Shortly after Prozac was approved for treating depression in 1987 we received a heartbreaking letter from a physician. He was writing as a bereaved father:
“My daughter committed suicide in 1988 one month after being put on a new medicine called Prozac. She was not depressed, but Prozac was prescribed for an eating disorder.
“We believe Prozac is responsible for her suicide. She did not seem suicidal before she started taking this medicine, and even the day before she hanged herself, she promised to take care of her neighbor’s cat while they were on vacation.
“Have you ever heard of another case of someone committing suicide while taking Prozac?”
At that time there was no evidence that antidepressant medications like fluoxetine (Prozac) could trigger suicidal thoughts or actions. When we discussed this case with the FDA and the manufacturer, we were told that depressed people sometimes commit suicide and that the drug could not be to blame.
Psychiatrists we consulted were quite adamant that antidepressant medications prevented suicides in depressed patients. In other words, the depression had them in such a deep dark place that they were not likely to act out their suicidal thoughts. As the medication kicked in and they began to recover, some patients might move from a lethargic state to a more energized place. That, they insisted, was the reason such patients might attempt suicide, not the antidepressant drugs.
That seemed to be the end of a very sad story.
Despite the official reassurance that Prozac (and other new antidepressants) could not be to blame, we had a nagging suspicion that something was not quite right. We heard from other family members that a loved one had committed suicide.
In 1990 the first hint of a connection between fluoxetine and suicide was published (American Journal of Psychiatry, Feb. 1990).
The Harvard psychiatrists noted in this article that:
“Six depressed patients free of recent serious suicidal ideation developed intense, violent suicidal preoccupation after 2-7 weeks of fluoxetine treatment. This state persisted for as little as 3 days to as long as 3 months after discontinuation of fluoxetine. None of these patients had ever experienced a similar state during treatment with any other psychotropic drug.”
Most mental health professionals dismissed this report. The FDA considered it and decided there was not enough evidence to support a warning. The drug company said that its highly successful antidepressant was no more likely to cause suicidal thoughts than any other form of therapy. Health professionals were quick to point out that, it was “only” six depressed patients. Such case reports were not considered “scientific” evidence of a connection.
Nevertheless, we took the article very seriously. The first thing we did was contact the bereaved father who had contacted us in 1987 about his daughter’s suicide. We apologized for not taking his suspicions more seriously. We shared the report from the Harvard psychiatrists. Although we had not heard of other similar cases, we began to write about this unexpected and paradoxical complication of antidepressants.
In June of 1990 we heard from another grieving family:
“Your column about the woman who committed suicide while taking Prozac really caught my attention. My nephew also hanged himself this spring in his dormitory room in college.
“He had been taking Prozac for about the last two months for depression. The school psychiatrist had told his family that his problems and insecurities were “normal” for a college student, and his death came as a tremendous shock.
“His parents had spoken to him the evening before and said he was fine. His roommate was with him during most of the day while they studied for exams, and said he was in good spirits. Late in the afternoon his roommate left for an hour, and when he returned found my nephew hanged by a make-shift apparatus. It did not seem to have been preplanned.
“I realize drugs have both positive and negative effects. I am confident the drug companies keep very good records of all the adverse reactions of their drugs. But the only way they can know about a reaction is if people report it.
“I encourage anyone on any drug who experiences an adverse reaction to report it in writing to the pharmaceutical company which markets it. If a truly harmful reaction really IS a side effect of a drug, in time a pattern will emerge and the drug will be taken off the market. But without reports, the drug manufacturer will be unable to tell if my nephew’s experience was just an isolated tragedy affecting our family, or if there really is a link between Prozac and suicide.”
We responded to this aunt with the following cautious answer:
“We have received a number of such tragic reports in recent weeks, but depressed people do sometimes attempt to take their lives whether they are on medication or not.
We have contacted the company and it maintains that Prozac is not associated with a higher incidence of suicide than other treatments for depression.
