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Archive for Tuesday, March 23, 2004

FDA warns of suicide, antidepressant link

Doctors urged to keep an eye on patients’ behavior

March 23, 2004

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— Patients taking certain antidepressant medicines should be carefully monitored for suicidal thinking, increased depression and other symptoms such as hostility and agitation, the federal government advised Monday.

The public health advisory, issued by the Food and Drug Administration, asks makers of 10 antidepressants to include on their products' labels a warning that urges careful observation of adult and child patients who take the drugs.

"We are not saying not to take these products," FDA spokesman Jason Brodsky said. "We're saying we want patients to be aware of the benefits and the risks, and if they notice any of the symptoms or signs described in the advisory, to notify their physician."

Drugs covered in the warning are the brand-name Prozac (generically known as fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine).

Some of the drugs are approved to treat ills besides depression, such as post-traumatic stress and panic disorders. Only fluoxetine is approved for depression in children.

Some experts worried that the FDA warning would unduly stigmatize the drugs or alarm patients, causing them to avoid or discontinue needed treatment.

"For instance, someone who has been on medication that has been helpful may get scared; parents may feel uneasy about taking their children for evaluation or treatment, fearing it will make them worse," said Dr. Marcia Goin, president of the American Psychiatric Assn.

A chief concern is the lethality of depression itself. About 2 percent of people treated for depression in an outpatient setting, and 4 percent who've been admitted to a hospital for depression, will die by suicide, research suggests.

The FDA action Monday represents an elevating of the level of concern from the "precautions" part of a medicine label to the weightier "warning" section, Brodsky said.

The FDA called for warning information to urge that doctors:

  • Monitor patients using these antidepressants for possible worsening of depression symptoms or suicidal thoughts or behavior, especially when the drug therapy is begun or when doses are adjusted.
  • Evaluate patients whose depression continues to worsen, or suicidal tendency emerges quickly or severely, to consider what action to take next.
  • Be vigilant for symptoms including anxiety, agitation, restlessness, panic attacks, irritability, hostility, impulsiveness and mania.
  • Taper patients off the drugs gradually if they are discontinued.
  • Screen patients thoroughly for bipolar disorder, also known as manic-depression. Antidepressants may induce episodes of mania in such patients.
  • Alert patients and their families and caregivers to watch for problematic symptoms and to report them immediately to the doctor.

Depression was diagnosed in 21.1 million patient visits to U.S. doctors last year, making it the sixth-most-common diagnosis, according to IMS Health, a company that tracks the drug industry. And primary care doctors provide an estimated four in 10 antidepressant prescriptions, other research shows.

Goin said primary care doctors might not be as aware as psychiatrists of the delicate process of treating severe depression. Psychiatrists have noted for years that, early in depression treatment, the medicines may help restore patients' depleted energy levels before diminishing any suicidal thoughts they might have, she said.

"They then have the energy to do that which they have been contemplating," Goin said.

For more about the Food and Drug Administration's health advisory an antidepressants, see ,a href="http://www.fda.gov/cder/drug/antidepressants/default.htm" target="_blank">www.fda.gov/cder/drug/antidepressants/default.htm.

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