Cleft Lip - Consumer Justice Foundation

Cleft Lip

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Effexor and Cleft Lip

Effexor is one of a class of prescription antidepressant medications known as 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. These drugs differ only slightly from their counterparts, called selective serotonin reuptake inhibitors (SSRIs), which act upon serotonin only in order to relieve depression and improve certain mood disorders. Effexor is currently manufactured by Wyeth Pharmaceuticals, a division of Pfizer, Inc., and was approved by the FDA in 1993 for the treatment of major depressive disorder, generalized anxiety disorder and social anxiety disorder. Effexor (venlafaxine) was the sixth most commonly prescribed antidepressant on the market in 2007, with 17.2 million prescriptions filled.

Regardless of the popularity of antidepressant medications, the safety of these drugs has become the subject of significant scrutiny in recent years as a number of studies have established a possible connection between the use of certain antidepressants during pregnancy and the development of major birth defects among infants. Unfortunately, many of these birth defects, including cleft lip, are established during the first trimester of pregnancy, which means a woman taking these drugs may cause considerable harm to her unborn child before she is even aware she is pregnant. Because nearly half of all pregnancies are unplanned, all women of childbearing age taking these potentially dangerous drugs may be at risk of giving birth to children with one or more major birth defects, including cleft lip.

Cleft Lip Signs and Symptoms

Cleft lip is a congenital birth defect which disrupts the formation of a child’s upper lip during fetal development. This malformation occurs when there aren’t enough cells in the upper lip area as the structure is fusing together in utero, resulting in an opening in the lip. The degree of a cleft lip can range from a small notch in the lip to a large fissure which may extend up through the nose, in severe instances.

Cleft Lip Treatment and Complications

Treatment for a cleft lip typically involves surgery in order to reconstruct the lip and restore the function and appearance of the child’s mouth. With surgery, children born with a cleft lip typically make a full recovery. However, without treatment, the child may suffer from serious complications as a result of the defect, including feeding difficulties, as food and liquid may pass from the mouth back through the nose; chronic ear infections and hearing loss due to a tendency for fluid to build up in the ears; dental issues like missing or malformed teeth; and speech and language delay.

Alleged Effexor Birth Defects

There have been a number of birth defect studies conducted in recent years in which researchers have sought to examine the adverse effects of antidepressant use during pregnancy on infants exposed to the drugs in utero. Although these studies have focused primarily on SSRI antidepressant drugs in particular, the similarity between these and SNRIs like Effexor may allow experts to use the results of these studies to evaluate the potentially harmful nature of SNRIs. According to a 2006 study published in the New England Journal of Medicine, there may be a significant connection between women who take certain antidepressants while pregnant and the development of PPHN among infants. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening birth defect in which a child’s body fails to adapt to breathing outside the womb and the circulation continues to bypass the lungs after birth. Researchers involved in this study indicated that infants whose mothers took certain antidepressant drugs after the twentieth week of pregnancy were an alarming six times more likely to develop PPHN than infants whose mothers took no antidepressants while pregnant.

Several other antidepressant birth defect studies have been performed in recent years. In 2007, the NEJM published two additional studies in which researchers found that infants exposed to certain antidepressant medications in utero were nearly twice as likely to be born with birth defects like anal atresia, limb defects, and club foot, and more than twice as likely to develop severe birth defects like craniosynostosis, anencephaly, and omphalocele. A possible connection was also found between fetal exposure to certain antidepressants and malformations like neural tube birth defects, cleft palate and cleft lip. The American Journal of Nursing published a study in 2010 in which researchers indicated an increased risk of heart defects, particularly atrial and ventricular septal defects, among infants born to women who took certain antidepressants while pregnant.

Effexor Use During Pregnancy

The FDA has classified Effexor as a pregnancy category C medication, which means the drug has the potential to cause serious harm to a human fetus when taken during pregnancy. In response to the 2006 NEJM study, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRI antidepressants in utero. The FDA has also required all sponsors of SSRIs to update their drug warning labels to include potential pregnancy precautions, namely PPHN.

If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your physician as soon as possible to discuss alternative treatment options. You should never suddenly stop taking a prescription medication as this may cause further harm to you or your child. In the meantime, the FDA has advised physicians to avoid prescribing Effexor to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus.

Contact an Effexor Attorney for Help

Although most cases of cleft lip can be treated successfully, some affected infants may require multiple surgeries followed by long term medical care in order to monitor their development and prevent further complications. Proper care for cleft lip and other birth defects may result in exorbitant medical expenses, which can be an overwhelming burden for families already emotionally compromised by a birth defect diagnosis. If you or a loved one has suffered from a cleft lip which you believe to be associated with the use of Effexor, contact an Effexor attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing an Effexor lawsuit against Wyeth Pharmaceuticals (Pfizer).

You are not at fault for any injuries caused by the proper use of a dangerous drug, and you should not be held responsible for the resulting consequences. Pharmaceutical companies like Wyeth are expected to manufacture and market safe and effective drugs, and are also expected to alert the public of any potential dangers associated with their products. Unfortunately, some drug manufacturing companies intentionally conceal this information in order protect themselves from a drug recall or other negative outcomes. This deceptive practice puts millions of consumers at risk of suffering life-altering and even fatal injuries or illnesses, which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. Defective drug litigation can be a complicated process, but by hiring an experienced Effexor lawyer, victims of alleged Effexor birth defects can feel confident that their case is in good hands.

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