Safety Alerts & Recalls

What does this mean?

These added warnings for tramadol containing products (Ultram and Ultracet) have been known for some time and are already included in the labeling for the long-acting product Ultram ER. Tramadol products are used to treat moderate to moderately severe chronic pain and for most patients the benefits of pain relief will continue to outweigh the risks of the medicine.

However, if you are taking medicines for anxiety or sleep or antidepressant drugs, or if you use alcohol in excess, or if you suffer from emotional disturbance or depression, you may wish to review the tramadol safety concerns with your doctor.

If you take a tramadol product (Ultram, Ultram ER, Ultracet), you should watch for signs of new or worsening depression, suicidal thoughts or behavior, any unusual changes in mood or behavior, excessive drowsiness or confusion, or difficulty breathing and report any new symptoms immediately to your doctor or other health care professional. If you are experiencing suicidal thoughts and behaviors and need help right away, the following national suicide hotlines are available in the U.S. to help you: 1-800-SUICIDE (1-800-784-2433) and 1-800-273-TALK (1-800-273-8255).

If you have questions or concerns about this safety information or about your medicine, please follow up with your doctor or other healthcare professional. As with any medicine, you should not make changes to your pain medicine without first talking to your doctor or other healthcare professional. Adjusting your dose or stopping this medicine suddenly may cause serious problems.

Ultram and Ultracet Prescribing Information Updated

Ortho-McNeil-Janssen and the FDA notified healthcare professionals about recent changes in the Warnings section of the prescribing information for the pain medicine tramadol, also sold under the brand name Ultram and as the acetaminophen combination product called Ultracet. The additional warnings are already included in the prescribing information for Ultram ER, the long-acting tramadol product.

The strengthened Warnings information stresses the risk of suicide for patients who are addiction-prone, taking medicines for anxiety or insomnia, or taking antidepressant drugs and also warns of the risk of overdosage.

Tramadol-related deaths have occurred in patients with a previous history of emotional disturbances, depression, or suicidal ideation or attempts, as well as a history of misuse of alcohol, medicines for anxiety and insomnia, and other drugs that act on the central nervous system. Tramadol may have an increased risk of side effects when used together with alcohol, other narcotic pain medicines, or illicit drugs.

The prescribing information for tramadol also warns that some patients may develop a tolerance or may try to abuse this medicine and some patients may experience withdrawal symptoms when suddenly stopping a tramadol containing medicine.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-05-25
Last Updated: 2010-05-25

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