Abilify alerts and its side effects

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].

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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.

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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