FDA urges caution on drugs for depression — (The Houston Chronicle)

SSRI Ed note: Doctor prescribes Zoloft for happy 77-yr-old Catholic man with an itch, he loses interest in his friends, tears up his rosary and kills himself.

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The Houston Chronicle

March 23, 2004, 9:04AM

By ERIC BERGER, Houston Chronicle Medical Writer    Ha Lam / Special to the Chronicle

Close watch needed on suicidal tendency

Ron Dusek believes his father, Cyril, committed suicide after taking Zoloft. After doctors increased the medication, he says, his father tore his rosary apart and shot himself a few days later.
The Food and Drug Administration on Monday asked 10 antidepressant drug manufacturers to change label warnings to advise closer monitoring of suicidal behavior.
The agency suggested physicians and family members more closely watch children and adults taking such antidepressants as Prozac, Zoloft and Paxil for suicidal tendencies, especially at the beginning of treatment or when a dosage is changed.
The manufacturers were told to strengthen warning language already included on the drugs’ information labels.
The FDA also included Luvox, Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron in its warning.
After the advisory was issued, pharmaceutical companies pledged to work with the government to develop new warning language.
“We agree with the FDA that all patients suffering from depression should be closely monitored,” said Shreya Prudlo, a spokeswoman for Pfizer, which manufactures Zoloft. “We remain committed to working with the FDA to ensure that we have the best label for physicians.”
The announcement could have a dramatic impact on the pharmaceutical industry and patients with depression, but the effects are not clear yet. The antidepressant class of drugs, with about $10 billion in annual U.S. sales, is the third largest selling group with an estimated 20 million Americans taking them.
Several local and national psychiatrists said it is critical that people taking antidepressants continue doing so until speaking with a physician.
“This is sure to generate a lot of anxiety,” said Dr. Andrew Harper, chief of child and adolescent services at the Harris County Psychiatric Center, a facility of the University of Texas Health Science Center at Houston. “But I don’t think this data is sufficient to warrant discontinuing medication. Before making any change, patients should consult their physician, and they shouldn’t be shy about discussing their concerns.”
Patients who suddenly halt their medication can suffer a relapse, doctors said, increasing the chances of suicide.
The announcement should be good news for people like Ron Dusek, who believes his father committed suicide after taking Zoloft. Dusek has filed a lawsuit against Pfizer, the manufacturer of the market-leading drug, in a federal court in Houston.
Cyril Dusek, 77, was taking a drug for emphysema that made him feel itchy, so doctors prescribed Zoloft for the symptoms, his son said. A few months later, in February 2000, the breathing problems were gone, but Cyril Dusek had grown increasingly nervous, his son said. He continued to take the antidepressant.
A longtime newspaper reader and TV news watcher, Cyril Dusek abandoned these habits, saying they depressed him. He didn’t want to talk to anyone — gone were morning and afternoon klatches at a coffee shop in Schulenburg with buddies.
“He was just too nervous and too agitated,” Ron Dusek, 55, said. “The things that he enjoyed doing before depressed him. He was a changed person. Everybody was commenting that he was not the person everybody knew.”
Doctors increased the medication. Then Cyril, a Catholic who was, his son said, happily married for 53 years and healthy, tore his rosary into pieces. A few days later he shot himself.
The FDA advisory is a recognition of concerns, first raised with scientific evidence last year in studies of children taking antidepressants that appeared to suggest an increased risk of suicidal thoughts.
In February several dozen people, telling stories about their children who had committed suicide shortly after starting to take the drugs, plaintively asked the FDA to change its view toward antidepressants in sometimes anguishing testimony.
Andy Vickery, a Houston trial lawyer who specializes in cases against antidepressant manufacturers and represents Dusek, testified at the hearing.
“I’ll say three things,” Vickery said of the new advisory. “I’m glad, I’m mad and I’m sad.”
Vickery said he is glad about the ruling, mad that it took so long and sad that people have suffered because of the drugs.
Both in courtrooms and clinical trials, it is exceedingly difficult to determine whether depression ultimately causes a suicide or if medication contributes in some way, experts say.
The newest and now dominant class of antidepressants, selective serotonin reuptake inhibitors, work to restore a healthier balance of the chemical serotonin in the brain.
Although these SSRI drugs have side effects such as sexual problems, headaches or agitation, their introduction in the late 1980s has lowered the overall suicide rate, said Dr. Eric Hollander, a psychiatrist at Mount Sinai School of Medicine in New York.
Part of the problem now may be the increasingly wide prescription of these psychiatric drugs by general practitioners. More than half of antidepressants are now prescribed by these doctors rather than psychiatrists, Hollander said.
A family doctor screening for depression may not recognize bipolar disorder and prescribe an SSRI drug, which might exacerbate the problem, when a mood-stabilizing drug is the normal treatment, psychiatrists say.
In addition to changing the labeling of the 10 antidepressants, the FDA, acknowledging a lack of “clarity,” said it will begin a comprehensive review of all data available using standard, unbiased methods. The agency plans to provide an update on its progress later this summer.
Since nearly all of the hundreds of lawsuits filed against antidepressant manufacturers have been unsuccessful, the FDA ruling is a welcome boost for Dusek and others who are seeking remedy in the courts.
Lawyer Vickery, however, already has had one key victory. In 2001, Donald Schell, a 60-year-old taking Paxil, killed his wife, daughter, grandaughter and himself. A federal jury in Wyoming awarded relatives of the family $6.4 million, finding that the drug could cause a person to become homicidal or suicidal.
The lawyer said he believes the FDA has finally bowed to intense public pressure on the potentially suici
dal effects of antidepressants but is concerned that, in an election year, the effect may only be temporary.
“How long will it continue? Heaven knows,” he said. “I’m always fairly skeptical.”

Copyright 2004