?
An advisory panel is a committee that gives an agency advice. It does not make the final decision.
A committee’s vote does not by itself allow a pharmacy to use an ingredient. FDA must formally change the rule before adding it to the list of allowed ingredients.
To change the rule, FDA first proposes the change and invites the public to comment. A proposal is not the final rule.
Ask for the final rule or current approval record when a headline claims that access has changed. Keep proposals, advice and final decisions separate.