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The Label - Where's Waldo?

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RELATIONSHIPS Surviving Antidepressants
 

Taking Action 

THE LABEL - WARNINGS AND PRECAUTIONS
Partners & Spouses - Did you know this was on the label of your loved one’s bottle of antidepressants?  Can you find the hidden phrase that says that you were to be advised by your loved one’s doctor of the need to observe your loved one in case they had any strange behaviors, so that in case they did, you could contact the doctor directly and let them know? 

 

Where's Waldo?

 

blackboxwarning.gif

 

Patients of all ages who are started on antidepressants therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.  Families and caregivers should be advised of the need for close observation and communication with the prescriber.

 

Information by Drug Class at the FDA – published 2009

 

This is a link to one of the documents at the FDA.  You can also search for a specific brand of antidepressant if you want to see that specific current label, as the specific label may be slightly different, but the basic message should be the same.  Several of the antidepressants that we are familiar with will have some version of the following language, as shown on this published document, as part of the WARNINGS AND PRECAUTIONS BOOKLET that is included with EVERY PRESCRIPTION:

 

  • All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
  • The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
  • Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
  • Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers
  • If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms.


Did you, the drug user, hear about this from your doctor?  Did you, the spouse or partner, get advised by this from your loved ones doctor?  
How are you supposed to inform the health care provider?  Phone?  Text message?  Email?  
 
Wait …. Is the goal here to HEAL people?  If there is a problem, to get them OFF OF THESE DRUGS as fast and safely as possible so they get HEALTHY?  If that’s the case, shouldn’t we have a really CLEAR and EASY communication path and process for our patients and families when there IS a problem?  Or, do they need to wait 5 weeks like I did to even KNOW their behavior is related to a medication they are taking … then HUNT for what to do about it … then DETERMINE if they had any right to REPORT observations … and then to try and figure out WHO to even report TO.  Since my boyfriend left me (“I love you but I am not in love with you”, and I-am-so-great-now-that-I-have-no-emotional-memories-of-you-anymore-anyway bit) … It’s been 2 months.  HOW MUCH DAMAGE HAS BEEN DONE TO HIS BRAIN?!?!?!  And is it reversable, and does anyone even care now?  

 

And what about for other spouses/partners who didn’t know they were “supposed” to be monitoring for unusual behavior changes and supposed to be reporting back to the prescriber.  And would the prescribing doctor had KNOWN they had a responsibility to listen and take action?

 

I didn’t know.  I didn’t know my boyfriend’s problems were associated with his antidepressant.  I thought I had gone crazy.  I believed his INSANE CRAZINESS until I STUMBLED onto this site and it HIT ME like a hammer, just like SO MANY OTHER PEOPLE that I wasn’t crazy at all, and that he was NOT in his right mind.  But SOOOOOOOOOOOOOOOOOOOO many of us partners actually think WE have gone nuts at first, until we put two and two together.   

 

I have read 260 unique spouse stories from the Topix forums and ANALYZED them (… more to come on that, and on the 105 unique user stories …) – many of our partners are so med-induced that they aren’t in their right minds anymore and we don’t know WHAT is going on.  And guess what – WE DIDN’T KNOW TO LOOK FOR THAT!!!  Because most of us didn’t get that alert from the prescribing doctor like we were supposed to!

 

It’s most likely not the doctor’s fault.  I asked a couple of doctors – they didn’t even know that language was in the black box of the antidepressant, or in the warnings and precautions inside the box.  And it’s been there for several years.  I asked a couple of therapists.  Nope, they didn’t know it either.  The squirmed about the legalities of contacting a person’s doctor.  Just like everyone else does.  But NOPE!!  We are SUPPOSED TO!  For our loved one’s SAFETY!!!  I guess there isn’t a lot of education going on about this.  

 

See what Peter Breggin says about this specific thing in his book, Medication Madness. 

