The US Food and Drug Administration (FDA) announced yesterday that it has added the warning label of suicide risk to tramadol hydrochloride (Ultram) and tramadol hydrochloride/acetaminophen (Ultracet). Ultram and Ultracet are opioid analgesic used for moderate to severe pain (such as cancer and arthritis pain).
The revised labels instruct doctors not to prescribe tramadol to patients who are suicidal or addiction-prone, and to be careful when prescribing the medications to patients who
1) use alcohol excessively,
2) suffer from emotional disturbance or depression,
3) take tranquilizers or antidepressants.
Both drugs, Ultram and Ultracet, were found to intensify the effects of other opioids as well as alcohol and illicit drugs that depress the central nervous system.
To report adverse events related to the Ultram or Ultracet, you may contact MedWatch
1) By telephone at 1-800-FDA-1088,
2) by fax at 1-800-FDA-0178,
3) online at http://www.fda.gov/medwatch,
4) by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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