FDA Issues Warning On Antidepressant Dangers

When Prozac (fluoxetine) came on the market in 1987 there wasn’t a lot of fanfare. Eli Lilly introduced it slowly and carefully as the first of a new generation of antidepressants called SSRIs (selective serotonin reuptake inhibitors).
First year sales were just respectable, but they more than doubled in the second year. By the third year, Americans spent more on Prozac than on all other antidepressants combined.
Prozac was so successful because it appeared to have fewer side effects than traditional antidepressants. It was less likely to cause sedation, dizziness, constipation or dry mouth.
Other drug companies realized the potential of this market and developed competitors, including Celexa,Effexor, Lexapro, Paxil, Serzone, Wellbutrin and Zoloft. Combined sales of such antidepressants now exceeds $11 billion annually.
Almost from the beginning questions arose about whether Prozac and similar compounds could trigger thoughts of suicide in some people. We received a letter in 1988 from a grieving physician. His daughter had been prescribed Prozac for an eating disorder and a month later took her life by hanging herself.
This ophthalmologist was convinced that Prozac had contributed to her tragic death. We regret that we discounted this story and told him that depressed people sometimes commit suicide when they start treatment. Later, he responded that she had never been depressed nor was she acting like a person who planned to take her life.
In 1990 an article appeared in the American Journal of Psychiatry describing half a dozen patients who developed “intense violent suicidal preoccupation after 2-7 weeks of fluoxetine treatment.” This report stirred up quite a lot of controversy and many psychiatrists downplayed the connection. The FDA also dismissed reports of violence and suicide as coincidental events, not caused by the drugs.
Late last year, however, British regulatory authorities warned physicians not to prescribe SSRI-type medications for people under 18 years old. Prozac was exempted, but they decided other drugs in the class are capable of triggering suicidal thoughts, agitation and self-injury in young patients.
This unexpected move by the British government agency galvanized the FDA to take another look at the issue. Early in February, an advisory panel of experts in the field recommended stronger warnings that these drugs might trigger suicidal thinking or behavior in children or teens. Doctors wrote nearly 11 million prescriptions for such antidepressants to treat adolescents or children in 2002.
Now the FDA has decided to ask manufacturers to put stronger warnings on the label of Prozac and similar antidepressants. The caution is supposed apply to adults as well as children. The agency will encourage drug makers to alert patients to the possibility of symptoms such as agitation, panic, insomnia, hostility, irritability and severe restlessness.
The FDA does not want to discourage appropriate use of antidepressants. But the new warning will encourage family members, physicians and patients to be vigilant for a worsening of depression and thoughts of suicide. Early intervention could save lives.