Black Box Warnings

April 18th, 2011
by reuben in pharmacology/physiology

I have watched droperidol disappear from my ED’s formulary and it makes me sad. So good for so many purposes, so convenient to use, so safe, so cheap. It had to go. The black box stamp of death.

Except that I just learned that there has been a black box warning on all fluoroquinolones since July 2008. Not only has cipro and levaquin use continued unabated, no one is even talking about their black box, I hadn’t even heard of it until just now. What else has a black box that I didn’t know about? Well, it’s an impressive list of drugs. Here are some highlights for the emergency doc:

Clindamycin: “Clindamycin phosphate therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS and USAGE section.”

Clopidogrel: “Poor metabolizers with acute coronary syndrome or undergoing percutaneous coronary intervention treated with Plavix at recommended doses exhibit higher cardiovascular event rates than do patients with normal CYP2C19 function.”

Factor VIIa: “Clinical studies have shown increased risk of arterial thromboembolic adverse events with this product when administered outside the current approved indications. Fatal and non-fatal thrombotic events have been reported.”

Dihydroergotamine: “Serious and/or life threatening peripheral ischemia has been reported with coadministration of this drug with potent CYP 3A4 inhibitors (including protease inhibitors and macrolide antibiotics).”

Flumazenil: “Has been associated with seizures.”

Haloperidol: “Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.” “Analyses of seventeen placebo controlled trials (modal duration of 10 weeks, largely in patients taking atypical antipyschotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients.” “Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.” “This drug is not approved for the treatment of patients with dementia-related psychosis.” How about that. Meanwhile, haldol rains from the sky in EDs the world over, especially on patients with dementia-related psychosis. And for good reason.

NSAIDs: “NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.” “NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.” Yes, NSAIDs. Ibuprofen. Black friggen box. And ketorolac has its own, massive black box.

Metformin: Huge black box around lactic acidosis. Am I the only EP sending new diabetics home on metformin?

Methotrexate: God help you if you work in one of those EDs where you’re supposed to give methotrexate to ectopics without OB involvement.

Metronidazole: “Carcinogenic in mice and rats.” “Avoid unnecessary use.”

Midazolam: “Reports of respiratory depression, airway obstruction, desaturation, hypoxia, and apnea, particularly when used with concomitant CNS depressants (e.g.opioids).”

Nitroprusside: “Can cause significant drops in blood pressure leading to irreversible ischemic injury or death.”

Procainamide: “Limit the use of this drug to patients with life-threatening ventricular arrhythmias.”

Succinylcholine: “Cardiac Arrest has been reported resulting from hyperkalemic rhabdomyolysis, most frequently in infants or children (but has occurred in adolescents) with undiagnosed skeletal muscle myopathy or Duchenne’s muscular dystrophy.”

Warfarin: “Can cause major or fatal bleeding.” No shit.

And, of course there’s the droperidol black box. It’s interesting that everyone has freaked out about the droperidol black box, which has been aggressively refuted, while we continue to use other black boxed drugs without thinking twice.

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Responses to “Black Box Warnings”

  1. To complicate the droperidol black box situation, not only does Haldol have a none-QT-prolongation black box warning (as you note above) but also a none-black-box warning about QT-prolongation, and another warning that it is not approved for IV usage.

    http://www.rxlist.com/haldol-drug.htm#

  2. If only I could get our physicians to take some of these black box warnings as seriously as I do… ::sigh::

    walterhpdx at

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