| Aripiprazole side effects and warning (marketed at Abilify) zhion@zhion.com November 17, 2005 |
This is a summary of the most important information about Abilify. For
details, talk to your healthcare professional.
--------------------------------------------------------------------------------
FDA ALERT [04/2005] – Abilify is a type of medicine called an atypical
antipsychotic. FDA has found that older patients treated with atypical
antipsychotics for dementia had a higher chance for death than patients
who did not take the medicine. This is not an approved use.
FDA has asked the companies that make these medicines to change their
labels to include this important information.
This information reflects FDA's current analysis of all available data
concerning this drug.
--------------------------------------------------------------------------------
What Is Abilify?
Abilify is in a class of medications called atypical antipsychotics. Antipsychotic
medicines are used to treat symptoms of schizophrenia that may include
hearing voices, seeing things, or sensing things that are not there,
mistaken beliefs or unusual suspiciousness.
Abilify is used to treat mixed or manic episodes in adults who have a
condition called Bipolar I disorder. Bipolar disorder is a mental illness than
causes extreme mood swings.
What Are The Risks?
The following are the major potential risks and side effects of Abilify therapy.
However, this list is not complete.
Abilify and other antipsychotic medications can cause serious problems such
as:
A life-threatening nervous system problem called neuroleptic malignant
syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast
or irregular heart beat, change in blood pressure, and confusion. NMS can
affect your kidneys. NMS is a medical emergency. Call your healthcare
professional right away if you experience these symptoms.
A movement problem called tardive dyskinesia (TD). Call your healthcare
professional right away if you get muscle movements that cannot be
stopped.
High blood sugar and diabetes. Patients with diabetes or who have a higher
chance for diabetes should have their blood sugar checked often.
Strokes have happened in older patients treated for mental illness from
dementia. Abilify is not approved for this use. See FDA Alert.
Other serious side effects with Abilify may include low blood pressure seen
as dizziness, increased heart beat and possibly fainting; seizures; increased
body temperature; and difficulty swallowing.
The most common side effects may include headache, weakness, nausea,
vomiting, constipation, anxiety, problems sleeping, lightheadedness
(dizziness), sleepiness, restlessness and rash.
What Should I Tell My Healthcare Professional?
Before you start taking Abilify, tell your healthcare professional if you:
have or had heart problems
have or had seizures
have or had diabetes or increased blood sugar
are trying to become pregnant, are already pregnant, or are breast-feeding.
drink alcohol
Are There Any Interactions With Drugs or Foods?
Because certain other medications can interact with Abilify review all
medications that you are taking with your healthcare professional, including
those that you take without a prescription.
Your healthcare professional may have to adjust your dose or watch you
more closely if you take the following:
blood pressure medicines
ketoconazole
quinidine
carbamazepine
fluoxetine or paroxetine
Avoid drinking alcohol while taking Abilify.
Is There Anything Else I Need to Know?
Abilify may impair judgment, thinking, or motor skills. You should be careful
in operating machinery, including automobiles, until you know how Abilify
affects you.
It is important to avoid overheating and dehydration while taking Abilify.
Abilify may make it harder to lower your body temperature.
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-
4570
details, talk to your healthcare professional.
--------------------------------------------------------------------------------
FDA ALERT [04/2005] – Abilify is a type of medicine called an atypical
antipsychotic. FDA has found that older patients treated with atypical
antipsychotics for dementia had a higher chance for death than patients
who did not take the medicine. This is not an approved use.
FDA has asked the companies that make these medicines to change their
labels to include this important information.
This information reflects FDA's current analysis of all available data
concerning this drug.
--------------------------------------------------------------------------------
What Is Abilify?
Abilify is in a class of medications called atypical antipsychotics. Antipsychotic
medicines are used to treat symptoms of schizophrenia that may include
hearing voices, seeing things, or sensing things that are not there,
mistaken beliefs or unusual suspiciousness.
