The document also suggests that the company attempted to minimize public awareness of the side effects.
The document, made public Monday, Jan. 03/2005 was provided to CNN by the office of Rep. Maurice Hinchey, D-N.Y., who has called for tightening FDA regulations on drug safety.
The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants.
The document, which cited clinical trials of 14,198 patients on fluoxetine the generic name for Prozac also stated that 2.3 percent of users suffered psychotic depression while on the drug, more than double the next-highest rate of patients using another antidepressant.
In addition, the paper said that 1.6 percent of patients reported incidents of hostility more than double the rate reported by patients on any of four other commonly used antidepressants.
The trials reviewed in the document said that 0.8 percent of users of Prozac reported causing an intentional injury, eight times the rate associated with any of the other antidepressants.
In the paper, titled "Activation and sedation in fluoxetine clinical trials," the authors said that the drug may produce nervousness, anxiety, agitation or insomnia in 19 percent of patients, and sedation in 13 percent of patients.
The existence of the document obtained by CNN and other documents was reported last week by the British Medical Journal. Its editors said the documents had been reported missing from a 10-year-old murder case, and that they had sent them to the Food and Drug Administration for review.
In a long-awaited move, in January 2005 the FDA approved the language for so-called black-box warnings on antidepressants.
The action came four months after a government panel determined the medicines were linked to suicide in youngsters. As a result, the panel recommended drug makers add the warnings in order to alert doctors to the serious side effects.
The recommendation followed 18 months of controversy over the medicines. The episode cast a harsh spotlight on the pharmaceutical industry after it became known that some drug makers failed to disclose links between their antidepressants and suicide.
A black-box warning is the most severe warning that can be issued about a prescription drug. The information is prominently placed on package inserts and in physician reference manuals that are read by doctors nationwide.
The warning was to be added to several widely prescribed drugs, including Effexor, Zoloft, Paxil and Prozac. Only Prozac was approved for children, but doctors are free to prescribe any medication for patients, which explained widespread usage of many pills.
In a letter to drug makers, the FDA wrote in January 2005 that final labeling should be on company Web sites within two weeks and on all products within 30 days, according to the Pink Sheet, an industry publication. A medication guide was also supposed to be available by Jan. 31.
Flash forward to February, 2005...
The Washington Post reports on Feb. 21, 2005:
"Adults taking popular antidepressants such as Prozac, Paxil and Zoloft are more than twice as likely to attempt suicide as patients given placebos, according to an analysis of hundreds of clinical trials involving tens of thousands of patients.
The results, published last week in the British Medical Journal, mirror a recent finding of the Food and Drug Administration that the drugs increase suicidal thoughts and behavior among some children and offer support to concerns going back 15 years that the mood-lifting pills have a dark side.
The examination of 702 controlled clinical trials involving 87,650 patients is the most comprehensive look at the subject and is particularly telling because it counted suicide attempts and included patients treated for a variety of conditions, including sexual dysfunction, bulimia, panic disorder and depression."
Since the arrival of Prozac in 1988, these drugs have transformed psychiatry in the United States, even as persistent critics have warned that their benefits were hyped and their risks ignored. A spate of lawsuits in recent years have claimed that the drugs were responsible for violent and suicidal behavior.
Flash forward to March 31, 2005...
Newstarget reports, "The very first week you start taking antidepressant drugs, your risk of committing suicide quadruples. Antidepressants have long been accused of actually causing suicides and violent behavior, and now research is proving it."
Their article cites specific headlines that hit the front pages in many cities, including:
"Don't forget that the high school students who went on a shooting rampage in Colombine were on antidepressant drugs. So was Phil Hartman's wife when she murdered the actor. Time and time again, the most outrageous acts of violence in our nation are frequently linked to people who use SSRIs (antidepressant drugs)."
The New York Times reports, "The year-long debate over whether antidepressant drugs increase the risk of suicide in some children may soon widen to include adults, as English and Canadian scientists are reporting findings from three new analyses of suicide risk in people over age 18 who have taken the medications."
The story on Prozac is not going away...
If anything, it's building in momentum as more and more clinical trials come to light, and further documents are made public.
Here's what really puzzles me about this picture.
We have a 100% juice product that is made from a berry well known to have a major side effect --- it makes people happy. Safe for children, adults, seniors, diabetics, even pregnant women... It's a natural, whole food, unpasteurized and nutritionally dense product that does far more for your health than simply make you feel good.
Then on the other side of the coin, you have a pill that's "supposed" to make you happy --- yet, according to many of the recent reports and clinical studies flying in, it comes with extremely dangerous side effects for some users.
Yet millions (yes, I said millions) would rather pop a potentially dangerous pill.
Do you see something wrong with this picture, too?
Sources:
NewsTarget March 31, 2005 - Antidepressant drugs quadruple risk of suicides, research shows
Washington Post Feb. 21, 2005 - Study Ties Antidepressants To Suicide
New York Times Feb. 18, 2005 - Antidepressant Safety Debate May Include Adult Patients
Star Ledger Jan. 14, 2005 - FDA Approves Antidepressant Warning Language
CNN Jan. 4, 2005 - Document May Reveal Prozac Risk
ParmExec Jan. 4, 2005 - BMJ TURNS OVER MISSING PROZAC DOCUMENTS TO FDA; LILLY DENIES ANY MISSING DOCUMENTS
