Bipolar Support Groups.com blog

At times the bridge is very narrow, with planks that are unstable, some even missing. I continue my journey holding on tight as the bridge narrows, and the planks are unsafe taking each step slowly making choices carefully as I move forwards. There are times when the bridge will widen providing me with more space to move about with somewhat ease, but as I continue on not knowing what may lie ahead of me but I will continue now and tomorrow.

My journey I will control it, it will not control me. I will choose where I will go and when I will end my journey.

The road is full of twists, turns, cross roads and valleys. I may stumble but I will get up and continue on to where lies my destination.

Bipolar survivor at its best….

LOL jan

Whether we notice or not all things in life are connected in some way. We live with the intention and continue to learn. The door of our lives that we open today will decide the lives we live. As wee look back, life is different yet somehow it remains the same, everything is relative and all the struggles, fears, hopes and dreams will return again, for life always changes, just as quickly as it remains the same.

But the difference is with each return we always have a hope of a new day for a chance at a better life. The journey of life is connected and everything is relative for the strength and hope will continue to return. LOL Jan

FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated
with rare but potentially fatal skin reactions
Safety Announcement
[12-11-2014]
The U.S. Food and Drug Administration (FDA) is warning that the antipsychotic drug
ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but
serious skin reaction that can progress to affect other parts of the body.

A new warning has been added
to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia
and Systemic Symptoms (DRESS). Patients who have a fever with a rash and/or swollen lymph glands
should seek urgent medical care.

Health care professionals should immediately stop treatment with
ziprasidone if DRESS is suspected.
Ziprasidone is an antipsychotic drug used to treat the serious mental health disorders schizophrenia and
bipolar I disorder. Ziprasidone helps restore certain natural substances in the brain and can decrease
hallucinations, delusions, other psychotic symptoms, and mania.

To work properly, ziprasidone should
be taken every day as prescribed. Patients should not stop taking their medicine or change their dose
without first talking to their health care professional.
DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph
nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also
causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the
blood. DRESS can lead to death.

FDA reviewed information from six patients in whom the signs and symptoms of DRESS appeared
between 11 and 30 days after ziprasidone treatment was started. None of these patients died (see Data
Summary).

Based on this information, FDA required the manufacturer of Geodon to add a new warning
for DRESS to the Warnings and Precautions section of the drug labels for the capsule, oral suspension,
and injection formulations.

We urge health care professionals and patients to report side effects involving ziprasidone to the
FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the
page.

Facts about ziprasidone (Geodon)
• Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder.
• Ziprasidone is marketed under the brand name Geodon, and as generics.
• During 2013, approximately 2.5 million prescriptions for oral formulations of ziprasidone were
dispensed, and approximately 353,000 patients received a prescription for an oral formulation
of ziprasidone through U.S. outpatient retail pharmacies.1
Additional Information for Patients
• Treatment with ziprasidone may cause you to have a rash. The rash can be severe, covering
much of the body. You may also have a fever and other symptoms associated with a serious
condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

• Call your health care professional(s) and seek immediate care if you develop any of the following
signs or symptoms:
o Skin rash
o Fever
o Swollen face
o Swollen lymph glands
• For ziprasidone to work properly, it should be taken every day as prescribed.
• Do not stop taking ziprasidone or change your dose without first talking to your health care
professional.

• Discuss any questions or concerns about ziprasidone with your health care professional.

• Report any side effects you experience to your health care professional and the FDA MedWatch
program, using the information in the “Contact FDA” box at the bottom of the page.
Additional Information for Health Care Professionals

• Make sure your patients know that rash may occur with ziprasidone treatment and may
progress to Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

• Explain the signs and symptoms of severe skin reactions to your patients and tell them when to
seek immediate care.

• DRESS consists of three or more of the following:
o cutaneous reaction (such as rash or exfoliative dermatitis)
o eosinophilia
o fever
o lymphadenopathy, and
o one or more systemic complications such as hepatitis, nephritis, pneumonitis,
myocarditis, pericarditis, and pancreatitis.

• If DRESS is suspected, ziprasidone treatment should be stopped immediately.

• Report adverse reactions involving ziprasidone to the FDA MedWatch program, using the
information in the “Contact FDA” box at the bottom of the page.

1 Source: IMS Health, National Prescription Audit (NPA™) and Total Patient Tracker (TPT). Year 2013, data
extracted October 2014

Data Summary

FDA reviewed six worldwide cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
associated with ziprasidone use and reported to the FDA Adverse Event Reporting System (FAERS).
The six cases were temporally associated with ziprasidone, with a time to onset of symptoms from 11
days to one month after ziprasidone initiation. In three cases, a recurrence of symptoms was reported
following the discontinuation and re-initiation of ziprasidone, with a faster time to onset following the
re-initiation.

