Cleft Palate - Consumer Justice Foundation

Cleft Palate

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Effexor and Cleft Palate

Antidepressants were originally designed as a primary treatment for individuals suffering from depression, although the drugs have been prescribed for additional purposes since the first of the drugs entered the market. The two most common types of antidepressant medications are SSRIs and SNRIs, both of which have proven largely successful in treating depression and other mood disorders. SNRIs, or serotonin-norepinephrine reuptake inhibitors, function by inhibiting the “reuptake” of serotonin and norepinephrine, two neurotransmitters in the brain responsible for controlling mood. These drugs were developed more recently than SSRIs, or selective serotoinin reuptake inhibitors, which have a similar function but act upon serotonin alone.

Effexor (venlafaxine) is an SNRI antidepressant which was approved by the FDA in 1993 and has since been prescribed for the treatment of major depressive disorder, generalized anxiety disorder, and social anxiety disorder. Although these are its only approved uses, the drug is also often prescribed for off-label purposes as well, including the treatment of diabetic neuropathy and panic disorder. Effexor is currently manufactured by Wyeth Pharmaceuticals, a division of Pfizer, Inc., and has become one of the most widely prescribed antidepressant drugs on the U.S. market. Unfortunately, recent research has indicated that women who take certain antidepressant drugs during pregnancy may significantly increase their risk of giving birth to infants with one or more serious birth defects, including cleft palate.

Cleft Palate Described

Cleft palate is a craniofacial birth defect characterized by an opening in the palate, or roof of the mouth. This malformation is caused by a lack of cells present in the palate area as the structure is forming during fetal development, and can vary in severity from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth. Because of the opening in the roof of the mouth, children with cleft palate may struggle with feeding difficulties caused by food and liquid passing from the mouth back through the nose. Infants with this defect are also more prone to having fluid build up in their ears, which can result in recurring ear infections and hearing loss. Other complications associated with cleft palate include delays in speech and language development and dental issues like missing or misaligned teeth.

Cleft Palate Treatment and Complications

There are temporary treatment options available for children with cleft palate, including the use of baby bottles specially designed to keep fluid flowing downward, and the implantation of a temporary palate in order to help the child eat properly. However, the only way to permanently repair a cleft palate and correct the issues associated with this malformation is for the child to undergo reconstructive surgery. In many cases, children with cleft palate require multiple surgeries, the first of which is typically performed during the first year of the child’s life.

Potential Effexor Birth Defects and FDA Warnings

In 2006, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between the use of SSRI antidepressant drugs during pregnancy and the development of PPHN among infants exposed to the drugs in utero. PPHN, or persistent pulmonary hypertension of the newborn, is a serious birth defect in which a child’s circulation continues to bypass the lungs after birth. This FDA decision came on the heels of a 2006 study published by the New England Journal of Medicine in which researchers found a six-times increased risk of PPHN among infants exposed to certain antidepressants during pregnancy, compared to unexposed infants. The FDA has since required all sponsors of SSRI medications to update their drugs’ warning labels to include potential pregnancy precautions, namely PPHN. Although the majority of antidepressant birth defect studies have focused primarily on SSRI antidepressants, the similarity between these and SNRI drugs may allow experts to examine the results of SSRI studies in order to evaluate the potentially harmful nature of SNRIs like Effexor.

A number of other antidepressant birth defect studies have been published in recent years, raising concerns about the safety of these medications, especially in treating pregnant women. In 2007, the NEJM published two additional studies in an attempt to examine the adverse effects of antidepressants on infants exposed to the drugs during pregnancy. The first study indicated that women who took certain antidepressants during the first trimester of pregnancy were nearly twice as likely to give birth to infants with birth defects like club foot, anal atresia and limb defects. Researchers also found a connection between these antidepressant drugs and cleft lip, cleft palate, and neural tube birth defects. The second study suggested that infants whose mothers took certain antidepressants while pregnant were more than twice as likely to be born with devastating birth defects like anencephaly, craniosynostosis and omphalocele. Another study published in 2010 in the American Journal of Nursing determined that fetal exposure to certain antidepressants was associated with an increased risk of heart defects, namely atrial and ventricular septal defects.

Effexor Use While Pregnant

The FDA has labeled Effexor a pregnancy category C medication, a category reserved for drugs with the potential to cause serious harm to a human fetus when taken during pregnancy. The FDA has also advised healthcare professionals to avoid prescribing category C medications like Effexor to pregnant women unless the possible benefits of the drug outweigh the potential risks to the fetus. If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your physician as soon as possible. It may be dangerous to suddenly discontinue use of a prescription medication, but with your doctor’s help, you may be able to find a safer way to treat your condition.

Contact an Effexor Attorney for Help

Birth defects like cleft palate have the potential to cause serious problems for an affected child, as well as costly medical expenses for the child’s family. If you or a loved one has suffered from a cleft palate and you believe Effexor to be the cause contact an Effexor attorney, as you may be entitled to reimbursement for these medical expenses, as well as the pain and suffering endured by you and your family. By filing an Effexor lawsuit or joining a potential Effexor class action lawsuit, victims of alleged Effexor birth defects can collect the financial compensation they deserve, while also bringing public attention to the importance of safe medications on the market.

You are not responsible for any injuries or medical bills resulting from the proper use of a potentially dangerous drug. Drug manufacturing companies like Wyeth Pharmaceuticals are expected to produce safe and effective medications, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies operate in their own best interest and deny liability for dangerous drug injuries in order to avoid negative consequences such as a drug recall. Only by hiring a qualified Effexor attorney to represent your case can you protect your rights and fight against the allegedly deceptive practices of big drug companies.

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