Trouble in Prozac Nation

Fortune
Nov. 29, 2005

Wonder drugs of the 1990s, Prozac and its kin have been prescribed to tens of millions of people. But a growing backlash may portend the end of an era.

By David Stipp

Can Prozac make you want to die? The idea seems strange, given that the drug and similar antidepressants are supposed to do just the opposite. Yet that is what Kimberly Witczak believes happened to her husband. Two years ago Tim "Woody" Witczak killed himself at age 37, soon after going on Pfizer's Zoloft—the top-selling member of Prozac's class of drugs, known as selective serotonin reuptake inhibitors, or SSRIs. Her husband was an upbeat, happy man, says Kim Witczak. Shortly before his death he had been named vice president of sales at a startup that sold energy-efficient lighting. When anxiety about the new job caused insomnia, he was prescribed Zoloft. He began suffering from nightmares, profound agitation, and eerie sensory experiences after a couple of weeks on the medicine—at one point, she says, he said he felt as if his head were detached from his body. Then he seemed to calm down. But about five weeks after his first dose, he hanged himself from the rafters in their garage when Kim was out of town. He left no suicide note.

"Woody's death was the most out-of-the-blue, out-of-character death," she told FORTUNE recently. "He had no history of mental illness." Kim Witczak, who lives in Minneapolis, has sued Pfizer, alleging that Zoloft induced the suicide and that the company failed to warn about the drug's potential to cause perilous side effects. Pfizer declined to comment while the case is in litigation, but a spokesman asserted that there is "no scientifically based" evidence to suggest Zoloft can induce violent acts. It's not the first time SSRI makers have faced complaints related to suicide or other forms of violence. They have fended off or quietly settled scores of such suits over the years without significant injury to their drugs' reputations.

But the Witczak case, which may play out in court next spring, is likely to put SSRIs on trial as never before. For one thing, Kim Witczak has emerged as a formidable crusader. Poised and articulate, she has appeared at congressional and Food and Drug Administration hearings (most recently this month) to tell of her tragedy and the dangers of SSRIs. What's more, her suit is likely to spotlight disturbing information that drug companies and U.S. regulators have been aware of for years—but that most doctors prescribing the drugs have known little or nothing about.

Controversy about SSRIs' side effects flared into national prominence last year when they and older antidepressants were shown to double the risk of suicidal thoughts and behavior in children and adolescents. That discovery prompted the FDA to slap a stern "black box" warning on the drugs' package inserts. (Among other things, it cautions doctors to monitor young patients closely in their first months on SSRIs.)

A black-box warning about suicidal thoughts and behavior in adults may very well be next, say a number of experts interviewed by FORTUNE. "I'm fully expecting that the same [risk found in young patients] will be found in adults," says Dr. Richard Kapit, an ex-FDA official who handled the agency's first safety review of Prozac before its approval in 1987. (He now works as a medical writer and consultant in Bethesda, Md.) In fact, last summer the FDA warned that several recent studies suggest that SSRIs and other antidepressants raise the risk of suicidal behavior in adults as well as kids. The agency added that it is reviewing "all available data" on the issue in an investigation expected to take a year or more.

Risk of suicide isn't the only problem dogging SSRIs. For example, GlaxoSmithKline faces thousands of lawsuits on another side effect, severe withdrawal reactions to its drug Paxil, one of the fastest-acting SSRIs. Last year British policymakers moved to discourage the use of SSRIs to treat mild depression. And a recent scientific analysis has challenged long-held assumptions about how the drugs work. That could undercut drugmakers' assertions that SSRIs are well understood, potentially increasing doubts about their safety.

A black-box warning for adults could have huge repercussions, vaporizing billions of dollars of future sales, increasing pressure on policymakers to curtail direct-to-consumer drug ads, and prompting a slew of lawsuits. It could also complicate drugmakers' efforts to roll out new antidepressants to replace current ones as the drugs go off patent. The ultimate fallout could well equal or exceed that from Vioxx, the Merck painkiller whose saga of potentially lethal risks, dodgy marketing, and damaging courtroom disclosures has given Big Pharma the look of an ethical disaster zone. If so, it would add a sad twist to a tale in which so many people have been helped.

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