Three of the cases reported concomitant use of drugs associated with DRESS. The cases
reported serious outcomes, including hospitalization. There were no cases reporting death. The FAERS
cases support an association between ziprasidone and the development of DRESS because of the
consistency of the case characteristics to the signs and symptoms of DRESS, the temporal relationship
between ziprasidone initiation and the onset of symptoms, and reportedcases of positive re-challenge.
Although there were no fatalities among the reported cases, DRESS is a potentially fatal drug reaction
with a mortality rate of up to 10%.2

The pathogenesis of DRESS is unclear; however, it is thought to be
the result of a combination of genetic and immunologic factors, such as detoxification defects in the
drug metabolism pathway, resulting in toxic metabolite formation and an immune response.

Reactivation of viral infections (herpes virus [HHV-6, HHV-7] or Epstein-Barr Virus [EBV]) may also play a
role by inducing or amplifying the immune reaction. There is currently no specific treatment for DRESS.
The keys to managing DRESS are early recognition of the syndrome, discontinuation of the offending
agent as soon as possible, and supportive care. Treatment with systemic corticosteroids should be
considered in cases with extensive organ involvement.

bipolarandsupport.com

Read the Medication Guide that comes with you or your family member’s antidepressant medicine.
This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant
medicines. Talk to your, or your family member’s, healthcare provider about:
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental illness
What is the most important information I should know about antidepressant medicines,
depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions in some children,
teenagers, and young adults when the medicine is first started.
2. Depression and other serious mental illnesses are the most important causes of suicidal
thoughts and actions. Some people may have a particularly high risk of having suicidal
thoughts or actions. These include people who have (or have a family history of) bipolar illness
(also called manic-depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family
member?
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is first started or when the
dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior,
thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare
provider between visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has any of the following
symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking
(mania)
• other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
• Never stop an antidepressant medicine without first talking to a healthcare
provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is
important to discuss all the risks of treating depression and also the risks of not
treating it. Patients and their families or other caregivers should discuss all treatment
choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider
about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the
medicines that you or your family member takes. Keep a list of all medicines to show
the healthcare provider. Do not start new medicines without first checking with your
healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for
use in children. Talk to your child’s healthcare provider for more information.
This Medication Guide has been approved by the U.S. Food and Drug Administration for
all antidepressants.

LOL Jan

The upcoming fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) will include
a new chapter on Obsessive-Compulsive and Related Disorders to reflect the increasing evidence
of these disorders’ relatedness to one another and distinction from other anxiety disorders, as well as
to help clinicians better identify and treat individuals suffering from these disorders.
Disorders grouped in this new chapter have features in common such as an obsessive preoccupation
and repetitive behaviors. The disorders included in this new chapter have enough similarities to group
them together in the same diagnostic classification but enough important differences between them to
exist as distinct disorders.
Disorders in this chapter include obsessive-compulsive disorder, body dysmorphic disorder and trichotillomania
(hair-pulling disorder), as well as two new disorders: hoarding disorder and excoriation (skinpicking)
disorder.
Hoarding Disorder
Hoarding disorder is characterized by the persistent difficulty discarding or parting with possessions,
regardless of the value others may attribute to these possessions. The behavior usually has harmful effects—emotional,
physical, social, financial, and even legal—for the person suffering from the disorder
and family members. For individuals who hoard, the quantity of their collected items sets them apart
from people with normal collecting behaviors. They accumulate a large number of possessions that
often fill up or clutter active living areas of the home or workplace to the extent that their intended use
is no longer possible.
Symptoms of the disorder cause clinically significant distress or impairment in social, occupational
or other important areas of functioning including maintaining an environment for self and/or others.
While some people who hoard may not be particularly distressed by their behavior, their behavior can
be distressing to other people, such as family members or landlords.
Hoarding disorder is included in DSM-5 because research shows that it is a distinct disorder with distinct
treatments. Using DSM-IV, individuals with pathological hoarding behaviors could receive a diagnosis
of obsessive-compulsive disorder (OCD), obsessive-compulsive personality disorder, anxiety
disorder not otherwise specified or no diagnosis at all, since many severe cases of hoarding are not
accompanied by obsessive or compulsive behavior. Creating a unique diagnosis in DSM-5 will increase
public awareness, improve identification of cases, and stimulate both research and the development of
specific treatments for hoarding disorder.
This is particularly important as studies show that the prevalence of hoarding disorder is estimated at
approximately two to five percent of the population. These behaviors can often be quite severe and
even threatening. Beyond the mental impact of the disorder, the accumulation of clutter can create a
public health issue by completely filling people’s homes and creating fall and fire hazards.

