Aripiprazole side effects and warning (marketed at Abilify) zhion@zhion.com November 17, 2005
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This is a summary of the most important information about Abilify. For
details, talk to your healthcare professional.
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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.
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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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