How effective are black box warnings?
Primary Results of the “Little Black Box”
Here’s a new spin on the concept of “thinking outside the box.”
When a prescription drug is judged by the FDA to be dangerous after the drug has already made it past the approval process, it either gets yanked off the market or it gets saddled with a black box warning.
But how effective is that little black box?
That’s the question researchers at Harvard Medical School set out to answer when they examined records for 217,000 prescriptions of “black box” drugs. Here are the three primary results:
- Among drugs that required monitoring of patients, about 12 percent went unmonitored
- Among drugs that required a lab test before the prescriptions could be filled, about half were filled without the “required” tests
- Nine percent of the prescriptions were filled on the SAME DAY as another drug listed as a potential cause of adverse reactions when taken with the black box drug
In other words, the black box system will work beautifully once all doctors and pharmacists are robots programmed to emit a piercing siren when a black box restriction is contradicted.
But there was one relatively positive item in the results. An Ivanhoe Newswire report on the study noted that for drugs restricted during pregnancy, “most doctors” adhered to the black box warning.
“All” would be comforting. “Most”? Not much comfort there.
Sources:
“Docs Ignore Warning Labels” Ivanhoe Newswire, 11/25/05, Ivanhoe.com
