| Abilify warning, FDA alert, side effects zhion@zhion.com December 22, 2008 |
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. [i.e.
November 5, 2005].
--------------------------------------------------------------------------------
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.
Sales and Market
Citi analyst projects three-year incremental pharmaceutical revenue of ~$3.4 billion in 2011.
The largest contributors to incremental revenues are core in-line products Plavix and Abilify,
which account for 25% and 32% of incremental pharma sales. We believe the street is under
estimating the contribution from the approval of Abilify in the treatment of resistant
depression, but could also be underestimating the competitive threat from LLY/Daiichi
Sankyo's Effient (prasugrel)...We expect BMY's product mix to shift to faster growing, higher
margin biologic/specialty products. [1]
Abilify is expected to face low-cost generic competition soon.
THIS ARTICLE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, CONSULT WITH YOUR
DOCTOR OR CALL Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570. PUBLISHER DOES
NOT GUARANTEE THE ACCURACY OF THIS ARTICLE. [1] Citi Upgrades Bristol-Myers Squibb (BMY) to Buy
www.streetinsider.com December 10, 2008 8:58 AM EST
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. [i.e.
November 5, 2005].
--------------------------------------------------------------------------------
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.
Sales and Market
Citi analyst projects three-year incremental pharmaceutical revenue of ~$3.4 billion in 2011.
The largest contributors to incremental revenues are core in-line products Plavix and Abilify,
which account for 25% and 32% of incremental pharma sales. We believe the street is under
estimating the contribution from the approval of Abilify in the treatment of resistant
depression, but could also be underestimating the competitive threat from LLY/Daiichi
Sankyo's Effient (prasugrel)...We expect BMY's product mix to shift to faster growing, higher
margin biologic/specialty products. [1]
Abilify is expected to face low-cost generic competition soon.
THIS ARTICLE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, CONSULT WITH YOUR
DOCTOR OR CALL Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570. PUBLISHER DOES
NOT GUARANTEE THE ACCURACY OF THIS ARTICLE. [1] Citi Upgrades Bristol-Myers Squibb (BMY) to Buy
www.streetinsider.com December 10, 2008 8:58 AM EST
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DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
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