Cleft Lip - Consumer Justice Foundation

Cleft Lip

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Zoloft and Cleft Lip Birth Defects

Zoloft belongs to a class of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors, which function by restoring the balance of serotonin in the brain, a neurotransmitter responsible for controlling mood. By doing so, SSRIs can effectively relieve depression and improve certain mood disorders. The active ingredient in Zoloft is sertraline, and the drug was originally approved by the FDA in 1991. Since its introduction, Zoloft has been approved for the treatment of major depression, obsessive-compulsive disorder, premenstrual dysphoric disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder. Zoloft is currently manufactured by Pfizer Inc. and, as of 2007, was the most frequently prescribed antidepressant on the market, with 29.7 million prescriptions filled.

Despite the popularity of the drug in treating depression and other disorders, Zoloft and other SSRI antidepressants have been the subject of significant scrutiny in recent years because of their potential connection to serious birth defects. According to a number of studies, infants whose mothers take SSRIs while pregnant may have a significantly increased risk of developing major birth defects, including cleft lip. Unfortunately, the Journal of the American Medical Association has estimated that more than 80,000 pregnant women are prescribed SSRI antidepressants like Zoloft in the United States in any given year.

Cleft Lip Signs and Symptoms

Cleft lip is a birth defect caused by the malformation of the upper lip as the fetus is developing in utero. This defect occurs when there is a lack of tissue in the lip area as the structure is forming during the early stages of pregnancy, preventing the lip from fusing together completely. Cleft lip is characterized by a vertical fissure in one or both sides of the upper lip, and can vary in severity from a small notch in the lip to a severe crevice which may extend up through the nose.

Cleft Lip Treatment and Complications

It is important to seek proper medical treatment for children with cleft lip, as this defect can lead to significant complications if left untreated. Because of the opening between the mouth and nose, food and liquid may pass from the mouth back through the nose, causing severe feeding difficulties for an affected infant. Children with cleft lip are also more prone to having fluid build up in their ears, commonly resulting in frequent ear infections and sometimes even hearing loss. Other complications associated with this defect include speech and language delay and dental issues like missing or malformed teeth. In order to permanently repair a cleft lip and alleviate the symptoms associated with the condition, affected children typically undergo oral surgery. In some cases, the child may require multiple surgeries, and may also benefit from long term medical care in order to monitor development and prevent further complications.

Zoloft Birth Defect Studies and FDA Warnings

In 2006, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRI antidepressants like Zoloft in utero. The FDA also required all SSRI sponsors to change drug prescribing information to include the potential risk for PPHN. These decisions were made after the FDA reviewed the results of a study published in the New England Journal of Medicine earlier that year. According to the study, women who took an SSRI antidepressant like Zoloft after the twentieth week of pregnancy were a shocking six times more likely to give birth to an infant with PPHN, compared to women who took no antidepressants while pregnant. The report indicated that up to twelve out of 1,000 infants exposed to an SSRI were born with PPHN, compared to the expected rate among the general population, which is one to two out of 1,000 infants.

In 2007, the NEJM published two additional studies, the first of which indicated that infants exposed to SSRIs like Zoloft during the first trimester of pregnancy were nearly twice as likely to develop birth defects like limb defects, anal atresia and club foot. Researchers also found a potential link between SSRIs and cleft palate, cleft lip and neural tube birth defects. According to the second study, infants whose mothers took an SSRI while pregnant were more than twice as likely to be born with catastrophic birth defects like anencephaly, craniosynostosis and omphalocele.

Another study was published in the American Journal of Nursing in 2010, which determined that infants born to women who took an SSRI like Zoloft during the first trimester of pregnancy were nearly twice as likely to develop serious heart defects, namely atrial and ventricular septal defects. According to the report, the prevalence of septal heart defects among infants exposed to an SSRI in utero was 0.9%, compared to the prevalence among unexposed infants, which was 0.5%.

Zoloft Use During Pregnancy

Zoloft has been classified by the FDA as a pregnancy category C medication, which means the drug has the potential to cause harm to a human fetus when taken during pregnancy. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician as soon as possible. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you or your child. However, with the help of your doctor, you may be able to find a safer way to treat your medical condition.

Contact a Zoloft Attorney for Help

Although children born with a cleft lip typically make a full recovery after surgery, proper medical care is likely to result in exorbitant medical expenses, which can be a significant financial burden for the child’s family. If you or a loved one has suffered from a cleft lip, which you believe to be associated with the use of Zoloft, contact a Zoloft attorney immediately. You may be entitled to reimbursement for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Zoloft lawsuit against Pfizer. Besides seeking financial compensation, defective drug lawsuits also bring much-needed attention to the hazardous nature of certain drugs, potentially preventing injuries and death in the future.

While most consumers understand that no drug is 100% safe, they do expect to be adequately notified of any potential hazards associated with their prescription drugs. Drug manufacturing companies are responsible for providing accurate and prompt drug information, so that consumers can make an educated decision about the use of their prescription medications. Unfortunately, some drug companies intentionally conceal dangerous drug information in order to prevent negative consequences, such as a drug recall. This deceptive practice puts millions of consumers unknowingly at risk of suffering serious injury, illness and even death, which could have been prevented had the drug company taken the appropriate steps to avoid unnecessary harm. Defective drug litigation can be a complex process, but with the help of an experienced Zoloft lawyer, you can protect your rights and collect the compensation you deserve.

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