NCPA - National Center for Policy Analysis


November 22, 2005

Patients and physicians often do not comply with black box warnings -- the strongest warning that the Food and Drug Administration (FDA) can issue -- on prescription drugs, according to a study published in the journal Pharmacoepidemiology and Drug Safety.

For the study, researchers from Harvard Medical School and several hospitals and health plans examined claims data for almost one million patients enrolled in 10 health plans nationwide. Researchers also examined black box warning compliance for a smaller group of patients who received one of 19 medications.

  • Researchers found that black box warning compliance ranged "from extremely good for certain drugs that can't be taken during pregnancy to poor for others that should be followed with regular diagnostic tests."
  • For example, valproic acid -- a treatment for epileptic seizures, migraines and bipolar disorder -- includes a black-box warning about liver toxicity that recommends physicians conduct liver tests on patients "prior to therapy and at frequent intervals thereafter."
  • Researchers also found that physicians issued 48.6 percent of valproic acid prescriptions without an initial liver test and that physicians did not conduct ongoing tests 29.5 percent of the time.

Anita Wagner, the lead author of the study and an assistant professor at Harvard Medical School, said that pharmacists and regulators "need to find out how we can communicate the content of the warning clearly to clinicians and patients."

Source: Charles Forelle, "Drug-Safety Labels Often Go Unheeded," Wall Street Journal, November 18, 2005.

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