“We agree with you that it is essential for people to report all serious side effects to the drug company or the Food and Drug Administration (FDA).”
In April, 1991 we published another heart-breaking message in our syndicated newspaper column:
“I believe that Prozac may be implicated in my daughter’s death by self-immolation. I suspect that the drug intensified her anxiety to an unbearable degree and provoked self-injurious and highly dangerous behavior not present before she started taking the drug (in January 1989).
“Beginning in April of 1989, I was unable to leave her by herself. She was terrified by violent obsessive thoughts of killing herself. I feel these symptoms, which emerged several months after she began treatment with Prozac, were substantially different from those observed through 1988 and that there may be more than coincidence involved.
“I don’t know whether any of the doctors who treated her chose to report her case to the company or the Food and Drug Administration. How can I make sure the proper authorities are informed?”
By then we had received dozens of letters from people who were convinced that Prozac in some way contributed to severe anxiety, violent behavior or a preoccupation with suicide. Nevertheless, the drug company (Eli Lilly) steadfastly maintained that Prozac was not responsible. Despite such rebuttals, but we were really alarmed.
The poignancy of the letters we were receiving convinced us that patients and their families needed to be warned of the possibility of such a potentially deadly side effect. Although we continued to report such tragedies to the FDA, the agency, like the manufacturer, seemed intransigent in its position that depressed people commit suicide regardless of the treatment they receive.
But the letters kept coming; dozens and then hundreds. They broke our hearts. We continued to press the FDA to do something.
Finally, fourteen years after we started alerting authorities to a problem with Prozac, an advisory panel for the FDA voted to add suicide warnings to the labels of all antidepressants, not just those like fluoxetine that affect the brain chemical serotonin.
A Black Box Warning About Antidepressants Arrives!
In October 2004, the agency required a black box warning reading, in part:
“Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.”
Many doctors were outraged that the FDA required such a warning. They worried that it might scare parents unnecessarily and that children would go untreated and commit suicide as a result.
More recently, studies have revealed that the new generation of antidepressants was barely better than placebos at relieving depression in clinical trials (PLoS Medicine, Feb. 26, 2008). Although some people do benefit significantly, others don’t or experience intolerable side effects.
A recent editorial in the journal BMJ (April 21, 2015) suggests that part of the popularity of the SSRI (selective serotonin reuptake inhibitors) antidepressants like fluoxetine, paroxetine or sertraline is due to the idea that they are remedying a chemical imbalance in the brain. The author, David Healy, MD, concludes that this concept is a myth: “No one knew if SSRIs raised or lowered serotonin levels; they still don’t know.”
Despite the lack of solid evidence, mental health professionals have embraced the theory that drugs correct a chemical imbalance. There is, however, growing support for nondrug approaches such as lifestyle interventions including exercise, light exposure and talk therapies (Clinical Psychology Review, online Apr. 20, 2015).
There is more information about such approaches in our Guide to Dealing with Depression.
The Bottom Line
It is incredible to us that it took the FDA so long to recognize a potentially deadly drug reaction, especially since we had notified executives at the FDA that we were receiving so many heartbreaking stories about suicide linked to the newer antidepressants like Prozac. We were also disappointed in doctors who insisted that such an association was impossible. To this day, there are physicians who don’t believe antidepressants can trigger suicidal thoughts or actions, despite the FDA’s black box warning on all such drugs. In fact, some physicians are now calling for elimination of the black box suicide warning! They feel that it might discourage some doctors from prescribing antidepressants or some patients from taking these medications.
If you too are incredulous, You may find our book, Top Screwups of interest. It documents in great detail the reluctance of modern medicine and our regulatory agencies to acknowledge adverse drug reactions and medical misjudgments. The book provides details so you and your loved ones can avoid these kinds of disasters.
Share your own story below. What do you think about the FDA’s slow reaction to adverse drug reports such as those shared above? Please vote on this article at the top of the page.