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Doctors Debate Safety of Paxil for Kids

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Does Paxil make children more likely to commit suicide?

That's a question that has been on the minds of many parents and doctors since the Food and Drug Administration recommended in June that use of the popular antidepressant be discontinued for children under 18.

The action followed a stronger ban on Paxil by the British Medicines and Healthcare Products Regulatory Agency and an evaluation of the entire class of selective serotonin reuptake inhibitor antidepressants, which includes Prozac, among others.

Paxil is manufactured by GlaxoSmithKline, based in the United Kingdom. It is the second-most popular antidepressant in the United States, with $2.5 billion in sales in 2002.

"The FDA received information from three clinical studies in pediatric patients that failed to show that the drug was more effective than placebo ... and reports from studies that showed Paxil in this population was associated with an increased risk of suicidal thinking," said FDA spokeswoman Susan Cruzan.

Cruzan also emphasized that Paxil has never been approved by the FDA for use in children under 18.

But even as the FDA deepens its investigation into Paxil and similar drugs, many experts are quick to respond. Even doctors who do not routinely prescribe Paxil to younger patients expressed concern about the FDA's recommendation.

Dr. Francis Solano Jr., president and chief medical officer of the primary care services of the University of Pittsburgh Medical Center, cautioned against drawing hasty conclusions.

"I have found Paxil to be a very effective drug. The class of patients on the drugs is more a problem than the class of drugs. Suicide remains a big problem in teens and elderly men even with drug therapy," said Solano.

Dr. Lyle Berkowitz, medical director of clinical informatics at Northwestern Memorial Physicians Group in Chicago, was skeptical of the causal relationship reported by the British investigation.

"I think the real story is that these patients are already suicidal and these medications might give them a little more energy and motivation to actually kill themselves, but do not inherently increase their depression," Berkowitz said.

The general consensus among physicians is that while antidepressants may on occasion cause problems, they are an essential tool in the ongoing battle against depression.

Dr. Adelaide Robb, a psychiatrist at the Children's National Medical Center in Washington, D.C., argued that even though 3.2 percent of children on Paxil experienced suicidal thoughts or actions, prescribing the drug is preferable to doing nothing.

"The rate of suicide attempts in untreated depression is at 10 percent," she said. "Episodes of mood disorder tend to recur more frequently with each episode, last longer, and become more treatment resistant the longer a patient goes without treatment."

Robb said none of the patients became suicidal in the trial she headed on using Paxil to treat pediatric major depression disorder.

No Drug Is Perfect

Adverse effects are nearly always present in a small proportion of patients, and doctors caution against generalizing a few problem cases to the whole population.

"I have used Paxil in dozens of adolescents. It helps some and not others, as with all antidepressants," said Dr. John Messmer, medical director of the University Physician Group in Palmyra, Pa.

Dr. Thomas Schwenk, professor of family medicine at the University of Michigan in Ann Arbor, agreed that the negative claims against Paxil needed to be evaluated more thoroughly.

"Like all drugs, [Paxil has] many positive benefits and many patients have benefited tremendously, perhaps even had their life saved," he said. "The problem with all these issues and studies is that the specific issues for a specific patient are so much more complex and individualized."

Messmer also noted that an increased risk of suicide in the early stages of antidepressant treatment has been long recognized. "Any doctor treating depression must be aware of the risk of suicide as the depression lifts."

"The first two to three weeks after starting any treatment for depression is a period at risk for suicide and patients should be monitored closely and frequently during that period of time by a psychiatrist," Robb concurred.

Proceeding With Caution

However, some doctors are heeding the FDA's call and reconsidering prescription of Paxil for younger patients.

"I use Paxil quite a bit. I will continue to use it but I won't prescribe it for patients under 18 until this controversy is cleared up. I will try to change patients under 18 who are now on Paxil to another drug," said Dr. David Miller, a physician at the Cabarrus Family Medicine clinic in Concord, N.C.

Dr. Carol Forster, director of pharmacy management for Kaiser's Mid-Atlantic medical group, said that shortly after the FDA recommendation was made, her medical group communicated the issue to all doctors who had prescribed the agent to patients, as well as those who take care of teens.

"It was recommended that no new prescriptions would be given to teens, and a conversation would occur with patients and parents who were already on the agent. A mutually agreeable decision would be reached as to whether the drug would be continued or not," she said.

"We feel that although our own anecdotal experiences may have not pointed toward any significantly higher potential of Paxil to cause suicides in teens, we needed to pay attention to the info in the press and take action immediately," added Forster.

The FDA recommends that caretakers of pediatric patients already receiving treatment with Paxil for major depressive disorder talk to their doctor before stopping use of the drug. Patients should not stop use of Paxil without first consulting their physicians, and it is important that Paxil not be abruptly discontinued.

Whether or not young patients should keep taking Paxil is still a topic of intense debate. But regardless of the outcome, experts agree that antidepressants have played a significant role in bettering the lives of many of their patients.

"The most gratified patients I have had over my entire carrier are the ones who have had the burden of depression removed from their and their families' backs," said Dr. Neil Brooks, a family physician in Vernon, Conn.

"Ask a severely depressed patient why they would consider suicide and they will tell you that death is less painful then what they are experiencing," Brooks said. "Saving an emotional life is as important as a physical life and in the end may be more important to society."

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Copyright 2003 All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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