Prozac, Wellbutrin, Paxil, Effexor and Zoloft

Antidepressants Get FDA Warning


Agency’s Recommendations on Suicide Risk Include Adults as Well as Children

March 23, 2004; Page D1

The Food and Drug Administration sharply stepped up warnings about possible risks to patients taking antidepressant drugs, asking doctors, families and caregivers to watch closely for signs of increasing depression or suicidal thinking.

The FDA asked the makers of 10 major antidepressant drugs, including versions of Prozac, Wellbutrin, Paxil, Effexor and Zoloft, to place more detailed, explicit warnings on the labels for their medicines. The FDA didn’t order the manufacturers to change their labels, but urged them to do so voluntarily. The new cautions would ask doctors to monitor patients for a variety of symptoms from insomnia and irritability to hostility and panic attacks that might possibly signal greater risks.

The announcement comes more than a month after an FDA advisory committee urged the agency to provide clearer warnings about possible risk of suicidal tendencies in children and adolescents taking antidepressants. Still, yesterday’s development went well beyond the earlier recommendations, and included adults as well.

The most immediate result may be that doctors, particularly those who don’t focus on pediatric psychiatry, become more cautious in how they prescribe antidepressants for kids and teenagers. They could start prescribing smaller doses and being slower to step up the amounts of medicine.

“People might wait until they’ve been in talking therapy a little bit, before trying drugs,” said Richard Malone, a child psychiatrist at Drexel University College of Medicine, who was a member of the FDA advisory committee.

4 replies
  1. Paxil Prescription Information says:

    My name is Michael Smith and i would like to show you my personal experience with Paxil.

    I am 40 years old. Have been on Paxil for 5 years now. Please be careful if coming off, i started to wean myself with out doctors help couldnt afford it. I went from 20 mgs to 10 mgs for a month, then 10 mgs to 5 mgs for a month. Because the 20 mgs were way to strong took 20 for 5 years and was always on edge. After about 1 month on 10 felt a little better. I stopped for 7 days completly and man did I feel like shit man I didn’t want to leave the house , shop! I just started back on 5 mgs to get it back in my system. Who know what is the right amount you have to be the test subject on yourself!

    I have experienced some of these side effects-
    Headaches, tremors, emotional wreck, just the blah’s when I 1st started takin wasnt bad, cause I also way taken klonopin.

    I hope this information will be useful to others,
    Michael Smith

  2. and? says:

    Kia Ora!

    My name is Laura, i am 16 years old and i have seen what Prozac can do to people… and it isn’t pretty!

    On the 20th of March 2008 a friend of mine, Toran Henry was on Prozac, he hung himself in his garage. The person that prescribed Toran the prozac never warned him, nor his mother of the risks that prozac had. The person who prescribed him the Prozac even told Toran that he could stop Prozac on the weekends and drink alcohol with his friends. His death has devastated so many people. His mother organized a march up Auckland’s main street and a rally. So many people turned up and i had the chance to talk to a lady who lost her brother while he was on Prozac.

    At the end of last year, another friend of mine, Jess, who was also on Prozac jumped out in-front of a car. It was revealed that she took an overdose of prozac… and the same thing happened with her and her parents… they were never warned of the risks that Prozac had!

    Loosing 2 friends sucks… but what sucks more is that it seems as if nothing is happening to warn people of the risks. In no way am i suggesting not to use these prescribed drugs, but i am saying that people NEED to be informed of the risks that Prozac has.

    PLEASE ask for the risks that come with whatever drug you are taking… hopefully it can save someone’s life next time!

  3. caleb says:

    Given the upsurge of Zoloft birth defects that we’ve been seeing even just in the last couple of years I can’t help but think that FDA should have made this announcement a LONG time ago.  You don’t need pictures to see just how many children are doomed to a disabled life, or worse even, die at a young age due to holes in their heart or mismatched veins.  Surgery can’t fix everything, unfortunately :(

  4. caleb says:

    Given the upsurge of Zoloft birth defects we’ve been seeing in the last five years or so, you’d think FDA would have acted so much faster, they never should have allowed doctors to prescribe this drug to expectant mothers in the first place. Countless deformities, life expectancy-shortening defects, holes in hearts, cleft lips and palates… all these are things both the FDA, (and Pfizer) are responsible to.

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