Birth Defects and Topamax,The Mother of All Side Effects

[Guest guest]

http://www.counterpunch.org/rosenberg03212011.html

March 21, 2011

Birth Defects and Topamax

The Mother of All Side Effects

By

MARTHA ROSENBERG

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seen with withdrawn drugs has lacked the side effect that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.

& '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@...

[Guest guest]

http://www.counterpunch.org/rosenberg03212011.html

March 21, 2011

Birth Defects and Topamax

The Mother of All Side Effects

By

MARTHA ROSENBERG

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.

& '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@...

[Guest guest]

http://www.counterpunch.org/rosenberg03212011.html

March 21, 2011

Birth Defects and Topamax

The Mother of All Side Effects

By

MARTHA ROSENBERG

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.

& '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@...

[Guest guest]

http://www.counterpunch.org/rosenberg03212011.html

March 21, 2011

Birth Defects and Topamax

The Mother of All Side Effects

By

MARTHA ROSENBERG

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.

& '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@...