Timeline: Selective Serotonin Reuptake Inhibitors (SSRIs)


timeline ssris1974: Eli Lilly discovers and documents Prozac (fluoxetine) as the first major SSRI

1987: Prozac gets final U.S. Food and Drug Administration (FDA) approval and active marketing begins

1989: Joseph T. Wesbecker, a Kentucky man who had been taking Prozac, enters the Standard Gravure Printing Plant and shoots 20 fellow employees, killing eight and injuring 12 before committing suicide shortly after. Represented by attorneys Jerrold S. Parker and Leonard Finz, his family filed a suit alleging that the Prozac had caused the violence (Fentress v. Eli Lilly & Co).

1990: Hala vs. Eli Lilly & Co.- Backed by attorneys Jerrold S. Parker and Leonard Finz, Rhonda Hala files a lawsuit against Eli Lilly & Co. seeking $150 million in compensatory and punitive damages. Hala experienced 150 instances of self-mutilation and six suicide attempts while taking Prozac.

1994: Fentress v. Eli Lilly & Co.- The Joseph Wesbecker trial takes place and a jury votes 9-3 in favor of Eli Lilly. It was later discovered that Lilly settled the case in secret during the course of the trial.

1996: The New England Journal of Medicine publishes a study suggesting that women who take Prozac during their third trimester of pregnancy may have an increased chance of birth complications

2003: The Medicines and Healthcare Products Regulatory Agency (MHRA) expresses concerns over whether Paxil (paroxetine), an SSRI, can increase the occurrence of suicidal thoughts in children and adolescents

2003: The MHRA officially warns that with the exception of Prozac, SSRIs have not proven to be effective in treating depression in young children and adolescents and may actually foster suicidal tendencies.

2004: The FDA also issues a warning about the possible risks of Paxil and holds hearings to evaluate the relationship between suicide and SSRIs

2004: The FDA issues a Public Health Advisory and requested that manufacturers of all modern antidepressants include a “black box” warning that makes clear the increased risk of suicidal thoughts and behavior in both children and adolescents being treated with SSRIs

2004: Health Canada issues an advisory warning that pregnant women taking SSRIs and other anti-depressants during their third trimester may have an increased risk of birth complications such as seizures, feeding and respiratory problems, constant crying and jitteriness and muscle rigidity.

2005: The FDA issues a Public Health Advisory concerning Paxil; the agency states that women taking Paxil during their first trimester may have an increased chance of birth defects, mostly affecting cardiac health

2006: The New England Journal of Medicine publishes a study indicating that exposure to SSRIs in the later stages of pregnancy, particularly after the 20th week of gestation, may increase the chances of persistent pulmonary hypertension of the newborn (PPHN)

2006: The FDA issues Public Health Advisory addressing the relationship between SSRIs and the risk PPHN and also discusses a study that analyzed the rate of relapse in depressed pregnant women who stopped taking their anti-depressants

2007: The FDA requests manufacturers of anti-depressants to update their existing black box warnings to address the increased risk of suicidal tendencies in young adults ages 18 to 24, most notably during the first one to two months of treatment

2011: A study published in the journal Archives of General Psychiatry indicates that the use of SSRIs use during pregnancy can increase the chances of autism and autism spectrum disorders

2011: The FDA revises its 2006 warning, questioning whether the relationship between prenatal exposure to SSRIs and PPHN is legitimate due to “conflicting findings”

2012: Shortly after the FDA released its update, the British Medical Journal (BMJ) publishes a large study supporting the relationship between prenatal SSRI exposure and increased risk of PPHN; the data analyzed more 1.6 million birth records in five different countries including Sweden, Norway, Finland, Iceland and Denmark

Oct. 2012: Human Reproduction journal publishes a study evaluating the use of SSRIs during pregnancy. By reviewing data from previously published studies, researchers concluded that the antidepressants may be too risky to use in women who plan on becoming pregnant. According to the study, SSRIs are associated with an increased risk of miscarriage, birth defects, preterm birth, newborn behavioral syndrome, persistent pulmonary hypertension of the newborn and possible longer term neurobehavioral effects. Furthermore, the authors stated that there is no evidence that SSRIs have benefits for mothers and their children.