March 22nd, 2011

Popular Drug Has Unacceptable Side Effects

The Epoch Times

Americans are getting used to the withdrawal or severe restriction of drugs previously thought to be 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.

The parade of heart, liver, and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators, and drug-makers: birth defects.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

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