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.
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