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Friday, October 6, 2006

Off-Label Usage and Side Effects

Interesting post (and accompanying comments) from Judith Warner on NYTimes.com.  (It may require TimesSelect; I can't tell readily if it's noticing my membership or not.)  The basics:

In early 2005, [Lisa] Collins became pregnant and continued taking [Paxil], with her doctor’s approval, for the first nine weeks of her pregnancy. In November of that year, she gave birth to a baby boy with severe heart abnormalities. A few months later – at just around the time that the baby, Chase, had open-heart surgery, followed by a series of debilitating strokes – Collins heard on the TV news that antidepressants like Paxil had been linked to birth defects.

At about the same time, the F.D.A. updated its Web site to include information on studies linking Paxil use in pregnancy to cardiac defects in infants, approved new labeling for the drug to warn of these risks, and had Paxil recategorized as a Class D substance – one that, in studies of pregnant women, has demonstrated a risk to the fetus.

Collins is now in the process of suing Paxil’s manufacturer, GlaxoSmithKline, and the physician who prescribed it to her.

The potential risks and potential liability on GSK's part aren't Warner's focus, though:

She was prescribed Paxil not because she was depressed, not because she was suffering from severe anxiety, but because she seemed to have symptoms of irritable bowel syndrome and claustrophobia.

* * *

The issue that tugs at me is the offhandedness with which serious drugs are prescribed for not-so-serious issues.

http://lawprofessors.typepad.com/tortsprof/2006/10/offlabel_usage_.html

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Comments

What strikes me is the offhandedness with which Judith Warner classifies irritable bowel syndrome as "not-so-serious" but depression and anxiety are. Historically, the latter were not considered serious, but I agree that they are (and always have been). I don't agree that chronic stomach ailments are not. In addition, I've heard gastroenterologists say they prescribe anti-anxiety medications to patients with irritable bowel syndrome because that ailment can be caused by anxiety.

Posted by: Christine Hurt | Oct 6, 2006 10:22:28 AM

That was a powerful post. It is interesting to note that the victims; Ms. Collins, her baby and all the people in their lives, suffer damages that are so blatant in our high tech world of information. I look forward to the outcome.

Posted by: Rosale Lobo | Oct 6, 2006 4:50:23 PM

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