Antipsychotíc drugs
prescribed to elderly
T
he Office of Inspector General (OIG)
of the U.S. Department of Health &
Human Services released an investigation
report on May 4, that finds finding that
among elderly Medicare patients in nursing
homes, dangerous antipsychotic drugs are
being given predominantly "off label" for
conditions such as dementia, for which these
drugs have not been approved by the U.S.
Food and Drug Administration.
According to an OIG release, the OIG
further found that 88 percent of Medicare
claims for these drugs were associated with
use for dementia, over 50 percent of these
prescriptions were wrongly billed to Medicare,
and 22 percent were administered by
nursing homes in violation of standards set
by the U.S. Centers for Medicare & Medicaid
Services.
"In total, 95 percent (nearly 1.4 million)
of Medicare claims for atypical antipsychotic
drugs were for elderly nursing home residents
diagnosed with off-label conditions
and/or [dementia]," according to the OIG's
Report.
As explained by the OIG's report, "After
FDA approves a drug to be marketed for a
specific use, physicians are permitted to prescribe
that drug for other uses. This is commonly
referred to as off-label use."
Antipsychotic drugs have not been approved
by the FDA for use in treating symptoms
of dementia in the elderly, and the
FDA has warned that they carry serious and
potentially life-threatening risks when used
this way.
As part of the 48-page report released
may 4, the Inspector General attached a
listing eight commonly prescribed "atypical
antipsychotic drugs" and explaining their
most common serious side effects. The listed
drugs include Aripiprazole (Abilify), Clozapine
(Clozaril), Olanzapine (Zyprexa), Olanzapine/
Fluoxetine (Symbyax), Paliperidone (Invega),
Ouetiapine (Seroquel), Risperidone (Risperdal),
and Ziprasidone (Geodon).
All of these drugs were approved by the
FDA for treatment of schizophrenia and bipolar
disorder. Their side effects include a range
Clinical triais
Results for ALL patients
icromet. Inc. announced last
j month that data from a Phase
12 clinical trial of the company's
lead product candidate blinatumomab
in patients with minimal residual disease
positive (MRD) acute lymphoblastic leukemia
(ALL) were published in the May 16*
online edition of {\& Journal of Clinical
Oncology.
In a prepared statement, the Rockville,
Md.-based drugmaker says results of the
study demonstrated that blinatumomab
produced durable remissions in frontline
adult ALL patients at high risk of relapse.
Blinatumomab is the most advanced of a
of conditions, from less serious (e.g. dry
mouth) to potentially life-threatening.
Although these drugs were not approved by
the FDA for treatment of agitation and other
symptoms of dementia and Alzheimer's, the
government has found that they are commonly
being prescribed to the elderly in nursing
homes for these conditions, the release says.
FDA approves type 2
diabetes tablets
The U.S. Food and Drug Administration last
month approved linagliptin (Tradjenta, Boehringer
Ingelheim and Eli Lilly) tablets, used
with diet and exercise, to improve blood glucose
control in adults with type 2 diabetes.
People with type 2 diabetes do not produce
or respond normally to insulin, a hormone
that regulates the amount of glucose
in the blood. Over time, high blood glucose
levels can increase the risk for serious complications,
including heart disease, blindness,
and nerve and kidney damage.
Tradjenta increases the level of hormones
that stimulate the release of insulin after
a meal by blocking the enzyme dipeptidyl
peptidase-4 (DPP-4), which leads to better
blood glucose control, according to a recent
Drug Topics article.
new class of agents — called BiTE — antibodies,
designed to harness the body's T
cells to kill cancer cells.
"ALL patients with residual leukemic
cells in the bone marrow following treatment
with front-line chemotherapy have a
90 percent risk of relapse and a resulting
poor long-term prognosis," says Professor
Max Topp, a member of the Department
of Internal Medicine II at University of
Wuerzburg, and lead author of the publication.
"Results from this study show that
blinatumomab has the potential to fundamentally
change the long-term outcome
for this difficult-to-treat disease."
"Tradjenta tablets are an exciting new
option to help patients manage their type 2
diabetes as it is the first DPP-4 inhibitor approved
at one dosage strength," says John
Gerich MD, professor of medicine. University
of Rochester School of Medicine. "It may be
an appropriate option for people with type
2 diabetes who have not yet been able to
achieve their treatment goals, or may also
help people with this condition who have not
reached their treatment goals with metformin
alone."
