Wyeth Affirms The Safety Profile Of Effexor XR

Main Category: Depression
Also Included In: Anxiety / Stress;  Psychology / Psychiatry;  Mental Health
Article Date: 15 Jul 2006 - 0:00 PDT

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In response to reports regarding Effexor XR® (venlafaxine HCl), an antidepressant approved for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder, Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), affirms that no causal link between Effexor XR and homicidal thoughts and actions has been established. The Company proactively performs comprehensive reviews of both clinical and post-marketing surveillance data and acts responsibly and in full accordance with regulatory requirements in disclosing safety data regarding its medicines.

"Depression is a serious, complex disease that can be difficult to treat, and patients with depression can have other serious co-morbid psychiatric illnesses," says Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs, Wyeth Pharmaceuticals. "Homicidal thoughts may occur in patients with psychiatric conditions whether or not a patient is being treated with psychotropic medications.

"It is unfortunate that unsubstantiated and irresponsible allegations have been made that may create undue concern and confusion on the part of patients who benefit from treatment with Effexor XR," Dr. Camardo continues. "However, we always encourage patients to discuss any concerns or confusion they may have with their treating physicians."

Other Material Facts

-- As required by regulations, Wyeth documents and reports safety findings from its clinical trials and post-marketing surveillance data to health boards and regulatory agencies around the world. In addition, we conduct periodic safety reviews to ensure the safety profile represented in labeling is current and accurate.

-- The term "homicidal ideation" first became part of the Effexor XR label in the section titled "Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR," in November 2005 upon FDA approval of Effexor XR for the treatment of panic disorder. As part of the application for the panic disorder indication, Wyeth provided the FDA with data that included homicidal ideation in a clinical trial for Effexor XR.

-- Homicidal ideation was listed in the approved label in the section titled "Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR." Homicidal ideation is noted under a subheading titled "Nervous System," and is categorized as "rare." This section of the FDA-approved label states, "although the events reported occurred during treatment with venlafaxine, they were not necessarily caused by it."

-- Health authorities, including the FDA, recognize an important distinction between Adverse Reactions and Adverse Events. Adverse Reactions are believed to occur as a result of using a medication, whereas Adverse Events have not been proven to occur as a result of using a medication. An Adverse Event may or may not be causally related to treatment.

-- There is no scientific evidence that establishes a causal link between Effexor XR and homicidal ideation. The Company has appropriately communicated the safety profile of Effexor XR through its existing label.

In bringing its medicines to market, one of Wyeth's chief concerns is patient safety. Wyeth is confident that a wealth of clinical data and experience over more than 11 years in over 12 million patients continue to support the appropriate use of Effexor XR in treating adult patients with major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.

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 (venlafaxine HC1) 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.

-- The development of potentially life-threatening serotonin syndrome may occur when EFFEXOR XR is coadministered with other drugs that may affect the serotonergic neurotransmitter systems. Concomitant use of EFFEXOR XR with MAOIs is contraindicated. If concomitant use of EFFEXOR XR with an SSRI, SNRI, or a triptan is clinically warranted, careful observation of the patient is advised. Concomitant use of EFFEXOR XR with tryptophan supplements is not recommended.

-- Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Postmarketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended.

-- Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.

-- 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 >10% and >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.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

http://www.wyeth.com