FDA Warns that Paxil Makes Depressed Adults Suicidal

By Peter R. Breggin, M.D.


Getting the FDA to move forward by presenting it with scientific data is like using a peacock feather to tickle a sleeping giant tortoise on its shell.  Many people die before the agency opens its eyes and then it barely reacts at all.



The FDA Confirms Antidepressant-Induced Suicidality in Adults


So, after years of prodding by me and more lately by a handful of other professionals, what new point in its journey has the FDA tortoise reached? In a May 2006 release in collaboration with the manufacturer GlaxoSmithKline (GSK), the FDA has acknowledged the antidepressant Paxil causes a statistically significant increased rate of suicidality in depressed adults as measured in controlled clinical trials. [1] The results are based on a re-analysis of all adult controlled clinical trials that compared Paxil with placebo. 

No other antidepressants were mentioned in the FDA’s warning but all SSRI antidepressants share a common profile of adverse mental and behavioral effects, including Paxil, Prozac, Zoloft, Celexa, Luvox, and Lexapro.  Several other relatively new antidepressants have also been implicated in producing similar psychiatric abnormalities, including Wellbutrin, Effexor, Serzone, and Cymbalta.  All of the newer antidepressants can produce stimulation or activation with the potential for increased agitation, anxiety, mood instability, disinhibition, irritability, aggression, hostility, mania, and crashing into depression and suicide.  They can also cause a flattening of emotional responses, including a loss of caring, that can unleash dangerous actions.



http://www.breggin.com/).  I based my observations on suppressed company data that I had discovered during a three-day investigation inside the drug company’s secret files, working as a medical expert in a murder-suicide product liability case against the company.

The Struggle to Enlighten the Public, the Profession and the FDA



Continued Obfuscation


The FDA allowed the Paxil manufacturer to soft pedal the results by claiming, for example, that the results could be compounded by the fact that suicide is an aspect of “psychiatric illnesses.” This is nonsense—and every scientist knows it. Since both groups were depressed, and since they differed only in the substances they were given to take, Paxil and not depression was the cause of this astronomical increase in suicidality.



The Real-Life Risk Is Much Greater than Described


It’s nothing short of a miracle that GSK-sponsored clinical trials have demonstrated the increased risk of suicidality from antidepressants.  If not a miracle, it’s a confirmation that the risk is enormous—far more so than indicated by the studies.  Keep in mind that controlled clinical trials are planned by the drug companies, supervised by the drug companies, and carried out by paid lackeys of the drug companies.  Keep in mind that all the data analysis is done at drug company headquarters by drug company execs.  Keep in mind that the trials are constructed in order to prove the usefulness of the drug and to minimize its adverse effects such as suicidality.  Keep in mind that the controlled clinical trials are very short, usually 4-6 weeks long, and that prescreening excludes suicidal and psychotic patients from participating in the studies. 

If Paxil increased the rate of suicidality by more than six times in the drug company’s controlled clinical trials, it may be doing so by sixty times in actual practice.  We can’t determine exactly how much greater the risk will be in clinical practice but it will be astronomically greater.  



And the Antidepressants Don’t Even Work


Meanwhile, a comprehensive review of all studies of antidepressant drugs submitted for approval to the FDA showed that when the studies are taken as a whole, antidepressants don’t work. [7] A drug company may perform twenty studies in an attempt to show efficacy Exemplified by the case of Prozac, as I described in Talking Back to Prozac (1994), as long as two studies show a positive effective, the FDA will approve the drug. If a drug company cannot massage their self-generated data sufficiently to obtain a positive result in two out of twenty clinical trials, the company’s paid consultants and employees don’t deserve to stay employed. And of course, they won’t stay employed if they fail to meet the company’s needs to promote new products.



Of course, many people feel helped by antidepressants, as well as by many other psychiatric and even psychoactive drugs.   The placebo effect is enormous.  In addition, the artificial euphoria or emotional flattening produced at times by antidepressants may provide temporary relief at the cost of rationality or effective dealing with life.



It’s time to say again what I’ve been saying for too many years on end.  The antidepressants aren’t antidepressants.  They are more likely to make a person worse than better.   More tragically, these toxic agents push may people over the brink into suicide and violence.




Meanwhile, the antidepressants are very difficult to stop taking.   Withdrawal from antidepressants can lead to “crashing,” with agitation, violence and suicide.   Withdrawal from these noxious drugs should be done slowly with experienced clinical supervision. These drugs are not only unsafe to start—they are dangerous to stop. The best approach to antidepressants: Don’t start taking them.