The Food and Drug Administration is in a bind. Millions of people, including many children, have taken antidepressants like Prozac, Paxil and Wellbutrin. Physicians and patients assumed that the FDA seal of approval on these drugs meant they were safe and effective.

But such medications have come under increasing scrutiny in recent months. An FDA staffer, Andrew Mosholder, MD, MPH, was given the task of analyzing 22 studies. His conclusion: “short-term pediatric trials of antidepressant drugs demonstrate an increased rate of suicidal events with active drug compared to placebo.” He also said that there is not adequate information to tell if antidepressants other than Prozac are effective for children.

The idea that drugs designed to fight depression and prevent suicide could potentially make things worse for some kids was a shocker. FDA officials apparently felt that Dr. Mosholder’s conclusions went too far. He was not invited to present them at a crucial FDA meeting on February 2.

This has led to Congressional inquiries. Senator Charles Grassley (R., Iowa) has said, “I’m very interested in finding out just why FDA would not let Dr. Mosholder speak out about his findings.”

So far, no one has asked whether adults might also suffer from thoughts of suicide triggered by antidepressants. Why children, but not adults, might be susceptible to this complication hasn’t been addressed by the FDA.

Everyone agrees that many people benefit from drugs like Prozac and Zoloft. But awareness seems to be growing that some patients are susceptible to anxiety, severe restlessness and even panic while taking popular antidepressants.

One woman reported to us that her husband’s personality changed after starting Prozac. “He became suicidal and had nightmares about death. His doctor kept adding more and more drugs. Things became worse and he tried suicide six or seven times over the next year. After stopping the medication it took months for him to get back to normal.”

A psychiatrist, Nanette Gartrell, told us her story about Wellbutrin. She had prescribed this antidepressant to many patients with great success. Then she became depressed about the death of a friend and her doctor prescribed Wellbutrin for her.

Within a short period of time she was experiencing disabling panic, agitation and tremor. Even her own psychiatrist did not recognize that these were possible side effects of the medication. When she stopped Wellbutrin, they gradually began to fade away.

Harvard psychiatrist Joseph Glenmullen and David Healy, psychiatrist and Director of the North Wales Department of Psychological Medicine, have been trying to alert their colleagues to these potential hazards for years. Both believe the drugs are valuable in treating many patients. But they also warn that some individuals are vulnerable to potentially devastating side effects such as severe restlessness or thoughts of suicide and must be monitored closely.

If you would like to hear an hour-long conversation with these psychiatrists, you may wish to order a CD of our radio interview on antidepressants. Please send $15 to Graedons’ People’s Pharmacy (Dept CD-493); PO Box 52027; Durham, NC 27717-2027.

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