Introduced in the 1990s, Zoloft quickly became one of the leading antidepressants prescribed by doctors all over the U.S. because of its breakthrough way of regulating serotonin levels in clinically depressed patients, as well as those with obsessive-compulsive disorder, post-traumatic stress disorder, and anxiety. Selective serotonin re-uptake inhibitors (SSRIs) antidepressants were thought to have fewer side effects than their predecessors, and over time, they were increasingly prescribed not only by psychiatrists, but also by primary care physicians. The manufacturers of the drug marketed them directly toward consumers with very positive advertising, leading millions who suffered from mild or situational depression to ask their family doctor for Zoloft. Sales grew steadily, and at its most profitable, Zoloft grossed more than 2.6 billion in 2005 with more than 30 million prescriptions written.
Since its approval by the FDA, however, side effects have begun to appear in the lives of many who have used the drug. Suicidal thoughts and severe withdrawal were two of the more significant side effects noted, as well as heart problems. Some users have also stated that while the drug failed to provide the benefits of treatment as advertised, they still experienced the negative side effects.
Due to an increased risk of suicide in younger patients who were prescribed an SSRI for depression, the FDA advisory panels suggested new, expanded warning labels on antidepressants to advise physicians to monitor young patients for signs of worsening depression or suicidal ideation, especially early in therapy or when dosages changed. The panel recommendations followed emotional testimony from parents of children and teenagers who had attempted suicide or had taken their lives after starting antidepressant therapy. Researchers at Columbia University confirmed that 10 percent of adolescents suffer from depression, and that in 2001, 1,883 children between the ages of 10-19 killed themselves. A British study also found an increase in suicide attempts among children using antidepressants versus those who were given sugar pills.
In 2013, Pfizer Inc., the maker of Zoloft, was sued by a woman who claimed that the medication provided no benefit and that patients who used it should be reimbursed for the money they spent purchasing the drug. Pfizer disputed the claim, but the plaintiff’s attorney argued that the FDA should not have approved Zoloft because the manufacturer withheld information from consumers that some clinical studies found the drug to be about as effective as a placebo. In addition to consumer fraud, the lawsuit alleged that Pfizer paid physicians to recommend Zoloft to colleagues or to be credited for authoring positive medical journal articles which were actually prepared by the company
Zoloft has been linked to birth defects when used by pregnant women. Many expectant mothers were led to believe that Zoloft was safe to take during pregnancy, when in fact, children born to these mothers have suffered a multitude of issues as a direct result of SSRI use during pregnancy. Lung defects and deformities, respiratory problems, clubbed feet, cleft lip, cleft palate, developmental delays, persistent pulmonary hypertension, ventricular outflow defects, hypoplastic left heart syndrome, congenital heart lesions and anomalies, Down’s syndrome, undescended testes in males, blindness, hernia, organs protruding from the abdomen, heart defects, skull defects, brain and spinal cord defects, premature birth, withdrawal, miscarriage—the list is extensive. Yet, the multi-billion dollar drug company Pfizer is accused of continuing to promote antidepressants such as Zoloft to pregnant women even though studies confirm such birth defects are caused by SSRIs.
According to recent studies, women who took Zoloft while pregnant were 200 percent more likely to have a child diagnosed with autism. Persistent pulmonary hypertension of the newborn (PPHN), once thought of as a rare condition, was being diagnosed in infants of mothers who were prescribed Zoloft during pregnancy. PPHN can be fatal and is certainly hard for new parents to endure emotionally as the infants will appear blue, have rapid respiratory and heart rate, and may experience swelling of the feet and hands. These infants and their parents will spend much of their future in hospitals undergoing expensive and often painful medical procedures. They will spend their lives on medication after medication, with side effect after side effect. Women who were seeking a better quality of life free of depression have ended up in even worse situations, and so have their children.
Although researchers cannot pinpoint exactly why antidepressants increase the mortality rate for heart disease patients, studies have confirmed the link between SSRI use and an increased risk of death among patients with coronary artery disease. Over the course of three years, Duke University researchers compared survival rates between patients who were using antidepressants with those who were not. The result: 21.45 % of patients using antidepressants died, compared with only 12.5% of those who were not on antidepressants. After making adjustments for variables such as cardiac risk, other illness, and other factors, researchers confirmed that antidepressant use was an independent risk factor increasing the risk of mortality by 62%.
Doctors are responsible for communicating risks with patients when prescribing medications. However, drug manufacturers are responsible for researching and reporting the safety and risks of their products to doctors, as well as to patients. When the drug company fails to provide adequate warnings as to risk, they may be liable for damages and losses endured by patients who used their product without understanding the risks involved.
If you or your loved one took Zoloft and suffered unnecessarily with side effects, and you were not warned of these severe side effects prior to use, we will review your case at no cost to determine if you or your loved one may be eligible for compensation for injuries, medical bills, lost income, pain, and suffering. Many who have suffered severe side effects from Zoloft have received compensation for their losses and helped to ensure that the victimization ceases.
To arrange a free evaluation of your case and explore your legal options, call Macaluso & Fafinski today at 718.364.4000 (in the Bronx) or 212.480.9000 (from elsewhere in New York), or simply fill out our convenient online form, and we will respond as soon as possible. The offices of Macaluso & Fafinski are conveniently located to serve the five-borough area and its residents.