Zoloft Side Effects
Antidepressants can have serious side effects and, without significant symptom improvement, the risk of injury from taking the drug far outweighs the benefit.
All SSRI (selective serotonin reuptake inhibitor) antidepressants, such as Zoloft, carry black box warnings (the FDA’s most serious warning) stating that “antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short term studies of major depressive disorder (MDD) and other psychiatric disorders.”
Antidepressants such as Zoloft have also been linked to a number of serious birth defects in children born to mothers who have taken the drugs. Zoloft birth defects include:
- Abdominal birth defects
- Autism spectrum disorders
- Heart defects
- Cleft lip and cleft palate
- Skull defects
- Limb defects
- Neural-tube defects
Zoloft side effects also include:
- Nausea and dizziness
- Drowsiness and loss of coordination
- Dry mouth and Loss of appetite
- Shaking/tremors and headaches
- Disfiguring facial and body tics (indicating brain damage)
- Intense withdrawal symptoms
Manipulating the System, Deceiving Consumers
Pfizer conducted six efficacy trials that were carefully designed by the company to show that Zoloft was better than a sugar pill at treating depression. However, in only two of these trials was Zoloft able to “beat” the placebo in terms of lowered scores on the Hamilton Rating Scale.
Four out of six Zoloft trials demonstrated no benefit over placebo when taking the drug and the benefits measured in the two “successful” trials were minimal at best. This occurred despite the fact that these studies were specifically designed to maximize the superiority of the drug over placebo. In fact, the average difference in HAM-D scores between the drug group and the placebo group at the end of these trials was so small that a number of members of the FDA committee that reviewed the data questioned whether the small difference was significant enough to warrant Zoloft approval.
According to the complaint filed by Baum Hedlund, Zoloft’s product insert and label never provided doctors with sufficient information to allow them to conduct the necessary benefit/risk assessment for their patients, nor did it allow patients to make informed decisions about whether to take the drug.
According to the complaint, Pfizer engaged in a practice known as publication bias, in which only clinical trials that achieve positive results (i.e., the drug outperforms the placebo) are published in medical journals. This practice makes it virtually impossible for physicians and consumers to reach an informed decision about a drug’s actual effectiveness, and exposes them to side effects and risks associated with these medications.
Dr. David Healy, a psychopharmacologist and professor at the University of Wales College of Medicine, and a colleague conducted an analysis of Zoloft articles that were “coordinated” by a medical communications company called Current Medical Direction (“CMD”). Pfizer had hired CMD to promote Zoloft in the 1990’s. David Healy & Dinah Cattell, Interface Between Authorship, Industry and Science in the Domain of Therapeutics, 183 British J. of Psych. 22-27 (2003). According to the study, CMD coordinated over 85 medical journal articles about Zoloft during a three-year period. By early 2001, 55 of these articles had been published in journals such as the New England Journal of Medicine, Journal of the American Medical Association (JAMA), Archives of General Psychiatry and the American Journal of Psychiatry. Of course, all of the clinical trial results were favorable to Zoloft. The analysis found that “the CMD-linked articles report[ed] universally positive results” and that there were “significant discrepancies between published data and the raw data from the actual clinical trials.” Most of the 85 articles appeared to have been authored by CMD and, in a number of instances, the authors were listed in Pfizer internal memos as “TBD” (i.e., “to be determined”). The study concluded that:
The combination of distinguished journal, distinguished author, an efficient distribution system and sponsored platforms appears to have led to an impact on the therapeutics domain greatly in excess of 50% of the impact of the rest of the literature on sertraline. The impact of this literature on third-party payers and other interested parties is at present unquantifiable. The question of literature impact would seem to be tied closely to the nature of ghostwriting. Authorship lines from perceived opinion-leaders with minimal company representation and non-declaration of other non-academic authorship inputs increase the likelihood that these articles will be influential with prescribers and purchasers.
Safety Advocates – Baum Hedlund, Aristei & Goldman, PC
Baum Hedlund first began litigating Zoloft cases against Pfizer in 1999 when it filed one of the first Zoloft suicide cases in the nation and then went on to represent dozens of families in Zoloft suicide and suicide attempt cases against Pfizer. The firm has represented over 3,000 individuals across the United States in all types of SSRI antidepressant cases. Baum Hedlund represented hundreds of families across the United States whose children are suffering from, or who have died from, a major birth defect after the mother took an antidepressant during pregnancy.