Feb. 2, 2004 -- Renewed concerns about the safety of the antidepressants have prompted the Food and Drug Administration to convene hearings today to determine whether antidepressants like Paxil and Zoloft are unsafe for use in children under 18.
Last summer, the British drug authorities announced findings of an associated risk of increased suicidal behavior. On trial is a class of drugs called specific serotonin reuptake inhibitors (SSRIs), which include Prozac, Paxil and Zoloft. Currently only Prozac is approved by the FDA for use in children.
For parents whose children have had terrible experiences while taking antidepressants, the FDA hearing is long overdue.
Teenager Corey Baadgaard was taking Effexor when he walked into his honors English class with a rifle and held his classmates hostage. One of the antidepressant's actions is to increase serotonin like Prozac and Paxil. "I've never been in a fight before, never done anything like that, never wanted to hurt somebody," Corey told World News Tonight correspondent Lisa Stark.
But doctors who have seen the drugs work "miracles" in children worry one of their best weapons for treating depression in kids might be taken away without any hard science to support a ban.
"The British decision [to ban all SSRIs but Prozac for use in children] was not based on science," says adolescent psychiatrist Chris Okiishi of the University of Iowa Hospitals and Clinics. "These are the only effective medications we have for children."
Benefits Outweigh Risks?
Among the evidence the FDA will consider is a report from the American College of Neuropsychopharmacology, or ACNP, which convened a task force in September 2003 to study the data linking antidepressants to suicide in teenagers.
The ACNP examined a total of 15 clinical trials of SSRI — totaling more than 2,000 kids and teens — including those reviewed in Great Britain last year. It concluded there is no reliable evidence linking antidepressants to increased suicide in teenagers.
Instead, ACNP said there is good reason to believe antidepressants help prevent adolescent suicide. The review of over 2,000 children on antidepressants found not one suicide. The report also notes the British study found only slight increases in suicidal thinking in kids who were taking antidepressants.
The ACNP considered other evidence as well.They reviewed a recent study on 49 teenagers who had committed suicide, 24 percent of whom had been prescribed antidepressants.However, none of the kids tested positive for the SSRIs at the time of their death.This suggests the teenagers may have been less suicidal on the medication than off of it.
Finally, the report examined suicide rates in countries where the antidepressants are prescribed.They found teen suicide has dropped about 33 percent among populations using SSRI antidepressants over the past 14 years.The reduction followed several decades of increases in youth suicide.
Suicide a Risk with Depression
Doctors admit there is always a risk of suicide when treating a severely depressed patient.As patients start to feel better, energy and motivation sometimes return before the suicidal thinking has faded.
"You get patients who are too depressed to commit suicide," says Dr. David Fassler, a trustee of the American Psychiatric Association who is testifying about the antidepressant safety at the FDA hearing."Patients start treatment and then they feel just better enough to go through with it."
Others question whether the antidepressants might have more of a "rebound effect" in children.The kids feel better when the drugs are in their system, but may feel even worse as the drugs wear off.
We know kids metabolize drugs faster," Okiishi explains."One possibility is that we may not be giving them enough."
Doctors agree it is important to watch a person starting antidepressants very carefully.Jay Reeve, senior psychologist at Bradley Hospital in Providence, R.I., explains, "We often admit [severely depressed kids] to the hospital.We watch them very closely for at least three to four days.After that, we make sure we have a lot of parental education about possible side effects."
But with increased suicidal thinking as a possible side effect, some feel you can't be too careful. Dr. Thomas J. Moore of George Washington University told World News Tonight, "I believe there is not enough evidence that these drugs are safe."
The ACNP report notes safety evidence in adults is much better."More than 20,000 adults have been studied in clinical trials of SSRIs and other antidepressants … Analysis of the database found no relationship between SSRIs and suicidal attempts or actual suicides in adults."
Experts hope the FDA hearing will provide more answers to the question of effectiveness and safety of antidepressants in children."We need large scale multi-site studies," Fassler says."A hearing to evaluate what we know and what we don't know is a good thing."
Verdict Not Likely to Come Soon
For the millions of people taking SSRIs for depression, a definitive answer is not immediately in sight.Dr. Russell Katz of the FDA explains: "We don't believe we have the information at the moment to be able to make that decision, and we think it is very, very important to get this correct, because a mistake in either direction can have very significant health consequences."
Meanwhile, some question whether the FDA panel may be overly biased in favor of the drug companies.
The Center for Science in the Public Interest, for instance, has urged the FDA to remove three of 11 scientists on one of its advisory boards evaluating the link between antidepressants and suicide in youths because they have been paid consultants for the companies that make the drugs under investigation.
The FDA says they are just beginning the review process and may not have an answer until next summer.In the meantime, they have urged doctors to be especially careful when prescribing antidepressants to children.
All doctors emphasize parents should not stop their children's antidepressant medications without first talking to a physician.
"Drugs are not the whole answer," acknowledges Fassler."But there is a high risk of not treating kids."
Okiishi explains, "I have 15-20 patients with a parent overseas in the Gulf.The parents heard the British report on the BBC [about SSRIs and suicide] and wrote home to have their kids taken off the medications without consulting me. I ended up with some pretty sick kids."
Okiishi says his young patients are back on their medications and doing fine.