Wednesday, May 2, 2007

FDA :: Proposal for new black box warnings about suicidal thinking, behavior..

In light of all that has been occuring across our country of late, not unexpected to start re-seeing this type of press release become more frequent.. From these fingertips, forget that it is addressing "young adults".. If ANYONE of ANY AGE starts feeling strange, weird, out of sorts, and especially unusually or unexpectedly violent, either suicidally or homicidally, PLEASE seek professional feedback immediately..

Always be aware of, listen to, and know what your body is telling you.. BUT, at the same time, don't let paranoia get the best of you.. Work within yourself to find just that balance of knowing what should be occurring and what is indeed an early alarm for times ahead..

For me, it was Serzone.. The most unbelievably violent, literally saw red emotions came over me in a flash absolutely out of nowhere during the most pleasant, enlightening conversation with a friend.. Can still "see", feel that very moment it occurred..

What coninues to byte about it was that I kept telling the professionals and all I got back was, "Serzone doesn't do that to anyone.." End of discussion. Period.

Wasn't so empowered by others at that Time.. Wish I knew then.. :wink:

Soooo.. Should you find yourself wearing those same shoes, or should you find yourself in a place where you are uncomfortable "complaining", as you might feel it to be, find someone you trust to sit with you in your presence and advocate for change in your meds, treatment.. Be it a family member, friend, member of your church or local civic group, you have the right to have someone help you speak up if you need that accommodation..

If you are still not listened to, become 1) a self-advocate and 2) an advocate for others by turning to places like your local or state mental health advocacy agencies, your local CIL (center for independent living, yes, they're for you, too), and/or state advocacy office.. Don't stop until someone has been able to help you receive accountable mental health care..

For your very Life..

Cyber hugs..

FDA PRESS RELEASE
FOR IMMEDIATE RELEASE
May 2, 2007
P07-77
Media Inquiries: 301-827-6242
Press Officer: Sandy Walsh
Sandy.walsh@fda.hhs.gov.. Consumer Inquiries: 888-INFO-FDA

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today’s actions represent FDA’s commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA’s Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today’s action include:

  • Anafranil (clomipramine)
  • Asendin (amoxapine)
  • Aventyl (nortriptyline)
  • Celexa (citalopram hydrobromide)
  • Cymbalta (duloxetine)
  • Desyrel (trazodone HCl)
  • Elavil (amitriptyline)
  • Effexor (venlafaxine HCl)
  • Emsam (selegiline)
  • Etrafon (perphenazine/amitriptyline)
  • fluvoxamine maleate
  • Lexapro (escitalopram hydrobromide)
  • Limbitrol (chlordiazepoxide/amitriptyline)
  • Ludiomil (maprotiline)
  • Marplan (isocarboxazid)
  • Nardil (phenelzine sulfate)
  • nefazodone HCl
  • Norpramin (desipramine HCl)
  • Pamelor (nortriptyline)
  • Parnate (tranylcypromine sulfate)
  • Paxil (paroxetine HCl)
  • Pexeva (paroxetine mesylate)
  • Prozac (fluoxetine HCl)
  • Remeron (mirtazapine)
  • Sarafem (fluoxetine HCl)
  • Seroquel (quetiapine)
  • Sinequan (doxepin)
  • Surmontil (trimipramine)
  • Symbyax (olanzapine/fluoxetine)
  • Tofranil (imipramine)
  • Tofranil-PM (imipramine pamoate)
  • Triavil (perphenazine/amitriptyline)
  • Vivactil (protriptyline)
  • Wellbutrin (bupropion HCl)
  • Zoloft (sertraline HCl)
  • Zyban (bupropion HCl)

For more information:

1 comment:

Jeffrey Dach MD said...

According to Dr. Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators.

5) False attribution of suicide to the placebo arm.

6) Hiring ghost writers to make the medical articles more favorable.

7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

For more information and links see my
Paxil, Prozac, and SSRI Induced Suicide Newsletter

Jeffrey Dach MD