New warnings about Ultram - tramadol

Healthfacts, June, 1996

Ortho-McNeil has sent a Dear Doctor letter alerting prescribers to serious adverse effects and abuse potential of the centrally acting analgesic Ultram (generic name: tramadol). Ultram was approved a year ago for treatment of moderate to moderately severe pain (JAMA, 24 April 1996).

Since Ultram's approval in March 1995, the FDA has received reports of 83 adverse events in the U.S. involving seizures or convulsions, some occurring after only one dose of the drug. In most cases there was a predisposing factor of concomitant medication with antidepressants, such as tricyclics (some generic examples are imipramine, amitriptyline) and selective serotonin uptake inhibitors (some brand name examples are Prozac and Zoloft). The updated drug label warns about Ultram's potential for serious drug interaction with all antidepressant medications, antipsychotics and other drugs known to reduce the seizure threshold. The warning section of the drug label has also been modified to include new cautions about possible extreme allergic reactions, especially in persons with known adverse reactions to codeine and other opioids. Eleven such reports were received by the FDA.

In addition there have been 115 reports of adverse events described as drug abuse, dependence, withdrawal or intentional overdose. New drug labeling warns that Ultram, which is not a controlled substance, is not recommended for persons with a history of addiction or opioid dependence. The last new caution added to the label is that the recommended single and daily dosages of Ultram should not be exceeded in attempts to obtain better pain relief.