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
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