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.

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