This newest research appears to address some of the limitations of previous studies and bolsters the claims of people seeking to hold SSRI manufacturers accountable for PPHN-related injuries.
Newport Beach, CA (PRWEB) January 16, 2012
As part of its ongoing investigation of legal claims involving certain antidepressant medications that may cause birth defects and other adverse consequences to infants whose mothers ingested the drugs during pregnancy, The Senators (Ret.) Firm™, LLP, commented today on a new study in the British Medical Journal which adds to growing scientific evidence that some of the drugs may significantly increase the risk of serious lung disorders in newborns.
In the new study, researchers reviewed more than 1.6 million births from 1996-2007 in several Scandinavian countries. After controlling for numerous risk factors, researchers found “a robust association between exposure to SSRIs in late pregnancy and persistent pulmonary hypertension of the newborn.” The disorder, also known as PPHN, is a rare but life-threatening condition in which a newborn's circulatory system does not provide blood to the lungs. The study indicates that SSRI medications taken in the late stages of pregnancy may double the risk of PPHN.
Depression in women is most common during their childbearing years, and it has been estimated that about 13% of women in the United States have taken an antidepressant drug during pregnancy. In the past 20 years, a special class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) has become a mainstay of treatment in women with depression. These include Zoloft (sertraline), Lexapro (escitalopram), paroxetine, Prozac (fluoxetine), Celexa (citalopram), Symbyax (fluoxetine and olanzapine), and Effexor (venlafaxine), among others. However, concerns persist about the safety of SSRIs for the developing fetus.
Because of ethical concerns, the FDA does not require drug manufacturers to conduct pre-marketing clinical studies of drugs in pregnant women, and instead primarily relies on animal testing which may not reflect the actual risk in humans. As a result, the evidence for SSRI-related birth defects has been based on post-marketing studies. A number of studies in and outside the U.S. on various SSRIs used during pregnancy have been conducted, and the results of that research have been hotly debated by drug companies, researchers, and the medical community. “This newest research appears to address some of the limitations of previous studies and bolsters the claims of people seeking to hold SSRI manufacturers accountable for PPHN-related injuries,” noted Thomas M. Moore, Managing Partner of The Senators (Ret.) Firm.
Over the past several years, the FDA has issued a number of alerts regarding the potential effects of SSRIs on fetal development and has required stronger warnings on certain products. “The ‘catch-22’ with this problem is that major depression and bipolar illness are significant health concerns, and doctors need the ability to prescribe antidepressants when the benefits of the drugs truly outweigh their risks,” said former California State Senator Martha Escutia, a co-founding member of The Senators Firm and past Chair of the California State Senate Health Committee. “However, it is equally important that doctors obtain accurate data from drug manufacturers as to what the true risk is, so that those women who are, or who may become, pregnant can make an informed decision based on their own unique circumstances.”
The Senators (Ret.) Firm℠, LLP provides legal representation to injured consumers through an integrated and collaborative approach, combining years of experience in legislative, regulatory and complex litigation arenas. The lawyers of The Senators (Ret.) Firm™, LLP are committed to providing clients with practical and effective solutions to complex legal problems. We place a premium on professionalism, integrity, communication and responsiveness to client needs.