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In December 2001 the Food and Drug Administration (FDA) strengthened the warnings and precautions sections of the professional product labeling, or “package insert,” for droperidol (INAPSINE), an injectable tranquilizer frequently used as premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Droperidol alters the heart’s electrical conductivity, known as QT prolongation, which has led to a type of fatal heart rhythm disturbances known...
In December 2001 the Food and Drug Administration (FDA) strengthened the warnings and precautions sections of the professional product labeling, or “package insert,” for droperidol (INAPSINE), an injectable tranquilizer frequently used as premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Droperidol alters the heart’s electrical conductivity, known as QT prolongation, which has led to a type of fatal heart rhythm disturbances known as torsades de pointes.
Specific changes to droperidol’s labeling include a “black box” warning, the most serious warning that the FDA can require. The text of the new warning appears at the end of this article.
Unfortunately, American patients have been left to face the risk of a fatal heart rhythm disturbance from droperidol while British patients have been spared this possibility. In March 2001, eight months before the FDA announced the new warning for droperidol, British drug regulatory authorities banned the drug from the market. Droperidol joins a growing list of drugs that have been banned in foreign countries for safety reasons but remain available in the U.S. These include: levomethadyl (ORLAAM), used to manage narcotic addiction; pemoline (CYLERT), a drug used for hyperactivity in children; the fluoroquinolone antibiotic trovafloxacin (TROVAN); and the Parkinson’s disease drug tolcapone (TASMAR).
A more business-friendly FDA materialized after Congress passed legislation allowing industry to directly fund the drug approval process, thus improving the economic performance of the drug companies. This law and the new FDA attitude it has engendered apparently created an additional adverse effect for the public. Rather than banning redundant, dangerous drugs such as droperidol and the others listed above, as other countries have done, the FDA asks for label changes and leaves the drugs on the market. This may be good for a company’s financial health, but poor for the public’s health.
What You Can Do
Before you or a family member give informed consent prior to a surgical procedure, ask your doctor and the anesthesiologist about using a less dangerous alternative to droperidol.
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Cases of QT prolongation and/or torsades de pointes have been reported in patients receiving INAPSINE at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. Due to its potential for serious proarrhythmic effects and death, INAPSINE should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with INAPSINE. Based on these reports, all patients should undergo a 12‑lead ECG prior to administration of INAPSINE to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, INAPSINE should NOT be administered. For patients in whom the potential benefit of INAPSINE treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2‑3 hours after completing treatment to monitor for arrhythmias. INAPSINE is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome. INAPSINE should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect. |