Abilify is used to treat mixed or manic episodes in adults who have a
condition called Bipolar I disorder. Bipolar disorder is a mental illness than
causes extreme mood swings.
What Are The Risks?
The following are the major potential risks and side effects of Abilify therapy.
However, this list is not complete.
Abilify and other antipsychotic medications can cause serious problems such
as:
A life-threatening nervous system problem called neuroleptic malignant
syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast
or irregular heart beat, change in blood pressure, and confusion. NMS can
affect your kidneys. NMS is a medical emergency. Call your healthcare
professional right away if you experience these symptoms.
A movement problem called tardive dyskinesia (TD). Call your healthcare
professional right away if you get muscle movements that cannot be
stopped.
High blood sugar and diabetes. Patients with diabetes or who have a higher
chance for diabetes should have their blood sugar checked often.
Strokes have happened in older patients treated for mental illness from
dementia. Abilify is not approved for this use. See FDA Alert.
Other serious side effects with Abilify may include low blood pressure seen
as dizziness, increased heart beat and possibly fainting; seizures; increased
body temperature; and difficulty swallowing.
The most common side effects may include headache, weakness, nausea,
vomiting, constipation, anxiety, problems sleeping, lightheadedness
(dizziness), sleepiness, restlessness and rash.
What Should I Tell My Healthcare Professional?
Before you start taking Abilify, tell your healthcare professional if you:
have or had heart problems
have or had seizures
have or had diabetes or increased blood sugar
are trying to become pregnant, are already pregnant, or are breast-feeding.
drink alcohol
Are There Any Interactions With Drugs or Foods?
Because certain other medications can interact with Abilify review all
medications that you are taking with your healthcare professional, including
those that you take without a prescription.
Your healthcare professional may have to adjust your dose or watch you
more closely if you take the following:
blood pressure medicines
ketoconazole
quinidine
carbamazepine
fluoxetine or paroxetine
Avoid drinking alcohol while taking Abilify.
Is There Anything Else I Need to Know?
Abilify may impair judgment, thinking, or motor skills. You should be careful
in operating machinery, including automobiles, until you know how Abilify
affects you.
It is important to avoid overheating and dehydration while taking Abilify.
Abilify may make it harder to lower your body temperature.
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-
4570
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(Lidocaine)
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Lyrica (pregabalin)
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[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
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Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
INDUSTRY
Foundamental
Science
Colloidal
Stabilization
Drug Product
Development
Patent Application
Product
Development
Product
Ingredients
Colorant
Scale up a batch 1
Drug Delivery
Industry
Drug Delivery -
Smart Bomb
Lotion, Cream,
Preps
Enteric
Coating-Eudragit
Enteric
Coating-Nutrateric
SR
Coating-Aquacoat
Drug Industry
Drug
Competitions
Drug in
Development
Cholesterol-loweri
ng
Drug-Terminologi
es
Packaging
Materials
Market
Drug Dev- 2004
Drug Dev -
2005Q1
Drug Dev- 2005Q2
Drug
Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market
Novo Norkdisk
R&D
Equipment
Blenders
CONTRACT
MANUFACT.
Nutrition
Supplements
NEW DRUGS
Arranon
Actoplus Met
Alfuzosin
Ambien CR
Avastin
Asmanex(R)
Erbitux
(cetuximab)
Gardasil
GRN163
Herceptin
Increlex (rhIGF-1)
Lidoerm
(Lidocaine)
Liraglutide
Lyrica (pregabalin)
Rozerem
Sorafenib
Sutent
Tamsulosin
Torcetrapib
Zometa
OLD DRUGS
Lithium Carbonate
DRUG NOTES
[CONSTRUCT]
Clinical Research
Terminologies
FDA ALERTS
Protein Drug
Market
Niche Market
Orphan Drug
levothyroxine
Protein Drug 1
Protein Drug2
Double-blind
Study
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