Paxil - Cleft Palate - Consumer Justice Foundation

Paxil – Cleft Palate

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Paxil and Cleft Palate Birth Defects

Paxil is one of a group of prescription antidepressant medications known as SSRIs, or selective serotonin reuptake inhibitors. Paxil and other SSRI drugs work by restoring the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Paxil (paroxetine) was approved by the FDA in 1992 for the treatment of major depressive disorder, in 1996 for major panic disorder and obsessive-compulsive disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for generalized anxiety disorder. Paxil is currently manufactured by pharmaceutical company, GlaxoSmithKline. Despite the popularity of Paxil and other SSRI antidepressants in treating depression and a number of other disorders, recent research has suggested that these drugs may not be appropriate in the treatment of pregnant women. According to a number of studies, infants whose mothers take SSRIs like Paxil during pregnancy may have a significantly increased risk of being born with serious birth defects like cleft palate. Unfortunately, the Journal of the American Medical Association estimates that over 80,000 pregnant women are prescribed SSRI antidepressants in the United States in any given year.

Cleft Palate Described

Cleft palate is a craniofacial birth defect involving a malformation of the palate, or roof of the mouth in utero. Under normal circumstances, the palate is fully formed during the early stages of fetal development. However, when there isn’t enough tissue in the palate area as this process is taking place, a cleft palate may occur. A cleft palate can affect the bony front portion or the soft back portion of the mouth, and can range in severity from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth.

Cleft Palate Treatment and Complications

There are temporary treatment options available for infants born with a cleft palate. For example, there are baby bottles specially designed to keep fluids flowing downward, and there are also artificial palates which can be implanted in order to help a child eat properly. However, the only way to permanently correct the defect is for the child to undergo oral surgery. Without treatment, affected children may suffer from significant complications associated with the defect, including feeding difficulties, recurring ear infections, hearing loss, speech and language delay, and missing or misaligned teeth.

Alleged Paxil Birth Defects and FDA Warnings

In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of congenital birth defects, particularly heart defects, among infants exposed to paroxetine (Paxil) in utero. The advisory also elevated the pregnancy category of Paxil from C to D. This FDA decision was based upon information provided by two unpublished epidemiology studies which suggested that fetal exposure to Paxil may result in adverse side effects. The first study collected data from a Swedish national pregnancy registry and indicated that infants born to women who took Paxil during early pregnancy were nearly twice as likely to develop a heart defect, compared to the entire registry population. The second study was performed in the United States and determined that infants whose mothers took Paxil during the first trimester of pregnancy had a 1.8-fold increased risk of congenital birth defects and a 1.5-fold increased risk of heart defects, compared to infants whose mothers took other antidepressants while pregnant.

In 2006, the FDA issued another public health advisory after reviewing a revealing New England Journal of Medicine study. According to this study, infants exposed to SSRI antidepressants like Paxil during the third trimester of pregnancy were an alarming six times more likely to develop PPHN, compared to unexposed infants. PPHN, or persistent pulmonary hypertension of the newborn, is a serious heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. The NEJM published two additional studies in 2007 in which researchers sought to examine the adverse effects of SSRI antidepressants on infants exposed to the drugs in utero. According to the first study, infants whose mothers took an SSRI like Paxil during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like anal atresia, club foot and limb defects. Researchers also found a connection between these drugs and cleft palate, cleft lip and neural tube birth defects. The second study indicated that infants born to women who took an SSRI like Paxil while pregnant were more than twice as likely to develop devastating birth defects like anencephaly, craniosynostosis and omphalocele.

Paxil Use and Pregnancy

The pregnancy category of Paxil has been elevated by the FDA from C to D, which means there is positive human evidence illustrating the drug’s potential to cause significant harm to a fetus when taken during pregnancy. If you are currently taking Paxil 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.

A Paxil Attorney Can Help

In most cases, cleft palate can be treated surgically with few problems. However, some children may require multiple surgeries, and others may need long-term care after surgery in order to monitor development and prevent further complications. Unfortunately, seeking proper care for birth defects like cleft palate can result in costly medical expenses, which may be an overwhelming financial burden for some families. If you or a loved one has suffered from a cleft palate which you believe to be associated with the use of Paxil, contact a Paxil attorney immediately. You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Paxil lawsuit against GlaxoSmithKline. Defective drug lawsuits also bring much-needed attention to the importance of having safe medications on the market.

Victims of serious injuries resulting from the proper use of a dangerous drug are not at fault, and should not be held responsible for the resulting consequences. Drug manufacturing companies should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally deny liability for dangerous drug injuries in order to avoid a drug recall or other negative consequences. Not only does this deceptive practice prevent consumers from collecting the compensation they deserve, but it also puts millions of other consumers unknowingly at risk of suffering severe injury, illness or even death, just by taking their prescription medications. The only way to protect your rights and stand up to big drug companies is to hire an experienced Paxil lawyer to represent your case.

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