Side Effects

A recent New York times piece by Gina Kolata summarizes some recent writing in medical journals bemoaning the proliferation of side effects in drug labels.

From the FDA:

"extensive lists of rare and minor adverse events for which there are no data to support a causal relationship" are not useful.

I don't know exactly what the FDA is means by "data to support a causal relationship", but considering that it takes millions of dollars of randomized experimentation to get evidence of a causal relationship that the drug works, it's going to be slightly expensive to provide any comparable level of evidence about side effects.

Patients weighed in as well:

Jim Murrell, a 54-year-old telecommunications consultant who lives in the Atlanta suburbs, says he wants to know all about adverse drug reactions but he has decided the labels are not helpful; he looks for better sources on the Internet.

"I took a medication that had the side effect of drowsiness," he said. "I read a little further and saw it had another side effect. Insomnia. One medication had diarrhea as a side effect and it also had constipation."

"It makes no sense," Mr. Murrell said.

Of course it's entirely possible for a medication to cause both insomnia and drowsiness because the drug may interact with patient characteristics to produce different side effects. But wow, it's going to be pretty tough to provide any warning about interactive side effects without lowering our standards of evidence because of the sheer proliferation of possible effects.

Posted by Richard Nielsen at June 8, 2011 1:26 AM