2 • Obsessive Compulsive and Related Disorders
Excoriation (Skin-Picking) Disorder
Excoriation (skin-picking) disorder is characterized by recurrent skin picking resulting in skin lesions.
Individuals with excoriation disorder must have made repeated attempts to decrease or stop the skin
picking, which must cause clinically significant distress or impairment in social, occupational or other
important areas of functioning. The symptoms must not be better explained by symptoms of another
mental disorder.
This disorder is included in DSM-5 because of substantial scientific literature on excoriation’s prevalence,
diagnostic validators and treatment. Studies show that the prevalence of excoriation is estimated
at approximately two to four percent of the population. Resulting problems may include medical issues
such as infections, skin lesions, scarring and physical disfigurement.
Process for a New Diagnosis
New diagnoses were included in DSM-5 only after a comprehensive review of the scientific literature;
full discussion by Work Group members; review by the DSM-5 Task Force, Scientific Review Committee,
and Clinical and Public Health Committee; and, finally, evaluation by the American Psychiatric Association’s
Board of Trustees. Trustees approved the final diagnostic criteria for DSM-5 in December 2012.
DSM is the manual used by clinicians and researchers to diagnose and classify mental disorders. The American Psychiatric
Association (APA) will publish DSM-5 in 2013, culminating a 14-year revision process

Administartion: http://www.bipolarandsupport.com

The definition of attention-deficit/hyperactivity disorder (ADHD) has been updated in the fifth edition
of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to more accurately characterize
the experience of affected adults. This revision is based on nearly two decades of research showing that
ADHD, although a disorder that begins in childhood, can continue through adulthood for some people.
Previous editions of DSM did not provide appropriate guidance to clinicians in diagnosing adults with
the condition. By adapting criteria for adults, DSM-5 aims to ensure that children with ADHD can continue
to get care throughout their lives if needed.
Changes to the Disorder
ADHD is characterized by a pattern of behavior, present in multiple settings (e.g., school and home),
that can result in performance issues in social, educational, or work settings. As in DSM-IV, symptoms
will be divided into two categories of inattention and hyperactivity and impulsivity that include behaviors
like failure to pay close attention to details, difficulty organizing tasks and activities, excessive talking,
fidgeting, or an inability to remain seated in appropriate situations.

Children must have at least six symptoms from either (or both) the inattention group of criteria and
the hyperactivity and impulsivity criteria, while older adolescents and adults (over age 17 years) must
present with five. While the criteria have not changed from DSM-IV, examples have been included to
illustrate the types of behavior children, older adolescents, and adults with ADHD might exhibit. The
descriptions will help clinicians better identify typical ADHD symptoms at each stage of patients’ lives.
Using DSM-5, several of the individual’s ADHD symptoms must be present prior to age 12 years, compared
to 7 years as the age of onset in DSM-IV. This change is supported by substantial research published
since 1994 that found no clinical differences between children identified by 7 years versus later
in terms of course, severity, outcome, or treatment response.
DSM-5 includes no exclusion criteria for people with autism spectrum disorder, since symptoms of both
disorders co-occur. However, ADHD symptoms must not occur exclusively during the course of schizophrenia
or another psychotic disorder and must not be better explained by another mental disorder,
such as a depressive or bipolar disorder, anxiety disorder, dissociative disorder, personality disorder, or
substance intoxication or withdrawal.
Care Beyond Childhood
The ADHD diagnosis in previous editions of DSM was written to help clinicians identify the disorder in
children. Almost two decades of research conclusively show that a significant number of individuals
diagnosed with ADHD as children continue to experience the disorder as adults. Evidence of this came
from studies in which individuals were tracked for years or even decades after their initial childhood
diagnosis. The results showed that ADHD does not fade at a specific age.
Studies also showed that the DSM-IV criteria worked as well for adults as they did for children but that
a lower threshold of symptoms (five instead of six) was sufficient for a reliable diagnosis.

2 • DSM-5 Attention Deficit/Hyperactivity Disorder Fact Sheet
In light of the research findings, DSM-5 makes a special effort to address adults affected by ADHD to
ensure that they are able to get care when needed.
DSM is the manual used by clinicians and researchers to diagnose and classify mental disorders. The American Psychiatric
Association (APA) will publish DSM-5 in 2013, culminating a 14-year revision process.

Administration: http://www.bipolarandsupport.com