Zoloft is the brand name for an antidepressant called sertraline. It was first developed, tested, and released by Pfizer in 1991. The patent has since run out and the product is available as a generic drug as well as Zoloft. By 2013 sertraline had become the most prescribed antidepressant in the country and the second most prescribed of all psychiatric drugs.
Sertraline is approved to treat depression and certain other conditions, and while it has helped many people to feel better, it also causes side effects. Some of these are mild and well-tolerated by many patients, but others can be serious and may even lead to death. Pfizer may not have been completely up front about all of these side effects and now the company faces lawsuits over them. Many of these lawsuits focus on the birth defects it has caused in the children of women who used the drug while pregnant.
Zoloft and SSRIs
Sertraline is a compound that has been around since the 1970s when it was discovered by a Pfizer chemist. It took a long time, though, to develop it into a medication that would be effective in treating depression. The U.S. Food and Drug Administration (FDA) approved Zoloft in 1991. The initial approval was for treating major depression in adult patients.
Zoloft was immediately popular and by 2002 the FDA had expanded its approval to include treatment of anxiety disorders in adults. It can be used to treat obsessive compulsive disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, and post-traumatic stress disorder. Zoloft is also approved for treating obsessive compulsive disorder in children six and older and for premenstrual dysphoric disorder in adults.
Sertraline works by affecting serotonin levels in the brain. Serotonin is a brain chemical, known as a neurotransmitter that plays a role in mood. Zoloft is known as a selective serotonin reuptake inhibitor, or SSRI. It blocks the reuptake of serotonin, resulting in more of this chemical in the brain. Other SSRIs include Prozac, Paxil, Lexapro, and Celexa.
Common Side Effects
Zoloft, like other antidepressants, can take weeks to start working. Some patients may experience side effects, but many of these will disappear as the positive effects of the drug start to kick in. Most commonly reported are appetite loss, weight loss, dry mouth, dizziness, bloating, gas, vomiting, diarrhea, nausea, constipation, tiredness, headaches, nervousness, sexual dysfunction, sore throat, shaking, tingling and pain in the hands and feet, and excessive sweating.
Most of the lawsuits Pfizer has faced over Zoloft are related to the side effects that can occur in the children born to women who used it during pregnancy. Depression during pregnancy can be very serious for the mother and child and women need some type of treatment, but antidepressants are proving to be risky. Women and their doctors have to weigh the benefits of treatment with the risks of birth defects, complications, and developmental disorders.
All SSRIs have been implicated in birth defects to some extent, but sertraline may pose the biggest risk. Studies have found that among women giving birth to children with defects, the most commonly used antidepressant was Zoloft. Although this may be partially explained by the popularity of the drug, it may also lead to the conclusion that sertraline causes more birth defects than other SSRIs.
In addition to birth defects, which include heart, gastrointestinal, spinal, skull and facial defects, Zoloft may also cause a dangerous complication called persistent pulmonary hypertension of the newborn, or PPHN. This condition occurs when an infant struggles to transition to breathing air and it can be fatal if not treated immediately.
Most recently, Zoloft has been found to possibly be connected to autism spectrum disorders. Studies have found that SSRIs may increase the risk of a child being diagnosed with autism by as much as 200 percent. The risk seems to be greatest during the second and third trimesters of pregnancy. All antidepressants were implicated in the risk, but SSRIs like Zoloft were found to cause the greatest risk. More than one study has come to this conclusion.
While birth defects have triggered the most lawsuits over Zoloft, there are other potentially serious side effects. One of these is called serotonin syndrome and it happens when the brain is flooded with serotonin. For most people taking Zoloft as directed, this occurrence is very rare. The risk goes up with abuse of an SSRI or combining it with other antidepressants or medications that affect serotonin.
It is possible that serotonin syndrome will occur when the dosage is increased for a patient. For this reason, all patients need to be aware of the signs so they can seek treatment right away. Symptoms of serotonin syndrome include a fast heartbeat, nausea, vomiting, diarrhea, agitation, hallucinations, rigid muscles, and poor coordination.
All SSRIs have the potential to cause withdrawal if someone stops taking them suddenly. Zoloft is not considered addictive, but the symptoms caused by sudden discontinuation mimic those seen in drug addicts going through withdrawal. These include nausea, insomnia, agitation, anxiety, headaches, and vomiting. Withdrawal severity varies depending on the individual, but can become serious. No one should stop using Zoloft or any antidepressant without a doctor’s guidance.
The risk of suicide as a side effect of Zoloft is serious enough that the FDA requires it to be included on package labeling as a black box warning. The warning states that antidepressants like Zoloft increase the risk of experiencing suicidal thoughts and engaging in suicidal actions for people 24 years old and younger. It is because of this that Zoloft is not indicated for children for most uses. The only approved use in children is for obsessive compulsive disorder.
Doctors may use professional discretion to prescribe the drug to a child or teen, but this is not typically done unless that child’s illness is severe and has not responded to other kinds of treatments. The FDA did not issue a warning about the risk of suicide until 2007. Zoloft had been on the market for more than a decade and although it was not commonly used in children, many were put at risk because they were not aware of the dangers.
Pfizer is facing hundreds of lawsuits, now consolidated in a multi district legislation, over Zoloft because of side effects, mostly those related to birth defects and complications. Plaintiffs felt they were not really warned of all the risks before choosing to use Zoloft during pregnancy. As more information comes to light about the connection to autism, even more lawsuits may begin to seek compensation for families affected by this developmental disorder.