Headlines
As reported by the Danbury News-Times, March 23, 2004.
Drugs for Depression Win Support Despite Warnings
By Robert Miller
A U.S. Food and Drug Administration warning about antidepressants doesn’t mean people suffering from depression shouldn’t take them, area psychiatrists said — only that the drugs should not be misused or taken imprudently.
On Monday, the FDA asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels.
"They should not be prescribed in a cavalier manner,” Dr. Orestes Arcuni, chairman of psychiatry at Danbury Hospital, said Monday. "But it would be a shame if they were withdrawn. They’ve helped millions of people.”
"People get alarmed when they hear these things,” said Dr. Lisa Diamond, director of psychiatry at New Milford Hospital. "But I have no concern about prescribing these drugs at all. I’ve used them for years.”
The warning involves the class of antidepressants called selective seratonin reuptake inhibitors, or SSRIs. These include drugs such as Prozac, Zoloft, Wellbutrin and Paxil, that have significantly changed the way doctors treat clinical depression.
In recent years, patients and their families have begun claiming the drugs — instead of helping — pushed patients into suicide or suicidal behavior.
The FDA is investigating claims children on these antidepressants suffered a high number of adverse reactions to the drugs, especially Paxil. A study on the claims is expected to be completed in September. Only Prozac has FDA approval for treating childhood depression.
But on Monday, the FDA put out a general warning for Celexa, Effexor, Lexapro, Luvox, Paxil, Prozac, Remeron, Serzone, Wellbutrin and Zoloft.
The FDA’s warning asked the manufacturers of these drugs to rewrite their packaging and warning labels to emphasize the drugs can cause severe side effects, including restlessness, agitation, irritability, insomnia and panic attacks. The FDA advises patients, their family members and their physicians to closely monitor for these side effects, especially when patients begin taking the drugs, or when they increase or decrease dosages.
The FDA said "it is not yet clear” whether these drugs also "contribute to the emergence of suicidal thinking and behavior.”
But Dr. Russell Katz, director of the FDA’s neuropharmocological division, said "it’s just good advice to pay attention” to the side effects, no matter what the outcome of FDA’s review this fall.
"People should know about this,” he said.
Serotonin is a neurotransmitter that helps nerves carry messages. People suffering from depression have low levels of the chemical. SSRIs work by correcting the effects of serotonin deficiency.
Dr. Nicholas DeMartinis, an associate professor of medicine in the psychiatry department of the University of Connecticut School of Medicine in Farmington, said some SSRIs stimulate serotonin reception throughout the brain, causing restlessness and insomnia in a few patients — especially in the first two weeks of treatment. The newest drugs in this line, he said, are better at acting only on certain nerve receptors.
He said people suffering from bipolar disorder — what used to be called manic-depression — are especially prone to side effects from these drugs. The problem, DeMartinis said, is when bipolar patients are on the high ends of the mental cycles, they don’t think they need any medication. On the low end, they may not tell their doctor about the high swings. As a result, they get treated for depression with SSRIs.
Arcuni said these drugs also aren’t useful in treating attention disorder syndromes. If young people take SSRIs, then use recreational drugs, the drugs can interact, accentuating problems, he said.
And, DeMartinis said, some people suffer from such a profound depression that they literally don’t have the energy to commit suicide. Getting on SSRIs can give them a burst of energy. Unfortunately, that energy may be directed toward suicidal tendencies.
The psychiatrists said many people go to their family doctor for depression and get SSRI prescriptions. That’s not a bad thing, Diamond said. If people need help, they should get it. But family doctors may not be fully up-to-speed about all the elements of psychiatric illnesses or be aware of the side-effects of these drugs.
For example, Diamond said, to be able to differentiate between depression and bipolar disorder, "you need to do a very, very clear history-taking. You need to know what questions to ask.” If patients suffer side-effects from the drugs, she said, doctors have to know to reduce the dosage or switch to a second drug.
Arcuni also said many people think they need antidepressants when they don’t — they’re simply suffering from the normal ups and downs of life. Taking SSRIs won’t help them, and may cause problems.
"I think they’re being over-used and improperly used,” he said.
But for those who suffer from clinical depression, SSRIs can be godsends.
"‘Life-saving’ is a good term,” Arcuni said.
DeMartinis said people should also realize that not getting help for depression puts people in harm’s way far more than the occasional, usually manageable side-effect.
"Ten to 15 percent of people suffering from depression commit suicide, and that’s much higher than the 1 percent of the patients who take these drugs and report ‘suicidal behaviors,’” he said. Because only about half the people suffering from depression get help for it, he said doctors need to be more aggressive about treating it.
The key, Arcuni said, is simply for doctors to be very knowledgeable about these illnesses and the drugs available, and to monitor their patients very closely.
"It should preferentially be done by a psychiatrist, even on a consulting basis,” he said.
In this context, the FDA warning is useful, as long as people realize the FDA is not telling people to stop taking antidepressants.
"Physicians can help educate patients and their families about these side-effects and what to look for,” DeMartinis said. "But the real message should be: ‘Don’t avoid these drugs.’”