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FDA Urges Caution On Prozac, 9 Others

Doctors are told to watch anti-depressant patients for suicidal thoughts; Stronger warning labels advised

Mar 23, 2004 | Baltimore Sun a href="">More information on Serzone side effects

The Food and Drug Administration told doctors yesterday to carefully monitor patients on 10 popular anti-depressants for suicidal thoughts and asked manufacturers to add the warning to drug labels.

The FDA's public health advisory stopped short of saying the drugs can actually increase depression or lead to suicidal thoughts. But it advised doctors to monitor both adults and children for those symptoms, as well as possible side effects including hostility, anxiety and severe restlessness that could be precursors to suicide.

"We think this is good advice whether the drug is at fault or not," Robert Temple, the FDA's director of medical policy, said in a conference call with reporters. "It really applies to any anti-depressant."

Some patient advocates and physicians welcomed the stronger labels, while others derided them as years late, too weak and unlikely to change doctors' prescribing habits.

An FDA advisory committee suggested changes last month after hearing emotional testimony from dozens of people, including parents who said anti- depressants had abruptly driven their children to kill themselves.

While most of the testimony concerned children, some of it also referred to adults echoing warnings that first surfaced more than a decade ago, when Prozac became the first drug in the new class to win approval.

Yesterday's advisory, encompassing patients of all ages, is an interim measure while the FDA finishes analyzing clinical trials to determine whether any of the anti-depressants may drive some patients deeper into depression.

The warning applies to all uses of the drugs, which are frequently prescribed for maladies other than depression, including obsessive-compulsive disorder.

The issue is a difficult one for regulators, who say they don't want to prevent doctors from prescribing drugs that have helped many patients or ignore reports of occasional dangerous side effects, including suicides in a small percentage of cases.

The drugs as a group are also dear to pharmaceutical companies because they include some of their top sellers. In the United States alone, estimates of anti-depressant sales range from $11 billion to $12.5 billion a year.

Yesterday's advisory encompasses some of the most popular: Prozac, Zoloft, Paxil, Luvox, Celexa, Wellbutrin, Effexor, Serzone, Remeron and Lexapro.

Only one of them, Prozac, is approved as an anti-depressant for children, but doctors are free to prescribe any drug to children that is approved for adults.

Concerns about their effects in children drew attention last year after pharmaceutical companies tested some of the drugs in young people at the FDA's request in exchange for extended patents on the drugs. The FDA found evidence in the results that some of the drugs might cause increased thoughts of suicide, although no deaths were documented in the trials.

Subsequently, British health authorities warned doctors to avoid prescribing five of those drugs to children with severe depression, but cleared Prozac. The others, authorities said, had not been proved effective for young people.

The FDA has declined to follow suit. Officials there argue that just because the drugs haven't been proved effective in specific clinical trials with children doesn't mean they aren't.

"That is doublespeak," complained Julie Zito, an associate professor of pharmacy and psychiatry at the University of Maryland and critic of that argument. "That is nonsense."

What the FDA suggested yesterday but did not require is that manufacturers strengthen warnings on the inserts in packages of the 10 anti-depressants shipped to pharmacists and physicians.

Some of the warning language would be in bold type, though the FDA stopped short of requiring the drugs to include the most severe, "black-box" warning - so called because the language is enclosed in a black rule.

The agency also did not require that patients be given the information when they pick up their prescriptions. Critics said that as a result, many patients would never know about the new warnings.

In addition to asking doctors to closely monitor patients when starting them on anti-depressants or changing their doses, the advisory asked doctors to watch for other symptoms that include increased anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, a severe restlessness known as akathisia and mania.

It also recommended that doctors who decide to stop prescribing the medicines as a result of side effects gradually taper off dosages.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, welcomed the FDA action, noting that his organization filed a petition with the FDA nearly 14 years ago, asking for a black-box warning on Prozac because it was concerned about the drug's effect on some adults.

"We felt then that there was enough evidence," he said.

Wolfe said he doesn't understand why the FDA is waiting for definitive analysis to issue even more severe warnings. "This is a good example of common sense being trumped by impossible-to-do epidemiologic studies," he said.

Nonetheless, Dr. Joseph Glenmullen, a Harvard University clinical instructor in psychiatry and author of the book Prozac Backlash, called the advisory "a major step forward."

And Cynthia Folcarelli, executive vice president of the National Mental Health Association, said the FDA did a good job of warning doctors and consumers without suggesting that people avoid anti-depressants.

"We would not want people to think they shouldn't seek help if they have symptoms of depression," Folcarelli said. "Depression can be a deadly illness."

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