PPHN - Consumer Justice Foundation

Effexor and PPHN

Effexor falls into the category of SNRI antidepressant medications, or serotonin-norepinephrine reuptake inhibitors. These drugs work by preventing the “reuptake” of serotonin and norepinephrine, two neurotransmitters in the brain responsible for affecting mood. The active ingredient in Effexor is venlafaxine, and the drug was approved by the FDA in 1993. Although Effexor has only been approved for the treatment of major depressive disorder, social anxiety disorder and generalized anxiety disorder, it is often prescribed for off-label purposes as well, including the treatment of panic disorder and diabetic neuropathy. Effexor is currently manufactured by Wyeth Pharmaceuticals, a division of Pfizer, Inc., and as of 2007 was the sixth most frequently prescribed antidepressant on the U.S. market, with 17.2 million prescriptions filled.

Despite the fact that Effexor has become one of the most popular antidepressant drugs available, the safety of the medication may be re-evaluated with the release of a number of antidepressant birth defect studies in recent years. According to this body of research, infants whose mothers take certain antidepressant medications during pregnancy may have a significantly increased risk of being born with major birth defects, including a life-threatening condition called persistent pulmonary hypertension of the newborn.

Persistent Pulmonary Hypertension of the Newborn

Persistent pulmonary hypertension of the newborn, or PPHN, is a congenital birth defect in which a child’s circulation continues to bypass the lungs after birth. When a child is in the womb the lungs are not yet needed, because the placenta provides the baby with a sufficient supply of oxygen through the umbilical cord. When the child is born, the circulatory system adapts to breathing air and the lungs are now required in order for the exchange of oxygen and carbon dioxide to take place. However, in children with PPHN, the body fails to make this change and blood flow continues to bypass the lungs, depriving the body’s vital organs and tissues of their essential supply of oxygen.

PPHN Signs and Symptoms

Even though babies with PPHN can breathe, the oxygen in the breathed air will not reach the bloodstream to be distributed to the rest of the body. In addition, blood returning from the body is unable to enter the lungs properly and therefore returns to the heart in an oxygen-poor state. Common symptoms of PPHN include respiratory distress, rapid breathing, rapid heart rate, heart murmur, cyanosis (bluish tint to the skin), and low oxygen levels even with oxygen treatment.

PPHN Treatment and Prognosis

With proper medical treatment, some instances of PPHN may be treatable and reversible while others can be permanent and may even lead to fatality. The major goal of PPHN treatment is to increase the amount of oxygen being delivered to the body in order to prevent devastating organ damage. Common treatment methods for PPHN include:

  • 100% supplemental oxygen
  • Assisted ventilation
  • Nitric oxide treatment
  • High frequency oscillatory ventilation
  • Extracorporeal Membrane Oxygenation (ECMO) in cases of major heart and lung failure

Although advancements in medical technology have improved the survival rate for infants with PPHN, some children may continue to deliver insufficient amounts of oxygen to the rest of the body, even with early diagnosis and aggressive treatment. In some cases, PPHN may lead to catastrophic conditions like heart failure, kidney failure, brain hemorrhage, shock, seizures and even death.

Potential Effexor Birth Defects and FDA Warnings

A number of birth defect studies have been published in recent years which have concentrated specifically on SSRI antidepressants, or selective serotonin reuptake inhibitors. These drugs are very similar to SNRIs like Effexor, but act upon serotonin alone, instead of both serotonin and norepinephrine, in order to relieve depression and improve mood. Although research concerning SNRI antidepressants in particular is lacking, researchers may be able to examine the findings of SSRI birth defect studies in order to evaluate the potentially harmful nature of SNRI antidepressants like Effexor. One of the most revealing of these studies was published in 2006 in the New England Journal of Medicine, in which researchers found a connection between certain antidepressants and the development of PPHN among infants. According to the report, women who took SSRI antidepressants during the third trimester of pregnancy were an alarming six times more likely to give birth to infants with PPHN, compared to women who did not take the drugs while pregnant. Shortly after this study was released, the FDA issued a public health advisory warning patients and physicians about the potential connection between SSRIs and PPHN. The FDA also required all SSRI sponsors to update their drug warning labels to include potential pregnancy precautions like PPHN.

Additional studies have been conducted recently in credible medical journals which have suggested a potential connection between the use of certain antidepressants during pregnancy and the development of major birth defects among exposed infants. In 2007, the NEJM published two more studies in which infants exposed to SSRI antidepressants in utero were found to be nearly twice as likely to be born with birth defects like club foot, limb defects, and anal atresia, and more than twice as likely to develop omphalocele, anencephaly, and craniosynostosis. The studies also found a possible connection between these drugs and cleft lip, cleft palate, and neural tube birth defects. Another study published in 2010 in the American Journal of Nursing found an increased risk of heart defects, particularly atrial septal defects and ventricular septal defects, among infants exposed to certain antidepressant drugs during pregnancy.

Effexor Use and Pregnancy

Effexor has been labeled a pregnancy category C medication, a classification reserved for drugs with the potential to cause serious harm to a human fetus when taken during pregnancy. If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your healthcare provider immediately. It may be unsafe to suddenly discontinue use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find an alternative method of treating your condition. Unfortunately, the majority of birth defects are established during the first trimester of pregnancy, before many women are even aware they are pregnant. Because nearly half of all pregnancies are unplanned, all women of childbearing age taking Effexor may be at risk of causing irreversible harm to their unborn child without their knowledge.

An Effexor Attorney Can Help

Birth defects like PPHN are extremely serious and can cause life-altering and even fatal complications for a newborn child. If you or a loved one has suffered from PPHN and you believe Effexor to be the cause, contact an Effexor attorney to discuss your legal options. You may have grounds to file an Effexor lawsuit against Wyeth Pharmaceuticals (Pfizer), in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. By filing a defective drug lawsuit, birth defect victims can also bring attention to the need for safer medications on the market.

Victims of serious injuries resulting from the proper use of a potentially dangerous drug are not at fault and should not be held responsible for the negative consequences associated with their injuries. Unfortunately, this is often exactly what ends up happening, as some pharmaceutical companies deny liability for adverse side effects sustained by consumers of their products. In fact, some drug companies are actually aware of the harmful nature of their medications, but intentionally conceal this information in order to protect their own interests and avoid negative consequences. In turn, millions of consumers are exposed to life-altering and potentially fatal injury or illness, which could have been avoided had the manufacturing company taken the appropriate steps to prevent unnecessary harm. The only way to protect your rights and stand up to big drug companies is to hire a qualified Effexor lawyer to represent your case.

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