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Seizures Reported With Tramadol FREE

Laura H. Kahn, MD, MPH; Raymond J. Alderfer, MD, MPH; David J. Graham, MD, MPH
JAMA. 1997;278(20):1661-1661. doi:10.1001/jama.1997.03550200037026
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To the Editor.  —Tramadol hydrochloride (Ultram, McNeil Pharmaceutical, Spring House, Pa) is a centrally acting, synthetic, opioid analgesic that was approved for marketing in the United States in March 1995 for the treatment of moderate to moderately severe pain. The recommended adult dosage is 50 mg to 100 mg every 4 to 6 hours, not to exceed 400 mg/d.1Within the first year after marketing approval in the United States, the Food and Drug Administration (FDA) received 83 reports of seizures among patients using tramadol. This led to labeling changes and issuance of a "Dear Doctor" letter.2 During tramadol's second year on the market, the FDA received more than 200 reports of seizures. We describe the clinical features of seizure cases reported for tramadol.From the FDA's database of adverse drug events,3 we retrieved all domestic US reports for tramadol coded for seizures that the FDA had

REFERENCES

Physicians' Desk Reference. Montvale, NJ: Medical Economics Books; 1996.
 J&J Ultram Dear Doctor letter advises of seizures and drug abuse . FDC Reports . 1996;;58:1.
Baum C, Kweder SL, Anello C.  The spontaneous reporting system in the United States . In: Strom BL, ed. Pharmacoepidemiology . New York, NY:John Wiley & Sons Inc; 1994;:125-155.
Dean AG, Dean JA, Coulombier D, et al. Epi Info, version 6.1. Atlanta, Ga: Centers for Disease Control and Prevention; 1995.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

Physicians' Desk Reference. Montvale, NJ: Medical Economics Books; 1996.
 J&J Ultram Dear Doctor letter advises of seizures and drug abuse . FDC Reports . 1996;;58:1.
Baum C, Kweder SL, Anello C.  The spontaneous reporting system in the United States . In: Strom BL, ed. Pharmacoepidemiology . New York, NY:John Wiley & Sons Inc; 1994;:125-155.
Dean AG, Dean JA, Coulombier D, et al. Epi Info, version 6.1. Atlanta, Ga: Centers for Disease Control and Prevention; 1995.
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To understand the clinical management of acute heart failure syndromes.
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