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New Effexor Generic Approved, Risks Are Similar

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Washington, DCConcerns over potential Effexor side effects—including heart damage in newborns and various other birth defects that occur when expectant mothers take Effexor antidepressants—heightened late last month with the approval of an Effexor generic.

A release posted on the official website of the US Food and Drug Administration (FDA) on 6/29/10 refers to the approval the day prior of a generic form of venlafaxine hydrochloride, otherwise known as Effexor XR (extended release) capsules.

TEVA Pharmaceuticals, of North Wales, Pennsylvania, has been given the nod to manufacture the generic version of Effexor in 37.5 milligram, 75 milligram and 150 milligram strengths.

"The approval of this widely used antidepressant is another example of the FDA's efforts to increase access to safe and effective generic drugs," wrote Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in the FDA release. "Access to treatments for depression is important because depression can interfere with a person's daily life and routine, which can significantly affect relationships with family and friends."

While the label may differ due to proprietary "patents and/or exclusivity held by the Effexor manufacturer, Wyeth Pharmaceuticals Inc.," the FDA maintains that generic venlafaxine hydrochloride will carry the same safety warnings as Effexor XR.

That means generic Effexor will also carry the same risks as brand name Effexor, including the potential for rare heart defects in newborn children.

The FDA news release lists many of the potential side effects inherent with Effexor, including "feelings of sadness, anxiety, emptiness, hopelessness, guilt, worthlessness or helplessness. Irritability and restlessness are also common symptoms of depression. Many people with depression lose interest in activities or hobbies and feel tired all the time.

"The drug has a boxed warning indicating that antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. The warning also notes that depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions."

There is no reference in the FDA release with regard to the potential for Effexor birth defects. However, various studies have suggested that expectant mothers who take Effexor and other selective serotonin reuptake inhibitor (SSRI) antidepressants during the first 12 weeks of pregnancy extend a 40 percent greater risk of malformations to their unborn children. Health Canada, the Canadian health authority, warned expectant mothers and women who are trying to become pregnant to steer clear of Effexor and similar SSRIs. That was in 2006.

Four years later, in 2010, new research suggests that staying with Effexor and other SSRI drugs through the second and third trimester can contribute to developmental delays.


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