The parade of heart, liver, and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators, and drug-makers: birth defects.
This month the FDA issued a warning that pregnant women who take the antiepileptic drug Topamax are 20 times as likely to have their babies develop cleft lip and cleft palate, 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 headaches. But like the off-label marketed seizure drugs Neurontin and Lyrica (for which Pfizer paid massive fines), less than a year ago, J & J agreed to a $6.1 million fine for illegally marketing Topamax for psychiatric conditions.
And the marketing worked. Thanks to J & J’s subsidiary Ortho-McNeil’s “Doctor-for-a-Day” scheme, which paid outside physicians to call on health care providers along with sales reps to 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 catchall drug in the military for general pain conditions and other unapproved uses (often in untested psychoactive drug “cocktails” that are now under investigation) it is 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.
Last year the FDA refused to approve 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.com 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. The 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 is a journalist who lives in Chicago.