Effexor is a prescription antidepressant medication which falls into the category of SNRIs, or serotonin-norepinephrine reuptake inhibitors. These drugs function by inhibiting the “reuptake” of serotonin and norepinephrine, two neurotransmitters in the brain responsible for controlling mood. SNRIs like Effexor are very similar to SSRIs, or selective serotonin reuptake inhibitors, which act upon serotonin alone to relieve depression and improve certain mood disorders. The active ingredient in Effexor is venlafaxine, and the drug was approved by the FDA in 1993 for the treatment of major depressive disorder, social anxiety disorder and generalized anxiety disorder. Effexor is currently manufactured by Wyeth Pharmaceuticals, a division of pharmaceutical giant, Pfizer, Inc.
Although antidepressant medications like Effexor have become increasingly popular in recent years, these drugs have also become the subject of significant scrutiny as the safety of antidepressants, especially in treating pregnant women, has been re-evaluated. According to a number of antidepressant birth defect studies, infants born to women who take certain antidepressant drugs during pregnancy may have a significantly increased risk of suffering from one or more serious birth defects, including anal atresia.
Anal atresia, also known as imperforate anus, is a congenital birth defect characterized by a missing or blocked opening to the anus. Anal atresia is caused by a malformation which occurs during the early stages of fetal development and results in an absent or narrowed anal opening, preventing stool from leaving the body properly. In some cases of this defect, the rectum may end in a blind pouch that fails to connect to the colon, or it may have openings to the bladder, urethra, the scrotum or base of the penis in boys, or the vagina in girls. Common signs of anal atresia include a swollen abdomen, failure to pass stool within 24-48 hours after birth, and stool passing out of the vagina, urethra, scrotum, or base of the penis.
The only way to correct anal atresia and restore the function of the internal structures is for the child to undergo reconstructive surgery. In some instances, the rectum may connect with other organs, in which case these organs would need to be repaired as well. Even with treatment, some children may still suffer from bowel incontinence, constipation and intestinal blockage. Because many infants with anal atresia are born with additional birth defects, particularly those affecting the genitals, spine and urinary tract, all children with this defect should be tested for other malformations.
In 2006, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between the use of SSRI antidepressants during pregnancy and PPHN. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening heart and lung condition in which a child’s circulation continues to bypass the lungs after birth. This FDA notice came on the heels of a study published in the New England Journal of Medicine earlier that year. According to researchers involved in this study, women who took certain antidepressants after the twentieth week of pregnancy were an alarming six times more likely to give birth to infants with PPHN. The FDA has also since required all SSRI sponsors to update their drugs’ warning labels to include potential pregnancy precautions, namely PPHN.
In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of antidepressants on infants exposed to the drugs during pregnancy. According to the first study, infants born to women who took certain antidepressant drugs during the first trimester of pregnancy were nearly twice as likely to develop birth defects like anal atresia, limb defects and club foot. Researchers also found a connection between these drugs and cleft palate, neural tube birth defects and cleft lip. The second NEJM study indicated that infants exposed to certain antidepressants in utero were more than twice as likely to be born with catastrophic birth defects like anencephaly, craniosynostosis and omphalocele.
The American Journal of Nursing published a study in 2010 which indicated a potential connection between the use of certain antidepressants during pregnancy and heart defects, particularly atrial septal defects and ventricular septal defects. According to researchers, the prevalence of septal heart defects among infants exposed to these drugs was 0.9%, compared to the prevalence among unexposed infants, which was 0.5%.
The FDA has labeled Effexor a pregnancy category C medication, a category reserved for drugs with the potential to cause serious harm to a fetus when taken during pregnancy. If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your physician immediately. You should never suddenly discontinue use of a prescription medication, but with your doctor’s help, you may be able to find an alternative to Effexor for treating your medical condition.
Drug manufacturing companies like Wyeth are responsible for the safety of their medications even after they enter the market, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies are actually aware of the harmful nature of their products and intentionally conceal this information in order to expedite the FDA approval process and to ensure their product is well-received by the public. This misleading practice puts millions of consumers unknowingly at risk of suffering severe injury, illness and even death, which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. If you or a loved one has suffered from anal atresia and you believe Effexor to be the cause, contact a qualified Effexor attorney as soon as possible.
Birth defects like anal atresia are likely to require extensive medical treatment, which can result in costly medical expenses. Only by filing an Effexor lawsuit against Wyeth Pharmaceuticals can victims of alleged Effexor birth defects seek financial compensation for their injuries, medical expenses and pain and suffering. Defective drug lawsuits also bring much-needed attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market. Effexor lawyers are well-versed in defective drug litigation and can help you protect your rights, stand up to big drug companies, and collect the compensation you deserve.