MADISON, N.J., March 28 /PRNewswire-FirstCall/ -- Wyeth announced today the nationwide launch of its Dialogues: Time to Talk(TM) program in Spanish -- bringing a unique education and support program to Spanish-speaking patients with depression who are taking EFFEXOR XR(R) (venlafaxine HCl).
Depression is a serious medical condition that affects roughly eight million Hispanics, who are significantly more likely to be chronically depressed than non-Hispanics, according to a recent study funded by the National Institutes of Mental Health. Further, a Surgeon General’s report on mental health suggests Hispanics may not be receiving adequate treatment.
“Patient education and support are important components of treatment of patients with depression,” says Geno Germano, Executive Vice President and General Manager for Wyeth Pharmaceuticals. “However, Hispanic patients may face language barriers in communicating with non-Spanish-speaking caregivers and understanding English-only patient support tools. The Spanish Dialogues: Time to Talk program is intended to help fill an unmet need in this community by providing patients with education and support materials to help them achieve their treatment goals with their doctors.”
Patients who enroll in the Spanish Dialogues: Time to Talk program will receive educational materials that have been developed in consultation with physicians and patients to help address common therapeutic needs of patients taking EFFEXOR XR for depression. Patients are provided additional support to aid in their treatment through both a Spanish Dialogues: Time to Talk Web site, http://www.HoraDeHablar.com, and optional telephone-support services, which include three calls from bilingual nurses and unlimited calls to a helpline. Patients taking EFFEXOR XR who opt for telephone support services are asked a series of questions by phone and can enter responses via the touch pad. Within 48 hours, the responses are sent to the patient’s physician regarding the patient’s mood, sleep levels, energy, appetite, concentration, social functioning, self-harm and medication adherence.
“This program is particularly important for Hispanic patients who may have difficulty communicating with non-Spanish-speaking physicians and may be vulnerable to early discontinuation of treatment, which may lead to future episodes of depression,” says Pedro Delgado, M.D., Chair of the Department of Psychiatry, University of Texas Health Science Center at San Antonio. “The Dialogues: Time to Talk program seeks to help open communication channels for this community while providing educational resources.”
EFFEXOR/EFFEXOR XR is not indicated for use in pediatric populations and, as such, the Dialogues: Time to Talk program will not be made available to patients under the age of 18.
EFFEXOR XR(R) IMPORTANT TREATMENT CONSIDERATIONS
Suicidality in Children and Adolescents
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. Anyone considering the use of EFFEXOR XR(R) (venlafaxine HCl) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. EFFEXOR XR is not approved for use in pediatric patients.
-- EFFEXOR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). -- Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. Patients should be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms. -- Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Post-marketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended. -- Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually. -- The most common adverse events reported in EFFEXOR XR short-term placebo-controlled depression, generalized anxiety disorder (GAD), social anxiety disorder (SAD), and/or panic disorder (PD) trials (incidence greater than or equal to 10 % and greater than or equal to 2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating. Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Wyeth
CONTACT: Media - Gwen Fisher, Wyeth Pharmaceuticals, +1-484-865-5160, orInvestors - Justin Victoria, Wyeth, +1-973-660-5340
Web site: http://www.wyeth.com/
