The Package Insert is a series I’ve been publishing since March. Each installment reads the FDA-approved prescribing information for a major drug class and reports what the labels actually say — including what they admit has not been studied.
Two things about this post.
First, the backlog is now free. Every installment published so far — seven in total, covering the drug classes tens of millions of people take every day — is available below to every subscriber, paid or unpaid. New installments will continue to be for paid subscribers. If you know someone on one of these drugs, you now have access to what the label says.
Second, they have been redesigned. The versions below are not the Substack post reformatted as a PDF. They have been properly typeset — a clean cover, generous margins, readable body type, pull quotes for the key findings, “Ask your doctor” callouts drawn directly from what each label admits, and a printable list of questions at the end of every installment. They look, in short, like documents worth printing. Documents worth handing to a family member. Documents your uncle who never opens a Substack link will actually read.
That is the point. These are not opinion pieces. Every claim in every installment comes from the manufacturer’s own prescribing information — the same document filed with the FDA and available on its website. The labels are public. The job of these PDFs is to make them legible to the patient in the chair, and shareable with the family members who won’t otherwise see them.
Seven installments, in the order they were published. Download them. Print them. Send them. That is what they are for.
Statins — Five Labels, One Drug Class
25 March 2026
The five best-selling statins in the United States — Lipitor, Crestor, Zocor, Pravachol, Mevacor — have been prescribed to tens of millions of Americans. Only two of them are FDA-approved to reduce total mortality. Simvastatin produced liver carcinomas in 90% of male mice at high doses. The diabetes warning that now appears on every label in the class was not on the original approvals — it was added decades later. The first installment in the series
ACE Inhibitors — What Five FDA Labels Say About America’s Most Prescribed Blood Pressure Drug Class
29 March 2026
Lisinopril, enalapril, ramipril, benazepril, quinapril. Every label carries a boxed warning about injury and death to the developing fetus. Every label acknowledges the drugs work less effectively in Black patients when used alone — while carrying a higher rate of the potentially fatal angioedema in the same population. One drug in the class, quinapril, has never had its effect on long-term mortality in heart failure evaluated. After four decades on the market, every label still states that whether the mechanism involves bradykinin “remains to be elucidated.”
Finasteride and Dutasteride — The Hair Loss Drugs Whose Sexual Side Effects May Not Stop When the Drug Does
6 April 2026
Propecia and Avodart. Both labels report post-marketing cases of sexual dysfunction that continued after stopping the drug. Both carry warnings about high-grade prostate cancer. Both can feminise the genitalia of a male fetus through skin contact with the pills. Finasteride crosses the blood-brain barrier. Dutasteride remains detectable in the blood for four to six months after the last dose. Prescribed to otherwise healthy men in their twenties and thirties for cosmetic purposes.
Bipolar Medications — What Five Labels Say About the Drugs 6 Million Americans Combine
8 April 2026
Seroquel, Lithobid, Lamictal, Depakote, Abilify. Fifty-seven percent of Seroquel patients experience somnolence in bipolar depression trials. Depakote’s boxed warning includes decreased IQ and neural tube defects in exposed offspring. Abilify’s label documents post-approval reports of pathological gambling, compulsive sexual urges and binge eating. Every one of the five labels admits the drug’s mechanism of action is unknown, unclear or unestablished. And bipolar patients routinely take two or three of these drugs simultaneously — a combination none of the labels was written to describe.
GLP-1 Drugs — Ozempic, Wegovy, Mounjaro, Trulicity, Zepbound
13 April 2026
The class that reshaped medicine in five years. Fifty-one percent of Mounjaro patients developed what the label calls anti-tirzepatide antibodies. Every label in the class carries a boxed warning about thyroid C-cell tumours in rodents. Every label documents fetal harm in three animal species at clinically relevant exposures. The Wegovy fracture signal in women and patients over 75 — visible in the manufacturer’s own cardiovascular outcomes trial — appears in no patient-facing material. The tirzepatide labels tell women on oral contraceptives to switch methods for four weeks after every dose change.
Flu Vaccines — What the Labels Say About the Shots Recommended Every Year
15 April 2026
Nine products — the full US-licensed flu vaccine market for the 2025-26 season. In March 2026, one month before this installment was published, the FDA added a new warning to three of the most-administered labels: febrile seizures in children aged 6 months through 4 years, at a rate the label describes as “suggestive of a causal relationship.” Every label admits the vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. No flu vaccine on the US market this winter has been trial-tested against the strains it actually contains. FluMist sheds live virus from vaccinees for a mean of 7.6 days.
Proton Pump Inhibitors — The Drug You Can’t Stop Taking
10 May 2026
Prilosec, Protonix, Nexium. Approved for four to eight weeks of use. Taken by tens of millions of Americans for years. The labels describe the trap by mechanism: acid suppression of 80 to 94 percent, gastrin rebound, symptoms returning worse than they were. Every warning that matters on these labels was added after the original 1989 approval — bone fracture, hypomagnesaemia, B-12 deficiency, interstitial nephritis, C. difficile diarrhoea. Pantoprazole was carcinogenic in long-term rodent studies. The relevance to humans, the label says, is unknown.
Each document is a printable version of the original article. If you find them useful, share them. That is what they are for.
This work stays free because paid subscribers make it possible. They get the full book library, the Deep Dive Audio Library, and the Questions for Your Doctor, Before You Consent, and Package Insert series. No grants, no gatekeepers — your subscription is what keeps it that way.
I doubt that anyone taking these drugs has any idea what the side effects are. Thanks for doing this. It is so helpful to me whose family are all some sort of medical practitioners and think everything on the market is safe.
Thanks. Look forward to studying them.