FacebookTwitterGoogle+RedditEmail

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Still, the parade of heart, liver and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators and drug-makers: birth defects.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

August 20, 2018
Carl Boggs
The Road to Disaster?
James Munson
“Not With a Bomb, But a Whimper” … Then More Bombs.
Jonathan Cook
Corbyn’s Labour Party is Being Made to Fail –By Design
Robert Fisk
A US Trade War With Turkey Over a Pastor? Don’t Believe It
Howard Lisnoff
The Mass Media’s Outrage at Trump: Why the Surprise?
Faisal Khan
A British Muslim’s Perspective on the Burkha Debate
Andrew Kahn
Inhumanity Above the Clouds
Dan Glazebrook
Trump’s New Financial War on the Global South
George Wuerthner
Why the Gallatin Range Deserves Protection
Ted Rall
Is Trump a Brand-New Weird Existential Threat? No.
Sheldon Richman
For the Love of Reason
Susie Day
Why Pundits Scare Me
Dean Baker
Does France’s Economy Need to Be Renewed?
Jeffrey St. Clair
A Mighty Voice for Peace Has Gone Silent: Uri Avnery, 1923-2018
Weekend Edition
August 17, 2018
Friday - Sunday
Daniel Wolff
The Aretha Dialogue
Nick Pemberton
Donald Trump and the Rise of Patriotism 
Joseph Natoli
First Amendment Rights and the Court of Popular Opinion
Andrew Levine
Midterms 2018: What’s There to Hope For?
Robert Hunziker
Hothouse Earth
Jeffrey St. Clair
Roaming Charges: Running Out of Fools
Ajamu Baraka
Opposing Bipartisan Warmongering is Defending Human Rights of the Poor and Working Class
Paul Street
Corporate Media: the Enemy of the People
David Macaray
Trump and the Sex Tape
CJ Hopkins
Where Have All the Nazis Gone?
Daniel Falcone
The Future of NATO: an Interview With Richard Falk
Cesar Chelala
The Historic Responsibility of the Catholic Church
Ron Jacobs
The Barbarism of US Immigration Policy
Kenneth Surin
In Shanghai
William Camacaro - Frederick B. Mills
The Military Option Against Venezuela in the “Year of the Americas”
Nancy Kurshan
The Whole World Was Watching: Chicago ’68, Revisited
Robert Fantina
Yemeni and Palestinian Children
Alexandra Isfahani-Hammond
Orcas and Other-Than-Human Grief
Shoshana Fine – Thomas Lindemann
Migrants Deaths: European Democracies and the Right to Not Protect?
Paul Edwards
Totally Irrusianal
Thomas Knapp
Murphy’s Law: Big Tech Must Serve as Censorship Subcontractors
Mark Ashwill
More Demons Unleashed After Fulbright University Vietnam Official Drops Rhetorical Bombshells
Ralph Nader
Going Fundamental Eludes Congressional Progressives
Hans-Armin Ohlmann
My Longest Day: How World War II Ended for My Family
Matthew Funke
The Nordic Countries Aren’t Socialist
Daniel Warner
Tiger Woods, Donald Trump and Crime and Punishment
Dave Lindorff
Mainstream Media Hypocrisy on Display
Jeff Cohen
Democrats Gather in Chicago: Elite Party or Party of the People?
Victor Grossman
Stand Up With New Hope in Germany?
Christopher Brauchli
A Family Affair
Jill Richardson
Profiting From Poison
FacebookTwitterGoogle+RedditEmail