Deciding to take a prescription drug is no easy task. Many people spend time weighing the risks versus the benefits, and those that decide to undergo treatment via a daily prescription often find that the efficacy of the chosen drug far outweighs any side effects. Unfortunately for some, they find out all too soon that their decision may have been a poor one, as in the case of many former Zoloft users.
What is Zoloft?
Sertraline hydrochloride, sold under the brand name Zoloft, is a drug marketed as an antidepressant. Zoloft comes in 10mg, 25mg, and 100mg tablets and was developed and marketed by American pharmaceutical giant Pfizer, Inc. beginning in the early ‘90s. Zoloft is often used to treat severe depression, obsessive-compulsive disorder, panic disorder, and anxiety disorders. Since 2007 is it said that over 29 million prescriptions have been sold.
How Does Zoloft Work…or Does it?
Zoloft is a Selective Serotonin Reuptake Inhibitor (SSRI); a class of antidepressants that prevents receptors in the human brain from absorbing serotonin that has already been released. Serotonin helps maintain feelings of happiness in people, by preventing re-absorption Zoloft is said to ease negative feelings. SSRIs often take several weeks to take effect, and have been known to cause several side-effects.
A recent Zoloft lawsuit filed by Plaintiff, Laura Plumlee makes allegations that Zoloft is no more effective than a placebo filled with sugar. Plumlee underwent treatment for her depression for three years while taking Zoloft, but says that the drug did nothing to help her ailment. Pfizer denies these allegations responding to the claim as frivolous and using studies to back up its assertion that Zoloft is an effective means to treat those with depression. Plumlee’s lawyer on the other hand says just the opposite and cites clinical studies to bolster his position.
What are the Problems Associated with Zoloft?
Zoloft has been the target of several lawsuits and is most notably accused of causing birth defects in children born to mothers who took Zoloft during their first trimester of pregnancy. In 2006 the FDA issues a warning regarding Zoloft and its relations to birth defects.
The following defects have been reported with respect to women taking Zoloft while pregnant:
- Cleft lip or palate
- Clubbed foot
- Craniosynostosis (premature skull fusion)
- Delayed development
- Enlarged heart
- Gastroschisis (a defect of the umbilical cord)
- Macrocephaly (abnormally large head)
- Narrow aorta
- Neural tube defects (opening in a child’s spinal cord or brain)
- Persistent Pulmonary Hypertension (PPHN)
- Premature birth.
- Septal heart defects (malformation and separation of the Septum)
- Spina bifida (neural tube defect)
- Withdrawal symptoms
Other Zoloft Side Effects
Like many other antidepressant drugs, Zoloft has been found to cause increased thoughts of suicide, and complications for those with pre-existing heart conditions. The FDA has considered these additional side effects, but has only added additional package warnings but not taken the drug off the market.
The FDA now requires more stringent product warnings and prescription requirements. In 2004 the FDA imposed “black box” warning standards for several antidepressants such as Zoloft. A black box warning is known to be an extreme measure in the prescription drug industry, however there are have been no efforts to remove the product from the market and no recall of Zoloft. In addition to many questioning the efficacy of Zoloft as an antidepressant, Pfizer has faced numerous class action lawsuits to date.
Status of Zoloft Litigation
Last month the federal district court began a selection process for the early trials set to begin next year. These trials, known as Bellwether trials (a trial to indicate future trends in a specific litigation), will be comprised of 25 lawsuits (chosen from more than 250 currently pending), 12 chosen from Plaintiff’s attorneys, the remaining 13 cases will be submitted by Pfizer’s counsel. Following discovery and pretrial proceedings, the cases will begin trial in September of 2014. The outcome of these Bellwether trials will reveal any patterns that may exist among the legal issues, thus fostering a basis for settlement agreements for future claims against Pfizer regarding Zoloft.
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