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Millions of patients taking popular antidepressants need close watching for the warning signs of suicide or other serious mental health problems, especially when the powerful drugs are first started or their dosage is changed, federal health officials cautioned Monday.
The advisory from the Food and Drug Administration does not tell people to stop taking medications such as Prozac, Paxil, Wellbutrin and Zoloft. Nor does it say antidepressants can lead to suicide. Federal regulators are awaiting more research before reaching any conclusions on whether the drugs give rise to suicidal feelings or actions.
Instead, FDA officials urged patients, doctors and other caregivers to watch for any unusual reactions to the medications. Patients who show warning signs such as talking about suicide or abruptly withdrawing from activities and loved ones should get prompt medical help, even if they are already being treated for depression. Makers of the drugs are also being asked to step up suicide warnings on package labels.
The FDA warnings will affect millions of Americans of all ages. Newer types of antidepressants were the third most commonly prescribed class of drug in 2003, pulling in $10.9 billion for their makers. Their use is growing in adults and children alike.
The 10 medications covered by the warning include Prozac and its generic forms, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron. They are most commonly prescribed for depression, but some may be used to treat other conditions such as panic or obsessive-compulsive disorders.
Almost 180 million prescriptions for antidepressants were handed out in 2001, according to drug research firm IMS Health. But popularity doesn’t make a medicine risk-free.
The FDA’s action comes as questions about a link between antidepressants and suicidal feelings have grown, particularly in children and teenagers. The FDA has been reviewing a growing body of research into antidepressants and pediatric suicide, and health officials in Great Britain last year declared some newer antidepressants to be unsuitable for young people.
Doctors said the FDA warning offers a good reminder that antidepressants are powerful and often unpredictable.
“I think the recommendation is very reasonable,” said Dr. Glen Elliott, director of the children’s division of Langley Porter Psychiatric Institute at the University of California-San Francisco. “These are potent medications.”
Suicidal feelings often accompany the very depression that makes such drugs appealing. But the FDA urged doctors and patients to pay closer attention, regardless of possible cause. Signs of increased anxiety, hostility or other conditions should also be noted and reported to a physician.
Many people respond well to antidepressants. But some may not work in a particular person, or trigger a wide range of side effects.
“It’s really a trial-and-error process,” said Tom Rimel, who started taking antidepressants alongside other patients at a Silicon Valley care center for people shedding dependency on alcohol and drugs. “Being around so many people taking the drugs, you could really see the range of side effects and how many of the drugs didn’t work.”
Rimel, 47, was diagnosed with depression at the center run by Kaiser Permanente and started taking Paxil in December 2001. In addition to meetings and classes, he got regular checkups from doctors and case workers.
That kind of attention meant his use of antidepressants got careful monitoring, he said. Paxil worked well for him for about a year but after developing liver problems, Rimel switched antidepressants.
“You need to have follow-up with the doctor and be on top of your symptoms,” Rimel said. “If the drug is not working, you need to speak up.”
Doctors said the most intensive monitoring is needed when someone first starts the drugs or has the dosage or medication changed. Antidepressants often take two to four weeks to work fully.
Someone who has been immobilized by depression may start to have more energy as the drugs kick in. But they may also still have depressed or suicidal thoughts — and suddenly more of an ability to act on them.
“Those are the dangerous times,” Elliott said. “Someone may actually find they have the energy to act on suicidal impulses. You can’t stop monitoring patients.”
Patients who notice any unusual effects from the drugs or have questions about their use should not abruptly stop taking them, FDA officials stressed. Doing so can be dangerous, and patients should talk with their doctor.
“It’s very good to be aware,” said Dr. Tiffany Ho, medical director of the Santa Clara County Health Department. “But people shouldn’t be overly alarmed. These medications have helped millions of people.”