 

BENEATH THE BLACK BOX, the FDA mandated another new section entitled, “WARNINGS: Clinical Worsening and Suicide Risk,” that applies to children and to adults. It observes, “There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients.” After additional warnings about suicidality in children, it warns that adults “should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.” Because this section warns about the association between suicidality and changes in drug dose for adults, it is tantamount to saying that antidepressants cause suicidality in children and adults—but this implication was lost upon the media and the professional community. Indeed, as I documented in Brain-Disabling Treatments in Psychiatry (2008), the American Psychiatric Association and other members of the psychopharmaceutical complex have been criticizing the FDA for mandating the black-box warning and have been trying to discourage doctors from taking its message seriously. Except for a small decline in prescribing these drugs to children, I have not as yet seen any significant change in the prescribing habits of physicians or in the warnings that they give to their patients. 
The hearings and the data presentations that led to these warnings focused entirely on the newer antidepressants. The drugs under review at that time, according to the March 22, 2004, FDA Talk Paper, were bupropion (Wellbutrin), citalopram (Celexa), fluoxetine (Prozac, Serafem), fluvoxamine (Luvox), mirtazapine (Remeron), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), escitalopram (Lexapro), and venlafaxine (Effexor). These were the drugs most often cited by the public at the two FDA hearings. 17 A more recent product, duloxetine (Cymbalta), shares similar risks.

 

… … …

 

My Need to Do Something: I am devastated that a pill, and the gross, greedy, irresponsibility of this multi-billion-dollar organization, stole the love of my life from me.  My family was shattered.  And the love of my life - his brain continues to be damaged while still on this drug because I don’t even know who to talk to in order to get him the hell off of it, even though he has exhibited almost every single one of the symptoms mentioned in the FDA document, AND in the specific brand of antidepressant that he takes.  

 

I must do something!!   For him.  And for anyone else out there who DOES NOT want their families and loved ones to suffer like this.  NO ONE NEEDS TO EXPERIENCE THIS. EVER.  

 

I am not in any way affiliated or trained in medicine, so I don’t know the laws or regulations around any of this.  All I know is that my boyfriend was hurt.  He’s still suffering.  And I may never ever ever get him back.  Ever.  My family was wronged.  I was wronged.  But I have a voice.  And I am fighting back.  For me, for my family, and for everyone else out there like me.  I may run into walls that say, “I can’t do this or that” – fine.  Maybe those walls can be walked around.  Or knocked down.  Or climbed over.  

 

But enough is enough.  

 

 

TIME FOR ACTION

STEP 1.  LABEL AWARENESS – If you SEE something, SAY something! 

 

  1. HEALTH & SAFETY FIRST: Spouses/Partners - YOU HAVE A RIGHT to talk to your loved one’s health care providers.  Their health and safety should be first!  READ THOSE LABELS.  
  2. WORK WITH DOCTORS: Spouses/Partners - Work with the health care providers to get your loved ones off of these drugs as safely as possible.  Remember – health care providers are probably going to be as blown away as you are that this is even on the warning & precautions because the pharmaceutical companies DID NOT want the doctors to take it seriously. 
  3. TAPER THE RIGHT WAY: This may mean taking it slower. Do not just stop cold turkey because your loved one suddenly showed symptoms – contact your loved one’s doctor.  Our forums have excellent links to how to do this SUCCESSFULLY, including recommended doctors and therapists.  Let them know about this.  You aren’t telling them how to do their job, just giving them new resources to look at, and let them know why.  
  4. COMMUNICATION SYSTEM FOR TALKING TO HEALTH CARE PROVIDERS: We need to RAISE THE BAR with the medical community as well.  They need to create a FAST, EFFICIENT, EASY way for loved ones to communicate to them if these symptoms show themselves, so that doctors can take APPROPRIATE and SAFE action quickly.  Is it an easy phone call?  What if we don’t know who our loved one’s health care provider is?  What should we do?  Is it to 911?  A system needs to be set up, and it needs to be easy and fast and flexible so that doctors and patients can respond quickly and ensure best possible outcomes for patients.  Doctors need to know they can say, “YES I can talk to you about this.”
  5. NO MORE PLAYING “WHERE’S WALDO”:  Yo … muli-billion-dollar drug companies.  How about something simple in the black box label like just changing the font color to red for the sections that talk about “unusual behavior” or “suicidality”.  Or bolder text.  Or an underline.  Or get fancy and animate it.  I dunno, be creative or something.  That might do – for a start.  

