Aanpassing bijsluitertekst Tramadol VS vanwege verslaving en zelfmoord

De bijsluiter tekst van Tramadol in de VS gaat veranderen. Dit gebeurd vanwege een vergrote kans op zelfmoord en verslaving bij het gebruik van opiaten. (het nieuws bericht hier onder…)

A warning about the risks of suicide associated with use of the opioid analgesic tramadol in certain patients has been added to the drug’s prescribing information, the Food and Drug Administration announced May 25.

The warnings section advises clinicians against prescribing tramadol to patients who are suicidal or prone to addictions, emphasizing that patients who are addiction-prone or taking tranquilizers or antidepressant drugs are at risk of suicide if they are taking tramadol. Tramadol-related deaths have been reported in patients with histories of emotional disturbances or suicidal ideation or attempts, and histories of misuse of tranquilizers, alcohol, and other CNS-active drugs, according to an FDA statement.

Tramadol, a centrally acting synthetic opioid analgesic approved for the management of moderate to moderately severe chronic pain, is marketed as Ultram and Ultracet (tramadol with acetaminophen).

The revised warnings are summarized in “Dear Healthcare Professional” letters for Ultram and for Ultracet dated in April, from PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., that markets tramadol. The revised label also advises that tramadol tablets be prescribed “with caution” to patients who are treated with tranquilizers or antidepressant drugs, patients who abuse alcohol, and those who have emotional disturbances or depression.

The letter for Ultracet also points out the risks of acetaminophen overdoses, including hepatic necrosis that can lead to hepatic failure and death.

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