Perspective: Black box drugs raise red flags

By Charles A. Pilcher MD FACEP
August, 2014

“Black Box” drugs: Open the box with care

In the past few years I have been involved with 3 cases related to drugs with a “black box warning.” All 3 involved the accidental arterial injection of a low pH medication that caused severe vasospasm, arterial and arteriolar injury, and disastrous results to various limbs.

Last December, Medical Economics published a nice article by attorney Barbara Knothe on these “black box” drugs. These are drugs that require the strongest available warning used by the FDA for an approved drug, because “medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.” The warning is placed at the top of the PDR and “package insert” description of the drug and highlighted with a “black box,” thus the name. They are impossible to miss if one looks up the drug description in the PDR.

Yet the drugs are often used anyway, sometimes without the doctor even being aware that the drug carries such a warning. If there is no adverse outcome, it matters not. However, should something bad happen, the physician will be expected to 1) have been aware of the existence of the black box warning and 2) to have thoroughly documented his or her rationale for using the drug despite the warning.

The ideal documentation would be a full written informed consent, including the risks of the drug as well as the benefits, plus a discussion of reasonable alternatives available, including no treatment at all.

A physician should also be particularly careful if a patient requests a drug that may carry a black box warning, because it may be a newer  drug or one otherwise unfamiliar to the doctor – likely for good reason.

The most effective way for a physician to keep abreast of such drugs is to use an electronic prescribing system that automatically alerts the doctor if a medication with significant risks or warnings is being ordered or prescribed. Current data is unavailable, but recent articles suggest that over 8% of new drugs are approved with a black box warning already attached.

Drugs with black box warnings can be viable treatment options so long as the proper steps are followed and the matter is thoroughly documented in the patient’s record.

Wikipedia, somewhat surprisingly, actually has a well-written summary and examples of drugs with black box warnings. If you don’t know if a drug carries a “black box warning,” just check the PDR.

Leave a Comment