    Drug Companies.  You are RESPONSIBLE for ensuring that the medical community KNOWS what to do about “alerting a patient’s family or caregiver about the importance of monitoring behavior changes due to taking your drug”, that the medical community AS A GLOBAL CULTURE is fully TRAINED on how to alert patients and families appropriately … and is fully CAPABLE to IMPLEMENT and MAINTAIN this CULTURE … FOREVER.  If you are incapable of doing this, you are failing the human race.  You’ve launched for some what has become a poison and disguised it as a cure … and then walked away from the consequences.  That’s on you.

    We need to save patients AND their relationships AND the health of human beings, and actually TRANSPARENTLY and PROACTIVELY and ROBUSTLY inform the public of the ACTUAL dangers of the drugs that are being prescribed.  In addition, previous and current drug users and families who have already experienced this pain can provide their own stories and get the word out there.  

 

 

TELL YOUR FRIENDS and FAMILY about those labels.  Tell everyone.  Make sure people know what to look for.  If nothing else, we have a voice.  We can start there.

 

 

Some of the Actual Labels at the FDA:

Celexa: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020822s047lbl.pdf

  • Full Suicidality Black Box warning on Page 1. 
  • Page 8 has bolded text in two locations for getting family members involved.  For those of you who have used Celexa, or have family members that have used it, did your doctors communicate this to you?

Cymbalta: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf

  • Full Suicidality Black Box warning on Page 3.  This is where the “Where’s Waldo” message to families and caregivers is hidden toward the bottom.  
  • Then you are instructed to go to section 5.1 for more information.   That is where the bolded text can bound about closely observing your loved one for clinical worsening – but wait – look below that for more bolded text.  That is where the doctors are told that they are to alert the families about the need to monitor their loved ones, and to “report such symptoms immediately to health care providers”.  Such monitoring should include daily observation by families and caregivers. 

Effexor: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020699s108lbl.pdf
Fluvoxamine: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf
Paxil: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020710s038lbl.pdf
Pexeva: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021299s033lbl.pdf
Pristiq: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021992s042lbl.pdf
Prozac: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf
Sarafem: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf
Symbyax: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021520s042lbl.pdf
Zoloft: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839s74s86s87_20990s35s44s45lbl.pdf

 

Lexapro: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf

 

THIS is what I was supposed to have been advised on by my partner’s health care provider!  So I could “look for the emergence of such symptoms on a day-to-day basis”:

  • Black Box Page 3 – but also see sections 5.1, 17.1, and 8.4
  • Section 5.1 – see also Discontinuation of Treatment with Lexapro, section 2.4
    • Section 2.4 – see also Warnings and Precautions, section 5.3 - 
    • Section 17.1 – Information for Patients, but also for families and caregivers.  
      • 17.1 Information for Patients
        Physicians are advised to discuss the following issues with patients for whom they prescribe Lexapro.
        General Information about Medication Guide
        Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Lexapro and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Lexapro. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.  Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Lexapro.
        Clinical Worsening and Suicide Risk
        Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

 

  • See also 5.1, 5.2, 5.7, 5.9
    • 5.1 (see above)
    • 5.2 – Serotonin Syndrome – “potentially life threatening” – see also 4.1, 2.5, 2.6
      • 4.1 – MAOI risks – see also 2.5 and 5.2
      • 2.5 – switching patient from or to MAOIs – see also 4.1
      • 2.6 – use of Lexapro with Linezolid or Methylene Blue
      • 5.7 – Abnormal Bleeding
      • 5.9 – Angle Closure Glaucoma
      • 8.4 – Pediatric Use – see also 14.1
      • 14.1 – Major Depressive Disorder


 

 

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