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Wellbutrin use comes with warning

Feb 12, 2006 | The Olympian

Wellbutrin is one of several antidepressants that the U.S. Food and Drug Administration announced in 2004 could increase the risk of suicidal thoughts or behaviors in children or adolescents being treated for depression.

The agency required a “black box” warning for all antidepressants issued after October 2004. A similar warning followed for adults last year, although the FDA said it needs more time to study the clinical trials to ensure there is as high a risk as with adolescents.

In the meantime, the FDA has cautioned that adults on antidepressants should be monitored closely for any behavioral changes, especially when they start taking the drug or receive dosage changes.

Wellbutrin, manufactured by GlaxoSmithKline, works by correcting an imbalance in the brain of dopamine, one of several chemicals thought to be involved in depression.

The most common side effects reported are nausea, blurred vision, dizziness and headaches. It also has been associated with increased risks of seizures in some patients.

But unlike another class of antidepressants known as SSRIs, Wellbutrin seems to carry less risk of sexual side effects, which makes it especially appealing to adults.

The FDA advisory followed warnings for years from some researchers and consumer advocates about the potential dangers of antidepressants. In numerous cases around the country, attorneys and some health professionals have argued that there’s a link between suicides or horrific crimes and people who recently had been prescribed an antidepressant.

Others, however, say the drugs are highly effective and allow depressed patients to retake control of their lives, and that those benefits outweigh the risks to a small percentage of patients.

A study published in the American Journal of Psychiatry in January in response to Food and Drug Administration warnings looked at suicide rates among 65,000 Group Health Cooperative patients who had been treated with antidepressants.

It found a much higher risk among adolescents on medication than those taking a placebo. For adults, the study found that the risk increased during the first month of medication, but that it still was lower than the risk during the month before getting treatment.

Once outside the initial treatment phase, the rate of suicidal behavior dramatically decreases for everybody, the study found.

Depressed patients often come in at a peak in their distress, which makes it difficult to say that the medication triggered suicidal tendencies, said Wayne Katon, a psychiatry professor at the University of Washington. He noted that elderly men are 10 times more likely to commit suicide than adults under age 60, especially those with depression or chronic illness.

But side effects, especially during the first few weeks or whenever a dosage is altered, can exacerbate symptoms of depression.

That’s why it’s critical for doctors to follow up with their patients in one to two weeks.

“There are a lot of people with a depression or anxiety disorder who need antidepressants who are not getting good management,” he said. “The public has something to do with that.

“People come in wanting a pill. Americans are always looking for short-term fixes, like the latte to wake up today. A part of this is because it’s part of our society.”

Doctors also need to do a better job of educating patients about side effects and their disorders.

“In general, the FDA warning was to make sure patients get closer follow-up, which is something we’ve always recommended,” Katon said.

Each patient reacts differently to medications.

About 15 percent of patients experience side effects that force them to stop taking the medication, while another 10 to 15 percent have bothersome side effects that eventually subside, he said.

An elderly patient, for example, probably should start on a dosage lower than the standard because he or she might not metabolize the drug as well, he said.

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