The Package Insert Series
Every prescription drug sold in the United States comes with an FDA-approved package insert — a document of 20 to 35 pages, written by the manufacturer, reviewed by the regulator, and filed with the agency. It tells you what the drug does, what it doesn’t do, what it might do to you, and what no one has bothered to find out. Most patients have never seen it. Most doctors don’t walk through it. But it exists, it’s publicly available, and it says what it says. Among the things it says: drugs that raise blood sugar past the diabetes threshold, trigger angioedema in the airway, produce tumors in animal studies, and carry boxed warnings about fetal injury. These are not allegations from the margins. They are statements from the labels themselves.
The Package Insert is a series that reads these documents — the ones your prescriber should have walked through with you. Each installment takes a major drug class, reads the FDA-approved labels for the top-selling products in that class front to back, and reports what they actually say. The series ends each piece with a printable list of questions drawn directly from what the labels admit, what they leave unstudied, and what they bury in small type. Nothing here is medical advice. The purpose is to help you read what’s already written about the drugs you’re taking, and to ask better questions of the people prescribing them.
Available to paid subscribers.
ACE Inhibitors — What Five FDA Labels Say About America’s Most Prescribed Blood Pressure Drug Class
Bipolar Medications — What Five Labels Say About the Drugs 6 Million Americans Combine
Flu Vaccines — What the Labels Say About the Shots Recommended Every Year