Wyeth appears to comply with black box warnings

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Wyeth Comments on FDA Joint Advisory Committee

Antidepressant Safety Recommendation for Pediatric Population

2004-09-14 18:16 ET - News Release

MADISON, N.J., Sept. 14 /PRNewswire-FirstCall/ -- Wyeth

Pharmaceuticals, a division of Wyeth , supports the U.S. Food

and Drug Administration (FDA) Joint Advisory Committee's

recommendation to strengthen the product labels across the

antidepressant category regarding use in the pediatric

population. Wyeth will continue to provide safety information

broadly and in a consistent way to physicians, as well as work

with the FDA on its review of the safety and use of

antidepressants in the pediatric population. Wyeth will discuss

with the Agency how to implement the recommendations of the

Committee to provide warnings and additional information to

physicians, as well as to patients and their parents. The

Committee's recommendation will ensure continued access by

physicians to these drugs for children suffering from depression.

With more than two million children and adolescents in the

United States suffering from depression, it is critical that

physicians have treatment options that allow for the use of

antidepressants in the pediatric population if the physician

believes it to be appropriate, is aware of the significant safety

concern information, and is able to monitor these patients

appropriately.

" We must not lose sight of the research, which suggests that the

increased use of antidepressants may be associated with a

reduction in the number of suicides in the pediatric population.

Physicians need to assess the risks and benefits of

antidepressant therapy in order to make appropriate treatment

decisions for each patient, " says Moira Rynn, M.D., University of

Pennsylvania School of Medicine.

The EFFEXOR and EFFEXOR XR labels have always included

information on the possibility of a suicide attempt, which is

inherent in depression, and that close supervision of high-risk

patients should accompany initial drug therapy. Wyeth has and

will continue to take a leadership role in communicating

information to health care providers and consumers regarding

important safety information in the pediatric population. In August

of 2003, Wyeth sent a letter to over 450,000 health care

professionals advising them of the Company's decision to

update the prescribing information of EFFEXOR and EFFEXOR

XR to include a precaution about usage in children and

adolescents. Wyeth also updated its consumer Web site with

this important safety information. In June 2004, Wyeth sent a

letter to over 450,000 health care professionals to inform them

about the class labeling including the suicidality warning for

antidepressants requested by the FDA.

" It also is important to note that in clinical studies in adults with

depression, EFFEXOR/EFFEXOR XR showed no increase in the

emergence or worsening of suicidality on the HAM-D suicide

item score vs placebo, " says ph Camardo, M.D., Senior Vice

President of Medical Affairs, Wyeth Pharmaceuticals.

About EFFEXOR XR

EFFEXOR XR is a structurally novel antidepressant chemically

unrelated to any other available antidepressant.

EFFEXOR/EFFEXOR XR is contraindicated in patients taking

monoamine oxidase inhibitors (MAOIs). Both 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, impulsivity, akathisia, hypomania,

and mania have been reported in patients taking

antidepressants. Discontinuation or modification of therapy

should be considered 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. 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

short-term placebo- controlled depression trials and EFFEXOR

XR short-term placebo-controlled depression, generalized

anxiety disorder (GAD), and/or social anxiety disorder 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.

EFFEXOR XR was discovered and developed by Wyeth

Pharmaceuticals, the pharmaceutical division of Wyeth. The

product is also marketed by Wyeth Pharmaceuticals. The

immediate-release formulation was approved by the FDA in

1993; the extended-release (XR) formulation was approved in

1997. These medications are available only by prescription.

About 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 Health Care, and Fort Dodge Animal Health.

Wyeth

CONTACT: Media Contact, Petkus, +1-484-865-5140,

or de

Vane, +1-484-865-5139, both of Wyeth Pharmaceuticals, or

Investor Contact,

of Wyeth, +1-973-660-5340

Web site: http://www.wyeth.com/