The Mother of All Side Effects

Americans are getting used to the withdrawal or severe restriction of drugs “previously thought safe.” From last year’s Avandia warnings to the withdrawal of Vioxx, Bextra, Baycol, Meridia, Trovan and Fen Phen, “Pill Buyer Beware” seems to be a shrewd stance, especially when a drug is new.

Still, the parade of heart, liver and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators and drug-makers: birth defects.

But this month FDA issued a warning that pregnant women who take the antiepileptic drug Topamax are twenty times as likely to have their babies develop cleft lip and cleft palate as they would otherwise be, says Reuters. Children are three times as likely to develop the facial anomalies as infants exposed to other seizure drugs, adds the Associated Press.

Johnson & Johnson’s Topamax is FDA-approved to treat seizures and migraine headache. But like the off-label marketed seizure drugs Neurontin and Lyrica (for which Pfizer paid massive fines), J & J agreed to a $6.1 million fine for illegally marketing Topamax for psychiatric conditions, less than a year ago.

And the marketing worked. Thanks to J & J’s subsidiary Ortho-McNeil’s “Doctor-for-a-Day” scheme in which it paid outside physicians to call on health care providers along with sales reps and speak at meetings and dinners, according to the AP, Topamax made J & J a cool $2 billion a year by 2006. (A lot less than the $6.1 million it paid in criminal fines for the marketing that made the $2 billion.)

Thanks to wide marketing, Topamax has become such a catch-all drug in the military for general pain conditions and other unapproved uses (often in untested psychoactive drug “cocktails” which are now under investigation) it’s called “Stupamax” because of its brain-fogging properties says Army Times.

Nor is this month’s alert the first safety warning for Topamax.

As early as 2004, FDA warned J & J its sales pieces downplayed the “serious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis,” a violation of the Federal Food, Drug and Cosmetic Act. “These materials raise serious public health concerns because they encourage the unsafe use of Topamax, including, particularly, in pediatric patients,” said FDA.

In 2006, FDA warned that Topamax can cause a serious eye condition “characterized by acute myopia and secondary angle closure glaucoma.” The eye side effects can lead to “permanent loss of vision,” if medical care is not sought, says the prescribing information.

In 2008, FDA warned that patients on all antiepileptic drugs should be “monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” and warnings on drug labels were soon required.

And last year FDA refused to approved a diet drug candidate, Qnexa, which includes Topamax along with phentermine, the “good” drug in the Fen Phen combo, because of surfacing Topamax doubts.

Qnexa probably would have worked as a diet drug. People who have used Topamax on the drug rating site askapatient say it does decrease appetite. But the action stems from Topamax making food and drinks taste terrible write more than 33 people. Others say in addition to making you lose weight, Topamax makes you lose your memory, word recall and even hair. Line forms to the left.

Of course widely promoted drugs which turn out to be dangerous after millions use them is nothing new. Many are calling for an end to the pharma Wild West in which even after fines for illegal drug marketing and personal injury settlements, pharma still profits and no principals go to jail.

Especially after Topamax’s new side effects.

MARTHA ROSENBERG can be reached at: martharosenberg@sbcglobal.net


More articles by:

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

March 19, 2018
Henry Heller
The Moment of Trump
John Davis
Pristine Buildings, Tarnished Architect
Uri Avnery
The Fake Enemy
Patrick Cockburn
The Fall of Afrin and the Next Phase of the Syrian War
Nick Pemberton
The Democrats Can’t Save Us
Nomi Prins 
Jared Kushner, RIP: a Political Obituary for the President’s Son-in-Law
Georgina Downs
The Double Standards and Hypocrisy of the UK Government Over the ‘Nerve Agent’ Spy Poisoning
Dean Baker
Trump and the Federal Reserve
Colin Todhunter
The Strategy of Tension Towards Russia and the Push to Nuclear War
Kevin Zeese - Margaret Flowers
US Empire on Decline
Ralph Nader
Ahoy America, Give Trump a Taste of His Own Medicine Starting on Trump Imitation Day
Robert Dodge
Eliminate Nuclear Weapons by Divesting from Them
Laura Finley
Shame on You, Katy Perry
Weekend Edition
March 16, 2018
Friday - Sunday
Michael Uhl
The Tip of the Iceberg: My Lai Fifty Years On
Bruce E. Levine
School Shootings: Who to Listen to Instead of Mainstream Shrinks
Mel Goodman
Caveat Emptor: MSNBC and CNN Use CIA Apologists for False Commentary
Paul Street
The Obama Presidency Gets Some Early High Historiography
Kathy Deacon
Me, My Parents and Red Scares Long Gone
Jeffrey St. Clair
Roaming Charges: Rexless Abandon
Andrew Levine
Good Enemies Are Hard To Find: Therefore Worry
Jim Kavanagh
What to Expect From a Trump / Kim Summit
Ron Jacobs
Trump and His Tariffs
Joshua Frank
Drenched in Crude: It’s an Oil Free For All, But That’s Not a New Thing
Gary Leupp
What If There Was No Collusion?
Matthew Stevenson
Why Vietnam Still Matters: Bernard Fall Dies on the Street Without Joy
Robert Fantina
Bad to Worse: Tillerson, Pompeo and Haspel
Brian Cloughley
Be Prepared, Iran, Because They Want to Destroy You
Richard Moser
What is Organizing?
Scott McLarty
Working Americans Need Independent Politics
Rohullah Naderi
American Gun Violence From an Afghan Perspective
Sharmini Peries - Michael Hudson
Why Trump’s Tariff Travesty Will Not Re-Industrialize the US
Ted Rall
Democrats Should Run on Impeachment
Robert Fisk
Will We Ever See Al Jazeera’s Investigation Into the Israel Lobby?
Kristine Mattis
Superunknown: Scientific Integrity Within the Academic and Media Industrial Complexes
John W. Whitehead
Say No to “Hardening” the Schools with Zero Tolerance Policies and Gun-Toting Cops
Edward Hunt
UN: US Attack On Syrian Civilians Violated International Law
Barbara Nimri Aziz
Iraq Outside History
Wilfred Burchett
Vietnam Will Win: The Long Hard Road
Victor Grossman
Germany: New Faces, Old Policies
Medea Benjamin - Nicolas J. S. Davies
The Iraq Death Toll 15 Years After the US Invasion
Binoy Kampmark
Amazon’s Initiative: Digital Assistants, Home Surveillance and Data
Chuck Collins
Business Leaders Agree: Inequality Hurts The Bottom Line
Jill Richardson
What We Talk About When We Talk About “Free Trade”
Eric Lerner – Jay Arena
A Spark to a Wider Fire: Movement Against Immigrant Detention in New Jersey
Negin Owliaei
Teachers Deserve a Raise: Here’s How to Fund It