The FDA is warning doctors not to prescribe the painkillers Ultram and Ultracet to patients who have shone themselves to be suicidal or vulnerable to addiction.
The FDA announced on Tuesday that it is contraindicating the tramadol-based opioid painkillers Ultram and Ultracet for these users after reports of deaths and overdoses, and due to its ability to cause central nervous system depression.
A “Dear Healthcare Professional” letter has been sent for Ultram and Ultracet in conjunction with Ortho-McNeil-Janssen, the manufacturer, alerting doctors to the new labeling changes and contraindications. The letters did not say how many deaths had been attributed to the painkillers.
Ultram (tramadol hydrochloride) and Ultracet (tramadol hydrochloride/acetaminophen) are synthetic opioid analgesic painkillers approved for the treatment of moderate to moderately severe chronic pain. However, FDA drug safety reviewers say that the drugs have been related to deaths that have occurred in patients with a history of emotional disturbances, suicide attempts, as well as drug and alcohol addictions.
The FDA says Ultram and Ultracet overdoses can result in central nervous system depression, respiratory depression and death. They are also prone to abuse and illegal use.
The new label changes contraindicate the use of the Ultram and Ultracet for patients who are suicidal or addiction-prone. The warnings also suggest doctors use caution in prescribing the drugs to patients who are taking trauquilizers or antidepressants, as well as to patients who drink alcohol to excess and who suffer from emotional disturbance or depression.
The labels will carry extensive information on Ultram and Ultracet misuse and abuse potential, the possibility of patients seeking the drug for criminal intent, and warnings on the possibilities and effects of Ultracet and Ultram overdoses.