[Enews] Diabetes Alert
NAMI-NYS Enews
enews at naminys.org
Thu May 10 12:10:23 EDT 2007
Update 05-05
Office of the Ombudsman for
Mental Health and Mental Retardation
<http://www.ombudmhmr.state.mn.us/images/Medical%20Symbol.jpg>
Hyperglycemia and Diabetes Alert
<http://www.ombudmhmr.state.mn.us/images/Medical%20Symbol.jpg>
This Medical Alert is based on the work of the Medical Review
Subcommittee and should be posted prominently. The Office of the
Ombudsman for Mental Health and Mental Retardation works to improve the
services provided to people with disabilities by communicating important
information found in the Medical Review Subcommittee's reviews of deaths
and serious injuries. Thank you for promptly reporting deaths and
serious injuries. You are helping us to meet our mission.
In 2004, the Food and Drug Administration (FDA) asked all manufacturers
of atypical antipsychotic medications to add a warning statement
describing the increased risk of hyperglycemia and diabetes in patients
taking these medications. The atypical antipsychotic class includes
Zyprexa R (olanzapine, Eli Lilly), Clozaril R (clozapine, Novartis),
Risperdal R (risperidone, Janssen), Seroquel R (quetiapine,
AstraZeneca), Geodon R (ziprasidone, Pfizer), and Abilify R
(aripiprazole, Bristol Myers Squibb and Otsuka American Pharmaceutical).
WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or
hyperosmolar coma or death, has been reported in patients treated with
atypical antipsychotics. Assessment of the relationship between atypical
antipsychotic use and glucose abnormalities is complicated by the
possibility of an increased background risk of diabetes mellitus in
patients with schizophrenia and the increasing incidence of diabetes
mellitus in the general population. Given these confounders, the
relationship between atypical antipsychotic use and
hyperglycemia-related adverse events is not completely understood.
However, epidemiological studies suggest an increased risk of
treatment-emergent hyperglycemia-related adverse events in patients
treated with the atypical antipsychotics. Precise risk estimates for
hyperglycemia related adverse events in patients treated with atypical
antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are
started on atypical antipsychotics should be monitored regularly for
worsening of glucose control. Patients with risk factors for diabetes
mellitus (e.g., obesity, family history of diabetes) who are starting
treatment with atypical antipsychotics should undergo fasting blood
glucose testing at the beginning of treatment and periodically during
treatment. Any patient treated with atypical antipsychotics should be
monitored for symptoms of hyperglycemia including polydipsia [too much
thirst], polyuria [release of large amounts of urine], polyphagia
[excessive eating], and weakness. Patients who develop symptoms of
hyperglycemia during treatment with atypical antipsychotics should
undergo fasting blood glucose testing. In some cases, hyperglycemia has
resolved when the atypical antipsychotic was discontinued; however, some
patients required continuation of anti-diabetic treatment despite
discontinuation of the suspect drug.
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#drugs
By the end of August, 2004, all manufacturers of atypical antipsychotics
had complied with the FDA's request.
In February 2004, the American Diabetes Association released the
following statements: "People who take antipsychotic drugs for the
treatment of a variety of mental illnesses may be at increased risk for
obesity, diabetes and high cholesterol - all of which can lead to heart
disease. Because of this, a joint panel of the American Diabetes
Association, American Psychiatric Association, American Association of
Clinical Endocrinologists, and the North American Association for the
Study of Obesity has issued a consensus statement asking doctors to
carefully screen and monitor patients on these medications for signs of
rapid weight gain or other problems that could lead to diabetes, obesity
and heart disease and refer them to specialists if necessary..
Therefore, the panel recommended that doctors prescribing antipsychotic
drugs first perform baseline screenings of:
* Personal and family history of obesity, diabetes, dyslipidemia
(cholesterol and triglyceride levels), blood pressure or cardiovascular
disease;
* Weight and height;
* Waist circumference;
* Blood pressure;
* Fasting plasma glucose; and
* Fasting lipid profile.
In addition to recommending the referral to specialists for clients with
significant weight gain, new onset diabetes, and other cardiovascular
risk factors, the panel recommended "frequent follow-up monitoring of
any patient receiving second generation antipsychotics (SGAs)."
The entire press release can be reviewed at the website of the American
Diabetes Association:
http://www.diabetes.org/for-media/2004-press-releases/jan-27-04.jsp
The FDA's MedWatch Warnings and the joint panel recommendations were too
late for the following clients of the Office of the Ombudsman for Mental
Health and Mental Retardation.
Could This Happen to Your Client?
Case Studies
#1. A 25-year-old woman with psychosis, mild mental retardation,
gastroesophageal reflux disease, and other medical conditions, died on
8/17/2003, the day she was admitted to the hospital. With no known
diagnosis of diabetes, the client was found to have severe ketoacidosis,
which despite interventions, led to her cardiac arrest and death. The
client had been prescribed Zyprexa (since 2002) and Seroquel. Prior to
her death, she had lived in an adult foster care home. She had been on
pass at her parent's home on 8/17/2003 and had been admitted to the
hospital from there. She was under private guardianship. Although she
was under the care of both a psychiatrist and a primary care physician,
neither physician monitored the client for the development of diabetes
despite the expression of concerns about the client's weight gain. The
only record of a blood glucose measurement was on 6/12/2002 when the
client was in for a physical exam.
#2. A 41-year-old man, with chronic paranoid schizophrenia, was found
dead in his apartment on 12/08/2003. An autopsy was performed. His
manner of death was natural, and the immediate cause of death was
attributed to ketoacidosis. The client had been prescribed Clozaril and
had no reported diagnosis of diabetes. He last saw his psychiatrist in
January and August 2003. Records from those visits indicate that no
laboratory tests were ordered, although the client did have his white
blood cell counts checked every two weeks per the Clozaril protocol.
Prior to his death, the client had lived in his own apartment and
received ARMHS services. He last saw his case manager on 12/04/2003.
Although he was under the care of a psychiatrist, the client's last
annual physical had been performed in 1998.
The Medical Review Subcommittee reviewed and closed both of these cases
with the following recommendations:
1. The MRS recommends that clients receiving antipsychotic
medications be monitored for the development of diabetes and receive at
least an annual physical exam.
2. The MRS recommends that the client's case manager and
residential facility (when applicable) audit the client's records to
ensure that annual physical exams are obtained.
3. The MRS requested the development of a Medical Alert to share
with case managers, providers, the Minnesota Medical Association, and
the Minnesota Psychiatric Society.
Office of the Ombudsman for Mental Health and Mental Retardation
Suite 420, Metro Square Building, St. Paul, Minnesota 55101-2117
651-296-3848 or Toll Free 1-800-657-3506 TTY/voice - Minnesota Relay
Service 711 Website: http://www.ombudmhmr.state.mn.us
<http://www.ombudmhmr.state.mn.us/>
May, 2005
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