Click amount to donate direct to CounterPunch
  • $25
  • $50
  • $100
  • $500
  • $other
  • use PayPal
DOUBLE YOUR DONATION!
We don’t run corporate ads. We don’t shake our readers down for money every month or every quarter like some other sites out there. We provide our site for free to all, but the bandwidth we pay to do so doesn’t come cheap. A generous donor is matching all donations of $100 or more! So please donate now to double your punch!
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Still, the parade of heart, liver and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators and drug-makers: birth defects.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).

October 23, 2018
Patrick Cockburn
The Middle East, Not Russia, Will Prove Trump’s Downfall
Ipek S. Burnett
The Assault on The New Colossus: Trump’s Threat to Close the U.S.-Mexican Border
Mary Troy Johnston
The War on Terror is the Reign of Terror
Maximilian Werner
The Rhetoric and Reality of Death by Grizzly
David Macaray
Teamsters, Hells Angels, and Self-Determination
Jeffrey Sommers
“No People, Big Problem”: Democracy and Its Discontents In Latvia
Dean Baker
Looking for the Next Crisis: the Not Very Scary World of CLOs
Binoy Kampmark
Leaking for Change: ASIO, Jakarta, and Australia’s Jerusalem Problem
Chris Wright
The Necessity of “Lesser-Evil” Voting
Muhammad Othman
Daunting Challenge for Activists: The Cook Customer “Connection”
Don Fitz
A Debate for Auditor: What the Papers Wouldn’t Say
October 22, 2018
Henry Giroux
Neoliberalism in the Age of Pedagogical Terrorism
Melvin Goodman
Washington’s Latest Cold War Maneuver: Pulling Out of the INF
David Mattson
Basket of Deplorables Revisited: Grizzly Bears at the Mercy of Wyoming
Michelle Renee Matisons
Hurricane War Zone Further Immiserates Florida Panhandle, Panama City
Tom Gill
A Storm is Brewing in Europe: Italy and Its Public Finances Are at the Center of It
Suyapa Portillo Villeda
An Illegitimate, US-Backed Regime is Fueling the Honduran Refugee Crisis
Christopher Brauchli
The Liars’ Bench
Gary Leupp
Will Trump Split the World by Endorsing a Bold-Faced Lie?
Michael Howard
The New York Times’ Animal Cruelty Fetish
Alice Slater
Time Out for Nukes!
Geoff Dutton
Yes, Virginia, There are Conspiracies—I Think
Daniel Warner
Davos in the Desert: To Attend or Not, That is Not the Question
Priti Gulati Cox – Stan Cox
Mothers of Exiles: For Many, the Child-Separation Ordeal May Never End
Manuel E. Yepe
Pence v. China: Cold War 2.0 May Have Just Begun
Raouf Halaby
Of Pith Helmets and Sartorial Colonialism
Dan Carey
Aspirational Goals  
Wim Laven
Intentional or Incompetence—Voter Suppression Where We Live
Weekend Edition
October 19, 2018
Friday - Sunday
Jason Hirthler
The Pieties of the Liberal Class
Jeffrey St. Clair
A Day in My Life at CounterPunch
Paul Street
“Male Energy,” Authoritarian Whiteness and Creeping Fascism in the Age of Trump
Nick Pemberton
Reflections on Chomsky’s Voting Strategy: Why The Democratic Party Can’t Be Saved
John Davis
The Last History of the United States
Yigal Bronner
The Road to Khan al-Akhmar
Robert Hunziker
The Negan Syndrome
Andrew Levine
Democrats Ahead: Progressives Beware
Rannie Amiri
There is No “Proxy War” in Yemen
David Rosen
America’s Lost Souls: the 21st Century Lumpen-Proletariat?
Joseph Natoli
The Age of Misrepresentations
Ron Jacobs
History Is Not Kind
John Laforge
White House Radiation: Weakened Regulations Would Save Industry Billions
Ramzy Baroud
The UN ‘Sheriff’: Nikki Haley Elevated Israel, Damaged US Standing
Robert Fantina
Trump, Human Rights and the Middle East
Anthony Pahnke – Jim Goodman
NAFTA 2.0 Will Help Corporations More Than Farmers
Jill Richardson
Identity Crisis: Elizabeth Warren’s Claims Cherokee Heritage
FacebookTwitterGoogle+RedditEmail