Type 2 diabetes is the most common form
of the disease, affecting between 90% and
95% of the 24 million people in the United
States with diabetes. Tradjenta was demonstrated
to be safe and effective in 8 doubleblind,
placebo-
Antipsychotíc drugsprescribed to elderlyThe Office of Inspector General (OIG)of the U.S. Department of Health &Human Services released an investigationreport on May 4, that finds finding thatamong elderly Medicare patients in nursinghomes, dangerous antipsychotic drugs arebeing given predominantly "off label" forconditions such as dementia, for which thesedrugs have not been approved by the U.S.Food and Drug Administration.According to an OIG release, the OIGfurther found that 88 percent of Medicareclaims for these drugs were associated withuse for dementia, over 50 percent of theseprescriptions were wrongly billed to Medicare,and 22 percent were administered bynursing homes in violation of standards setby the U.S. Centers for Medicare & MedicaidServices."In total, 95 percent (nearly 1.4 million)of Medicare claims for atypical antipsychoticdrugs were for elderly nursing home residentsdiagnosed with off-label conditionsand/or [dementia]," according to the OIG'sReport.As explained by the OIG's report, "AfterFDA approves a drug to be marketed for aspecific use, physicians are permitted to prescribethat drug for other uses. This is commonlyreferred to as off-label use."Antipsychotic drugs have not been approvedby the FDA for use in treating symptomsof dementia in the elderly, and theFDA has warned that they carry serious andpotentially life-threatening risks when usedthis way.As part of the 48-page report releasedmay 4, the Inspector General attached alisting eight commonly prescribed "atypicalantipsychotic drugs" and explaining theirmost common serious side effects. The listeddrugs include Aripiprazole (Abilify), Clozapine(Clozaril), Olanzapine (Zyprexa), Olanzapine/Fluoxetine (Symbyax), Paliperidone (Invega),Ouetiapine (Seroquel), Risperidone (Risperdal),and Ziprasidone (Geodon).All of these drugs were approved by theFDA for treatment of schizophrenia and bipolardisorder. Their side effects include a rangeClinical triaisResults for ALL patientsicromet. Inc. announced lastj month that data from a Phase12 clinical trial of the company'slead product candidate blinatumomabin patients with minimal residual diseasepositive (MRD) acute lymphoblastic leukemia(ALL) were published in the May 16*online edition of {\& Journal of ClinicalOncology.In a prepared statement, the Rockville,Md.-based drugmaker says results of thestudy demonstrated that blinatumomabproduced durable remissions in frontlineadult ALL patients at high risk of relapse.Blinatumomab is the most advanced of aof conditions, from less serious (e.g. drymouth) to potentially life-threatening.Although these drugs were not approved bythe FDA for treatment of agitation and othersymptoms of dementia and Alzheimer's, thegovernment has found that they are commonlybeing prescribed to the elderly in nursinghomes for these conditions, the release says.FDA approves type 2diabetes tabletsThe U.S. Food and Drug Administration lastmonth approved linagliptin (Tradjenta, BoehringerIngelheim and Eli Lilly) tablets, usedwith diet and exercise, to improve blood glucosecontrol in adults with type 2 diabetes.People with type 2 diabetes do not produceor respond normally to insulin, a hormonethat regulates the amount of glucosein the blood. Over time, high blood glucoselevels can increase the risk for serious complications,including heart disease, blindness,and nerve and kidney damage.Tradjenta increases the level of hormonesthat stimulate the release of insulin aftera meal by blocking the enzyme dipeptidylpeptidase-4 (DPP-4), which leads to betterblood glucose control, according to a recentDrug Topics article.new class of agents — called BiTE — antibodies,designed to harness the body's Tcells to kill cancer cells."ALL patients with residual leukemiccells in the bone marrow following treatmentwith front-line chemotherapy have a90 percent risk of relapse and a resultingpoor long-term prognosis," says ProfessorMax Topp, a member of the Departmentof Internal Medicine II at University ofWuerzburg, and lead author of the publication."Results from this study show thatblinatumomab has the potential to fundamentallychange the long-term outcomefor this difficult-to-treat disease.""Tradjenta tablets are an exciting newoption to help patients manage their type 2diabetes as it is the first DPP-4 inhibitor approvedat one dosage strength," says JohnGerich MD, professor of medicine. Universityof Rochester School of Medicine. "It may bean appropriate option for people with type2 diabetes who have not yet been able toachieve their treatment goals, or may alsohelp people with this condition who have notreached their treatment goals with metforminalone."Type 2 diabetes is the most common formof the disease, affecting between 90% and95% of the 24 million people in the UnitedStates with diabetes. Tradjenta was demonstratedto be safe and effective in 8 doubleblind,placebo-
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