As an antidepressant, Zoloft has brought relief for many people struggling with negative thoughts and feelings. First introduced by Pfizer in 1991, Zoloft is now available as a generic drug as well, called sertraline. Zoloft has been a big seller for Pfizer. In 2013 it was the most prescribed antidepressant and it was also the second most popular of all psychiatric medications.

The downside to taking Zoloft is that it can cause a number of side effects, ranging from mild to severe. Some of these side effects and risks were not immediately disclosed by Pfizer, which means the company is now facing expensive lawsuits. One of the reasons people are suing Pfizer over Zoloft is because of the possible increase in the risk of birth defects when taken during pregnancy. If you had a child born with defects because of Zoloft, you can join the other parents suing for monetary compensation.

What is Zoloft?

Zoloft is the brand name for the generic antidepressant called sertraline. Sertraline was first discovered by a Pfizer chemist back in the 1970s. It took a while to develop a drug that would be effective in treating depression and it wasn’t until 1991 that the U.S. Food and Drug Administration (FDA) approved sertraline and Pfizer began marketing and selling it as Zoloft.

Zoloft’s popularity took off immediately and it was considered to be both safe and effective for treating depression in adults. In 2002 the FDA approved its use in children between the ages of six and 18, but only for a specific type of anxiety disorder called obsessive compulsive disorder. In 2005, the FDA required that Zoloft carry a black box warning, the type of label warning reserved for the most serious potential side effects of a medication.

Uses for Zoloft

Zoloft was first approved for the treatment of major depression in adults only. It is also now approved to treat a number of types of anxiety disorders in adults. These include obsessive compulsive disorder, panic disorder, social anxiety disorder, and post-traumatic stress disorder. It can also be used to treat premenstrual dysphoric disorder, which is characterized by mood swings, irritability, and physical symptoms.

Sertraline is not indicated for use in children with depression, only for those over the age of six with obsessive compulsive disorder. Off-label, doctors may prescribe Zoloft for adults with headaches or certain sexual dysfunctions.

How it Works

Zoloft belongs to a class of medications called selective serotonin reuptake inhibitors, or SSRIs. These drugs are indicated to treat depression and anxiety and work by acting on a brain chemical called serotonin. Serotonin is a neurotransmitter that moves between neurons in the brain to send messages. It has been implicated in mood, with low levels of serotonin causing depression and anxiety.

Sertraline and other SSRIs work in the brain by blocking the reuptake of serotonin. Neurons take up serotonin when a signal in the brain tells them there is too much of it. This may malfunction in someone with depression, leaving that person with a depletion of serotonin. By blocking that reuptake, SSRIs increase serotonin levels and this improves mood for many people.

Side Effects

Most of the side effects experienced with Zoloft are mild and many will disappear in time. SSRIs take time to take effect in the brain, sometimes a month or more, so the body requires time to adjust to the new medication. Some of the side effects experienced include constipation, nausea, vomiting, diarrhea, gas, bloating, dry mouth, loss of appetite and weight, dizziness, tiredness, drowsiness, headaches, nervousness, shaking, a sore throat, sexual dysfunction, sweating, and pain or tingling in the feet or hands.

Suicide – Black Box Warning

Zoloft carries a black box warning on its label, which the FDA required beginning in 2007. Based on evidence from adverse event reports and studies, the FDA concluded that sertraline and other antidepressants carry a serious and potentially fatal risk for young people. For people aged 24 and younger, taking these drugs may cause suicidal thoughts and increase the likelihood of self-harm or suicidal actions.

Although the drug is not indicated or approved for treating depression in children, doctors may prescribe it when nothing else works. For a child that gets no relief from other strategies, the use of an antidepressant may be the last ditch effort. The dangers are serious, though, and all children using Zoloft should be carefully monitored for signs of suicidal thoughts like mood swings, or sudden changes in feelings, behaviors, or actions.

Serotonin Syndrome

Another serious risk associated with Zoloft and other SSRIs is something called serotonin syndrome. It occurs when the brain is flooded with serotonin. This can happen with abuse of an SSRI, but also when the dosage is increased. Anyone taking SSRIs should watch out for signs of serotonin syndrome, which include hallucinations, sweating and fever, a racing heartbeat, agitation, poor coordination, twitching muscles, rigid muscles, and nausea, vomiting, or diarrhea. If you see any of these signs in yourself or someone else taking an SSRI, seek medical attention right away.

Pregnancy Risks

Serotonin syndrome and suicidal thoughts can be very serious, but the reason for current lawsuits against Pfizer and Zoloft are mostly related to birth defects and autism in the children of women who took the drug during pregnancy. Other antidepressants have also been implicated in these defects, but sertraline may pose a big risk.

In one study of adverse event reports, researchers found that among those reported birth defects, most were from mothers who had taken sertraline. The defects reported included heart defects and gastrointestinal defects. SSRIs can also cause a condition in infants called persistent pulmonary hypertension of the newborn, which can be fatal.

Most recently, studies have linked use of Zoloft during pregnancy with an increased risk of autism. Zoloft and other SSRIs have been found to increase that risk by around 200 percent. The risk was greatest when women took the medication during the second and third trimesters. Autism is a developmental disorder that can have lasting and serious effects on a child.

Lawsuits

The presence of birth defects in some children born to mothers who took Zoloft has spurred a number of lawsuits against Pfizer. The claim is that the company did not adequately warn patients and doctors of the risks. Several suits have been consolidated and there is still time to make your case against Pfizer if you experienced any of the negative side effects of the antidepressant. Whether you have a child with autism, a child that was born with a birth defect or you had a child die of suicide while taking Zoloft, there are many reasons why Pfizer may be forced to pay up.