Reference: 1. Emsam [prescribing information]. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients age 65 and older. When combined with certain foods or drinks -- red wines, lunch meats, cheese, fava beans, Italian green beans are all on the restricted list -- oral MAO inhibitors can trigger sudden spikes in blood pressure causing a hypertensive crisis.
The Emsam patch will be marketed in doses of 6, 9, and 12 mg delivered transdermally over 24 hours. It is a three-layer matrix consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.
In clinical studies the patch demonstrated safety and efficacy for treatment of major depressive disorder in two six- to eight-week week studies and also in a longer-term study of patients.
Dolan, chief executive officer, Bristol-Myers Squibb Company. Oral MAOI antidepressants pass through the digestive tract, thus inhibiting intestinal MAO-A, which is needed to break down tyramine,1 a substance found in certain foods and beverages such as aged cheese and tap beer.
While most foods contain negligible amounts or no tyramine, a few food products may contain large amounts of tyramine that represent a potential risk for patients with significant inhibition of intestinal MAO-A resulting from administration of MAO inhibitors. As a result, initial exposure of the drug to the digestive tract is minimized. The benefit of maintaining patients with MDD on therapy with EMSAM after achieving a responder status for an average of 25 days was demonstrated in controlled clinical trial.
Approximately 52 percent of the EMSAM-treated patients as well as about 52 percent of the placebo-treated patients had discontinued treatment by week 12 of the double-blind phase. Most were mild to moderate in severity with only two percent resulting in discontinuation. Patients should be instructed to inform all of their health care professionals that they are using EMSAM, and not to stop or change treatment with EMSAM without consulting their health care professional.
Important Safety Information Antidepressants increased the risk of suicidal thinking and behavior suicidality in short-term studies in children and adolescents with major depressive disorder MDD and other psychiatric disorders. All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at time of dose changes, either increases or decreases.
Families and caregivers should be advised for the need for close observation and communication with the prescriber. Pooled analyses of short-term 4 to 16 weeks placebo-controlled trials of nine antidepressant drugs SSRIs and others in children and adolescents with major depressive disorder MDD , obsessive compulsive disorder OCD , or other psychiatric disorders a total of 24 trials involving over 4, patients have revealed a greater risk of adverse events representing suicidal thinking and behavior suicidality during the first few months of treatment in those receiving antidepressants.
The average risk of such events in patients receiving antidepressants was 4 percent, twice the placebo risk of 2 percent.
No suicides occurred in these trials. Due to the potential for serotonin syndrome, which is potentially life-threatening, EMSAM should not be used with the following antidepressants: selective serotonin reuptake inhibitors SSRIs , dual serotonin and norepinephrine reuptake inhibitors SNRIs , tricyclic antidepressants TCAs , monoamine oxidase inhibitors MAOIs , mirtazapine, and bupropion; meperidine and analgesics such as tramadol, methadone, propoxyphene, and pentazocine; the antitussive dextromethorphan; cyclobenzaprine; oral selegiline; and St.
The use of EMSAM is contraindicated for use with sympathomimetic amines, including amphetamines as well as cold products and weight-reducing preparations that contain vasoconstrictors e. Patients taking EMSAM should not undergo elective surgery requiring general anesthesia or be given local anesthesia containing sympathomimetic vasoconstrictors.
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