Prozac®
Manufacturer:
Eli Lilly
Uses: Antidepressant
More Information
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| Prozac |
New evidence has surfaced showing that Eli Lilly & Co. knew Prozac was linked
to suicidal behavior and violence as early as 1988. Confidential Eli Lilly & Co.
documents obtained by the British Medical Journal suggest that the company was
aware that its antidepressant Prozac was linked to troubling side effects as far
back as 1988, the same year the drug was introduced to the U.S. market.
The discovery was reported in the January 1, 2005 issue of the British
Medical Journal. The papers have been turned over to the U.S. Food and Drug
Administration. Amid the pile of internal reviews and memos, according to the
journal, is a document dated November 1988 that reports Prozac (fluoxetine) had
caused behavioral problems, including agitation and panic attacks, in clinical
trials.
Prozac, the only antidepressant certified as safe for children, may make kids
more suicidal, according to new evidence. A large new study added to previous
research on Prozac shows that kids taking the drug have about a 50 percent
higher risk of suicidal thoughts and suicide attempts, says Robert Temple,
director of the Office of Drug Evaluation at the Food and Drug Administration.
Temple spoke at the first day of hearings on potential label changes for
antidepressants taken by more than a million children and teenagers. Following a
February hearing, the FDA in March asked drug companies to relabel 10
antidepressants, warning that young patients should be watched for worsening
depression and anxiety. Critics at the time derided that move as "too little,
too late," considering that, in December, British drug regulators had advised
doctors to prescribe only Prozac for depressed kids. Other major antidepressants
prescribed for kids already have been found to raise the risk of suicidal
behavior. Prozac had been an exception. "What's interesting and persuasive is
that these studies now all lean the same way," Temple says.
Dozens of parents testified at the hearing that antidepressants had caused
their children to kill themselves or others. Their claims were "passionate and
plausible," says psychiatrist Wayne Goodman, chairman of the FDA advisory panel.
On average, antidepressants taken by kids will cause an extra 2 percent to 3
percent to have increased suicidal thoughts, the independent experts, working
with Columbia University, found.
Relative risks of suicidal behavior were highest among youths taking Luvox,
Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac. Two
FDA advisory panels are considering whether agency action including stronger
warning labels is needed on nine antidepressants linked to heightened suicidal
tendencies among children.
Side Effects
- Rash
- Headache
- Tremor
- Dizziness
- Asthenia
- Insomnia
- Anxiety
- Nervousness
- Agitation
- Abnormal dreams
- Drowsiness and fatigue
- Excessive sweating
- Nausea
- Disturbances of appetite
- Diarrhea
- Bronchitis
- Rhinitis
- Weight loss
- Muscle, Back and Joint pain.
- Painful menstruation
- Sexual dysfunction
- Urinary tract infection
- Frequent urination
- Chills
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