Rhode Island Parents Join Effexor MDL

In August 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated nine product liability lawsuits against Wyeth Pharmaceuticals, Inc. and parent company Pfizer, each alleging that the anxiety drug Effexor caused birth defects in children. All cases were transferred to the Eastern District of Pennsylvania, with Judge Cynthia M. Rufe assigned to oversee the proceedings.

Since then, more parents have joined the MDL with cases alleging similar claims—that Effexor caused birth defects. Rhode Island parents Kimberly Santos and Michael Hicks recently filed one of these lawsuits, claiming their son was born with serious birth defects after Santos took Effexor during her pregnancy.

Effexor Linked with Birth Defects

First approved by the FDA in 1993, Effexor (venlafaxine) is an antidepressant—part of a class of drugs called “serotonin-norepinephrine reuptake inhibitors (SNRIs).” Though similar to selective serotonin reuptake inhibitors (SSRIs) like Paxil and Zoloft, SNRIs act on not just serotonin, but on norepinephrine, too—both neurotransmitters in the brain. Both are associated with increasing feelings of well being, and are thought to be in low supply in patients with depression and anxiety.

SNRIs are believed to help relieve symptoms by increasing levels of serotonin and norepinephrine in the brain. Scientists theorize that more of these neurotransmitters help to make communication in the brain more efficient, improving mood and helping to stabilize emotional processes.

Parents Claim Effexor Caused Heart Defects

Santos alleges she took Effexor during her pregnancy, and was not aware of any potential risk to her unborn child. Had she known about them, she claims she never would have used the drug. Her son was born on August 4, 2006 with congenital heart problems, for which he was required to undergo surgery immediately after his birth.

Some studies have shown that taking Effexor and other antidepressants during pregnancy may increase risk of birth defects. In 2012, for instance, researchers analyzed data from the National Birth Defects Prevention Study, and found that mothers who took venlafaxine had a higher risk of some birth defects, including anencephaly (absence of a large portion of the brain and skull) and heart defects.

Another study published in 2012 found a 68 percent increase in overall risk of miscarriage in pregnant women using antidepressants like Effexor, and a number of other studies have linked antidepressants in general to heart, brain, limb, and abdominal birth defects.

Effexor Named as Category C

The FDA has named Effexor a pregnancy Category C drug, meaning it could potentially harm an unborn child, especially when used during the third trimester. In 2004, the label was updated with warnings advising parents that infants exposed to the drug in the third trimester developed complications requiring prolonged hospital support.

Parents filing lawsuits against Pfizer and Wyeth claim that the companies did not do enough to warn about the risks associated with the drug, and should have conducted additional safety studies to be sure it was okay for expectant moms to use.