SSRI RISK GREATER THAN BENEFIT: New Systematic Review of Research – SSRIs vs Placebo

Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

Published February 8, 2017:

” We have clearly shown that SSRI significantly increase the risks of both serious and several non-serious adverse events. The observed harmful effects seem to outweigh the potential small beneficial clinical effects of SSRI, if they exist.

Conclusions

SSRIs versus placebo seem to have statistically significant effects on depressive symptoms, but the clinical significance of these effects seems questionable and all trials were at high risk of bias. Furthermore, SSRIs versus placebo significantly increase the risk of both serious and non-serious adverse events. Our results show that the harmful effects of SSRIs versus placebo for major depressive disorder seem to outweigh any potentially small beneficial effects.

Brief Overview of the Study

Highlights of the study bolded and with added emphasis:

Background

The evidence on selective serotonin reuptake inhibitors (SSRIs) for major depressive disorder is unclear.

Methods

Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo, ‘active’ placebo, or no intervention in adult participants with major depressive disorder. We searched for eligible randomised clinical trials in The Cochrane Library’s CENTRAL, PubMed, EMBASE, PsycLIT, PsycINFO, Science Citation Index Expanded, clinical trial registers of Europe and USA, websites of pharmaceutical companies, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency until January 2016. All data were extracted by at least two independent investigators. We used Cochrane systematic review methodology, Trial Sequential Analysis, and calculation of Bayes factor. An eight-step procedure was followed to assess if thresholds for statistical and clinical significance were crossed. Primary outcomes were reduction of depressive symptoms, remission, and adverse events. Secondary outcomes were suicides, suicide attempts, suicide ideation, and quality of life.

Results

A total of 131 randomised placebo-controlled trials enrolling a total of 27,422 participants were included. None of the trials used ‘active’ placebo or no intervention as control intervention. All trials had high risk of bias. … SSRIs significantly increased the risks of serious adverse events…. This corresponds to 31/1000 SSRI participants will experience a serious adverse event compared with 22/1000 control participants. SSRIs also significantly increased the number of non-serious adverse events. There were almost no data on suicidal behaviour, quality of life, and long-term effects.

Conclusions

SSRIs might have statistically significant effects on depressive symptoms, but all trials were at high risk of bias and the clinical significance seems questionable. SSRIs significantly increase the risk of both serious and non-serious adverse events. The potential small beneficial effects seem to be outweighed by harmful effects.

Link to full study: http://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-016-1173-2

 

As Patents Expire Truth Begins to Surface

As I pointed out first in the 1994 issue of my text on antidepressants, “Prozac: Panacea or Pandora?,” the truth about the adverse effects of medications generally do not surface until the expiration of patents on these drugs – the time that the income on these drugs drastically drops as the majority of drugs in a group of drugs begins to go generic. Are we finally beginning to see that after years of warning of these deadly side effects? If so it is time to really begin warning about the deadly effects of withdrawal done too rapidly. We could be facing a nightmare of people wanting to withdraw from these drugs when most doctors know so very little about safe withdrawal from antidepressants.

PLEASE let people know to wean extremely gradually down off these drugs! For two decades the warning above has been at the top of our website warning of abrupt or rapid withdrawal. The body and brain need time to readjust after so many chemical changes!

Keep in mind the case of Traci Johnson, the young healthy volunteer (no depression), who took the antidepressant Cymbalta for 20 days and then after a withdrawal period of only four days hung herself in the laboratory for Eli Lilly, the manufacturer. After that tragedy and subsequent wrongful death suit Eli Lilly changed their time period for withdrawal in their clinical trials by double! So after 20 days on they began taking 8 days to wean off – almost the exact amount of time we have found over the years is a safe period of time to withdraw without serious reactions is about half the amount of time on the drug.

Posted in Recent Cases Blog.

Ann Blake-Tracy

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
(DrugAwareness.Org & SSRIstories.Net)
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

She has specialized since 1990 in adverse reactions to serotonergic medications (such as Prozac, Sarafem, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Serzone, Remeron, Anafranil, Fen-Phen, Redux and Meridia as well as the new atypical antipsychotics Zyprexa, Geodon, Seroquel and Abilify), as well as pain killers, and has testified before the FDA and congressional subcommittee members on antidepressants.

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: store.drugawareness.org And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships for the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan. You can even get a whole month of access to the withdrawal CD with tips on rebuilding after the meds, all six of my DVDs, hundreds of radio interviews, lectures, TV interviews I have done over the years PLUS my book on antidepressants with more information than you will find anywhere else for only $30 membership for a month (that is only $5 more than the book alone would cost) at www.drugawareness.org. (Definitely the best option to save outrageous postage charges for those out of the country!)