Antidepressant prescribing information updated to include warning of seizures, death
By JENNIFER WALKER-JOURNEY

Date: December 3rd, 2009

Psychiatric healthcare professionals are being alerted by the Food and Drug Administration (FDA) that Norpramin (desipramine hydrochloride),a medication used to treat depression, should be used with extreme caution with patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The new WARNINGS and OVERDOSAGE sections also include a warning that seizures precede cardiac dysrhythmias and death in some patients.

Norpramin, made by Sanofi-Aventis, is a tricycline type of oral medication used to treat a variety of conditions including depression and other mental/mood disorders. It also has been used in the treatment of bulimia and attention deficit disorders, as well as to help cope with cocaine withdrawal. Tricycline antidepressants are thought to work by affecting the levels of the brain’s natural chemical messengers, called neurotransmitters, and adjusting the brain’s response to them.

According to the updated prescribing information for Norpramin, overdose of desipramine has resulted in a higher death rate compared to overdoses of other tricyclinic antidepressants.

Patients who use Norpramin are advised to discuss their medication and family history with their psychiatric or general health care professional. Adverse events occurring in connection with the use of Norpramin should be reported to the FDA’s MedWatch Reporting System at www.fda.gov/medwatch.

For more information, please refer to the FULL PRESCRIBING INFORMATION for Norpramin at www.sanofi-aventis.us for a complete discussion of the WARNINGS, OVERDOSAGE, and DOSAGE AND ADMINISTRATION for Norpramin.

Source: FDA

Related News