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David Baxter PhD

Late Founder
Prozac Appears Safe and Effective in Teens
Early study results suggest combo of drug plus psychotherapy is best
By E.J. Mundell -- HealthDay Reporter

WEDNESDAY, June 2 (HealthDayNews) -- While it may not settle the debate entirely, preliminary findings from a major U.S. government-funded study suggest that antidepressants do not raise the risk of suicide in adolescents.

The findings should provide some comfort to the parents of millions of American teens who take Prozac and other selective serotonin reuptake inhibitor (SSRI) drugs to battle depression. Earlier this year, isolated reports of teens taking their own lives while on SSRIs led the U.S. Food and Drug Administration to issue a warning regarding their use in younger patients. In the United Kingdom, health officials went even further, banning the use of all SSRIs except Prozac for patients under the age of 18.

However, "people who are concerned about this issue can be reassured" by the results of the new research, said Dr. Marvin Lipkowitz, chairman of psychiatry at Maimonides Medical Center in New York City.

"The take-home message," he said, "is that the medication is, overall, excellent -- there's no question."

According to a report Wednesday in The New York Times, researchers led by Duke University's Dr. John March assessed ongoing changes in the mental health of 378 adolescents aged 12 to 17 diagnosed with moderate to severe depression as part of the Treatment for Adolescents with Depression study.

Each of the young patients received one of four different treatments over a 36-week period: Prozac alone; Prozac in combination with cognitive behavioral therapy (where patients talk out their problems with a therapist); cognitive behavioral therapy alone; or a placebo pill.

The study was funded entirely by a grant from the National Institute of Mental Health.

Although March's team collected data on the study subjects for a period of one year, they have so far only analyzed data from the first 12 weeks of therapy.

Presenting those preliminary, unpublished findings at a psychiatric meeting Tuesday in Phoenix, the researchers reported that a combination of Prozac plus "talk" therapy worked best, with 71 percent of those patients responding well to treatment. Next best was Prozac alone, which improved depression in 61 percent of patients. Just 43 percent of patients treated with talk therapy alone achieved significant depression relief, slightly better than the 35 percent found in patients taking a placebo.

However, the researchers stressed that any therapy seemed to reduce risks for suicide. None of the 378 participants took their lives during the trial, the researchers noted, although there were six attempted suicides recorded.

Five of the six attempted suicides occurred among patients taking Prozac, the researchers said. Still, that number remains statistically very low, and March told the Times that "these adverse events are extremely rare."

According to Lipkowitz, the study suggests that Prozac's benefits for depressed teens far outweigh its risks. "Although each death is a tragedy, the number of people who have benefited from these medications is significantly greater than the number who have been harmed by them," he said.

But he agrees with the current FDA recommendation that young patients taking Prozac should also seek the care of a psychologist or psychiatrist at the same time, to monitor their progress. "Unless one is completely enamored of the pharmacology-only approach, what these findings demonstrate is that, for depression and especially in teenage patients, human contact is important," he said.

Lipkowitz believes the findings will be less welcome to representatives of the nation's HMOs. "The insurance companies that pay for medical care will object to having all this money spent on talking with the child, which is only going to increase costs," he said. "I think that while it's a noble fight, it'll take time for these findings to have any significant effect. But it's a very valuable beginning."

The next real test lies ahead, as experts at the FDA mull over the study findings. The full results of the study are still to come, the researchers said. "We're all holding our breath to see what the FDA is going to do," March told the Times.

In the meantime, concerns about SSRI safety are leading to legal battles in the nation's courts.

New York state Attorney General Elliot Spitzer announced Wednesday that he has filed a lawsuit against drug giant GlaxoSmithKline, alleging that the company "engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil, a drug used to treat depression."

As it stands, only Prozac is currently approved by the FDA for use in fighting depression in children. Spitzer's lawsuit alleges that GlaxoSmithKline "withheld" and "misrepresented" research on Paxil's effects in teens and young children, in an attempt to encourage doctors to engage in "off-label" use of the drug in younger patients. According to Spitzer's office, U.S. doctors wrote more than 2 million prescriptions for Paxil for use by children in 2002 alone, resulting in sales in excess of $55 million.

More information

For details on treating children with depression, visit the National Institute of Mental Health.

SOURCES: Marvin Lipkowitz, M.D., chairman, department of psychiatry, Maimonides Medical Center, New York City; June 2, 2004, The New York Times; June 2, 2004, statement and complaint, New York State Office of the Attorney General
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