Ortho-McNeil's revised 2001 product package insert for Ultram states, "Tramadol may induce psychic and physical dependence of the morphine type (mu-opioid). Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence" (italics in original, emphasizing 2001 addition). The risk for patients with a history of substance abuse has been observed to be higher. (10)

REFERENCES

(1.) Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999; 281:824-829.

(2.) Brinker A, Bonnel RA, Beitz J. Abuse, dependence, or withdrawal associated with tramadol. Am J Psychiatry 2002; 159:881-882.

(3.) Adverse Event Reporting System. Freedom of Information Report. Rockville, Md: Office of Drug Safety, Food and Drug Administration: search November 1997 to September 2004.

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